Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Purpose
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Early Stage Triple-Negative Breast Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Participants must have histologically confirmed estrogen receptor (ER)-negative,
progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined
as ER < 5%, PR < 5%, and HER2 negative (per 2020 American Society of Clinical
Oncology [ASCO] College of American Pathologists [CAP] guidelines)
- NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or
PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine
therapy is not recommended/planned by the treating physician
- Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor
clinical stage either
- T2-T4, N0, M0 or
- T1-T3, N1-2, M0
- Note: All participants with clinically suspicious nodes must undergo core
needle biopsy or fine needle biopsy per standard clinical practice to
pathologically confirm nodal status
- Participants must have breast and axillary imaging with mammogram and/or ultrasound
and/or magnetic resonance imaging (MRI) within 49 days prior to randomization
- Note: Participants with bilateral invasive breast cancer are eligible if both
breast cancers are ER-negative, PR-negative, and HER2-negative provided they
meet the other eligibility criteria
- Participants must not have T4/N+, any N3, or inflammatory breast cancer
- Participants must not have metastatic disease (M1)
- Participants must not have received prior systemic therapy or radiation therapy with
curative intent for the current breast cancer
- Participants must not have had previous definitive ipsilateral breast surgery for
the current breast cancer
- Participants must not have current or anticipated use of other investigational
agents while participating in this study
- Participants must not have history of allergic reactions attributed to compounds of
similar chemical or biologic composition as study agents
- Participants must not have severe hypersensitivity (>= grade 3) to pembrolizumab or
any of its excipients
- Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or
anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (e.g. CTLA-4, OX-40, CD137)
- Participants must not be currently participating in or have participated in a study
of an investigational agent or used an investigational device within 28 days prior
to randomization
- Participants must be >= 18 years old
- Participants must have Zubrod performance status of 0-2
- Participants with evidence of peripheral neuropathy must have it at =< grade 1, by
Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28
days prior to randomization
- Participants must have a complete medical history and physical exam within 28 days
prior to randomization
- Hemoglobin >= 9.0 g/dL or >= 5.6 mol/L (within 28 days prior to randomization)
- (Criteria must be met without erythropoietin dependency and without packed red
blood cell transfusion within last 2 weeks)
- Leukocytes >= 3 x 10^3/uL (within 28 days prior to randomization)
- Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to randomization)
- Platelets >= 100 x 10^3/uL (within 28 days prior to randomization)
- Total bilirubin =< 1.5 x institutional upper limit of normal (IULN), OR direct
bilirubin =< IULN for participants with total bilirubin > 1.5 x IULN (unless history
of Gilbert's disease. Participants with history of Gilbert's disease must have total
bilirubin =< 5 x institutional IULN) (within 28 days prior to randomization)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x
institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- Participants must have a serum creatinine =< the IULN OR calculated creatinine
clearance >= 50 mL/min/1.73m^2 using the following Cockcroft-Gault Formula. This
specimen must have been drawn and processed within 28 days prior to registration
- Participants must have adequate cardiac function. Participants must have left
ventricular ejection fraction >= 50% as assessed by either echocardiography (ECHO)
or multigated acquisition scan (MUGA) assessed within 28 days prior to registration.
Participants with known history or current symptoms of cardiac disease, or history
of treatment with cardiotoxic agents, must have a clinical risk assessment of
cardiac function using the New York Heart Association Functional Classification and
must be class 2B or better
- Participants with known human immunodeficiency virus (HIV)-infection must be on
effective anti-retroviral therapy at randomization and have undetectable viral load
test on the most recent test results obtained within 6 months prior to randomization
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load while on suppressive therapy on the most recent test
results obtained within 6 months prior to randomization, if indicated
- Note: No testing for Hepatitis B is required unless mandated by local health
authority
- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. Participants currently being treated for HCV infection must have
undetectable HCV viral load test on the most recent test results obtained within 6
months prior to randomization, if indicated
- Note: No testing for hepatitis C is required unless mandated by local health
authority
- Participants with history of diabetes must not have uncontrolled diabetes in the
opinion of the treating investigator
- Participants must not have uncontrolled hypertension in the opinion of the treating
investigator
- Participants must not have had a major surgery within 14 days prior to
randomization. Participants must have fully recovered from the effects of prior
major surgery in the opinion of the treating investigator
- Participants must not have severe or active infections within 14 days prior to
Randomization, including but not limited to hospitalization for infection,
bacteremia, or severe pneumonia
- Participants must not have a diagnosis of immunodeficiency and be receiving chronic
systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
or any other form of immunosuppressive therapy within 7 days prior to randomization
- Participants must not have active autoimmune disease that has required systemic
treatment in 2 years prior to randomization (i.e., with use of disease modifying
agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.,
thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or
pituitary insufficiency) is not considered a form of systemic treatment
- Participants must not have a history of (non-infectious) pneumonitis that required
steroids, or has current (non-infectious) pneumonitis
- Participants must not have received a live vaccine within 30 days prior to
randomization. Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever,
rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed; however,
intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live
attenuated vaccines and are not allowed
- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the treatment regimen
- Participants must not be pregnant or nursing. Individuals who are of reproductive
potential must have agreed to use an effective contraceptive method with details
provided as a part of the consent process. A person who has had menses at any time
in the preceding 12 consecutive months or who has semen likely to contain sperm is
considered to be of "reproductive potential." In addition to routine contraceptive
methods, "effective contraception" also includes refraining from sexual activity
that might result in pregnancy and surgery intended to prevent pregnancy (or with a
side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy,
bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in
the semen
- Participants must have one (1) physical 4-5-micron single hematoxylin and eosin
(H&E) slide from the archival pretreatment diagnostic biopsy available for
submission
- Participants must be offered the opportunity to participate in specimen banking.
With participant consent, specimens must be collected and submitted via the
Southwest Oncology Group (SWOG) Specimen Tracking System
- Participants who can complete questionnaires in English, Spanish, or French must be
offered the opportunity to participate in the Patient-Reported Outcome study
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration
process the treating institution's identity is provided in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered in the system
- Participants must be informed of the investigational nature of this study and
must sign and give informed consent in accordance with institutional and
federal guidelines
- For participants with impaired decision-making capabilities, legally authorized
representatives may sign and give informed consent on behalf of study
participants in accordance with applicable federal, local, and Central
Institutional Review Board (CIRB) regulations
- As part of the registration process the treating institution's identity is provided
in order to ensure that the current (within 365 days) date of institutional review
board approval for this study has been entered in the system
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (usual chemo-immunotherapy) |
Patients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. |
|
|
Experimental Arm II (shorter chemo-immunotherapy) |
Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Anchorage 5879400, Alaska 5879092 99508
Fairbanks 5861897, Alaska 5879092 99701
Kingman 5301067, Arizona 5551752 86401
Phoenix 5308655, Arizona 5551752 85004
Fayetteville 4110486, Arkansas 4099753 72703
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Oak Lawn 4904365, Illinois 4896861 60453
Oak Park 4904381, Illinois 4896861 60304
Orland Park 4904937, Illinois 4896861 60462
Orland Park 4904937, Illinois 4896861 60462
Ottawa 4905006, Illinois 4896861 61350
Park Ridge 4905367, Illinois 4896861 60068
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847-384-3621
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peoria 4905687, Illinois 4896861 61636
Peru 4905770, Illinois 4896861 61354
Peru 4905770, Illinois 4896861 61354
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815-664-4141
Princeton 4906818, Illinois 4896861 61356
Rockford 4907959, Illinois 4896861 61114
Shiloh 4249910, Illinois 4896861 62269
Skokie 4911600, Illinois 4896861 60076
Springfield 4250542, Illinois 4896861 62702
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217-545-7929
Springfield 4250542, Illinois 4896861 62702
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800-444-7541
Springfield 4250542, Illinois 4896861 62781
Urbana 4914570, Illinois 4896861 61801
Warrenville 4915525, Illinois 4896861 60555
Washington 4915545, Illinois 4896861 61571
Yorkville 4917298, Illinois 4896861 60560
Zion 4917358, Illinois 4896861 60099
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844-793-0745
Avon 4254021, Indiana 4921868 46123
Carmel 4255466, Indiana 4921868 46032
Crown Point 4919451, Indiana 4921868 46307
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219-310-2550
Crown Point 4919451, Indiana 4921868 46307
Dyer 4919820, Indiana 4921868 46311
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219-924-8178
Hobart 4921476, Indiana 4921868 46342
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219-947-1795
Hobart 4921476, Indiana 4921868 46342
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46312
Munster 4924014, Indiana 4921868 46321
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219-836-3349
Munster 4924014, Indiana 4921868 46321
New Albany 4262045, Indiana 4921868 47150
Richmond 4263681, Indiana 4921868 47374
South Bend 4926563, Indiana 4921868 46601
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800-284-7370
Valparaiso 4927537, Indiana 4921868 46383
Ames 4846834, Iowa 4862182 50010
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515-956-4132
Ames 4846834, Iowa 4862182 50010
Ankeny 4846960, Iowa 4862182 50023
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515-241-3305
Bettendorf 4848489, Iowa 4862182 52722
Boone 4849051, Iowa 4862182 50036
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515-956-4132
Cedar Rapids 4850751, Iowa 4862182 52403
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319-365-4673
Cedar Rapids 4850751, Iowa 4862182 52403
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319-363-2690
Clive 4852065, Iowa 4862182 50325
Clive 4852065, Iowa 4862182 50325
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515-241-3305
Creston 4853078, Iowa 4862182 50801
Des Moines 4853828, Iowa 4862182 50309
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515-241-6727
Des Moines 4853828, Iowa 4862182 50309
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515-241-3305
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
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515-241-3305
Fort Dodge 4857486, Iowa 4862182 50501
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515-956-4132
Iowa City 4862034, Iowa 4862182 52242
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800-237-1225
Jefferson 4862482, Iowa 4862182 50129
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515-956-4132
Marshalltown 4866371, Iowa 4862182 50158
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515-956-4132
Waukee 4880981, Iowa 4862182 50263
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515-241-3305
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
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515-875-9815
Chanute 4269392, Kansas 4273857 66720
Dodge City 5445298, Kansas 4273857 67801
El Dorado 4270863, Kansas 4273857 67042
Garden City 5445439, Kansas 4273857 67846
Great Bend 4272340, Kansas 4273857 67530
Hays 4272782, Kansas 4273857 67601
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785-623-5774
Independence 4273359, Kansas 4273857 67301
Kingman 4273978, Kansas 4273857 67068
Lawrence 4274277, Kansas 4273857 66044
Liberal 5445820, Kansas 4273857 67905
Manhattan 4274994, Kansas 4273857 66502
McPherson 4275261, Kansas 4273857 67460
Newton 4276248, Kansas 4273857 67114
Olathe 4276614, Kansas 4273857 66061
Parsons 4277011, Kansas 4273857 67357
Pittsburg 4277241, Kansas 4273857 66762
Pittsburg 4277241, Kansas 4273857 66762
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888-446-3729
Pratt 4277752, Kansas 4273857 67124
Salina 4278890, Kansas 4273857 67401
Salina 4278890, Kansas 4273857 67401
Topeka 4280539, Kansas 4273857 66606
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785-295-8000
Wellington 4281386, Kansas 4273857 67152
Wichita 4281730, Kansas 4273857 67208
Wichita 4281730, Kansas 4273857 67214
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Winfield 4281897, Kansas 4273857 67156
Bardstown 4283133, Kentucky 6254925 40004
Corbin 4288656, Kentucky 6254925 40701
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859-523-1934
Corbin 4288656, Kentucky 6254925 40701
Elizabethtown 4290988, Kentucky 6254925 42701
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270-706-5470
Lexington 4297983, Kentucky 6254925 40503
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859-260-6425
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40509
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866-213-3025
Lexington 4297983, Kentucky 6254925 40509
Lexington 4297983, Kentucky 6254925 40536
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859-257-3379
London 4298960, Kentucky 6254925 40741
Louisville 4299276, Kentucky 6254925 40207
Mount Sterling 4301683, Kentucky 6254925 40353
Owensboro 4303436, Kentucky 6254925 42303
Paducah 4048662, Kentucky 6254925 42003
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270-575-2928
Paducah 4048662, Kentucky 6254925 42003
Marrero 4332628, Louisiana 4331987 70072
Monroe 4333669, Louisiana 4331987 71202
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
Shreveport 4341513, Louisiana 4331987 71103
Augusta 4957003, Maine 4971068 04330
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207-626-4855
Kennebunk 4968729, Maine 4971068 04043
Rockport 4976817, Maine 4971068 04856
South Portland 4979244, Maine 4971068 04106
Topsham 4980927, Maine 4971068 04086
Westbrook 4982753, Maine 4971068 04092
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207-303-3300
Aberdeen 4346913, Maryland 4361885 21001
Baltimore 4347778, Maryland 4361885 21201
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800-888-8823
Bel Air 4348240, Maryland 4361885 21014
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443-643-3010
Cumberland 4352681, Maryland 4361885 21502
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240-964-1400
Elkton 4354234, Maryland 4361885 21921
Beverly 4930505, Massachusetts 6254926 01915
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978-922-3000
Boston 4930956, Massachusetts 6254926 02118
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617-638-8265
Boston 4930956, Massachusetts 6254926 02215
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617-667-9925
Burlington 4931737, Massachusetts 6254926 01805
Gloucester 4937829, Massachusetts 6254926 01930
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978-283-4000
Lowell 4942618, Massachusetts 6254926 01854
Peabody 4946863, Massachusetts 6254926 01960
Winchester 4955884, Massachusetts 6254926 01890
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781-756-5000
Worcester 4956184, Massachusetts 6254926 01655
Alma 4984049, Michigan 5001836 48801
Alpena 4984075, Michigan 5001836 49707
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48109
Battle Creek 4985153, Michigan 5001836 49017
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48116
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800-865-1125
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Clinton Township 4989133, Michigan 5001836 48038
Dearborn 4990510, Michigan 5001836 48124
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248-551-7695
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48202
Detroit 4990729, Michigan 5001836 48236
East China Township, Michigan 5001836 48054
Escanaba 4992232, Michigan 5001836 49829
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48336
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248-551-7695
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Gladwin 4993985, Michigan 5001836 48624
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Jackson 4997384, Michigan 5001836 49201
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49009
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574-647-7370
Kalamazoo 4997787, Michigan 5001836 49048
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574-647-7370
Lansing 4998830, Michigan 5001836 48910
Lansing 4998830, Michigan 5001836 48912
Livonia 4999837, Michigan 5001836 48154
Macomb 5000473, Michigan 5001836 48044
Macomb 5000473, Michigan 5001836 48044
Midland 5001929, Michigan 5001836 48670
Mount Pleasant 5002714, Michigan 5001836 48858
Muskegon 5003132, Michigan 5001836 49444
Niles 5003514, Michigan 5001836 49120
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616-391-1230
Norton Shores 5004005, Michigan 5001836 49444
Novi 5004062, Michigan 5001836 48374
Novi 5004062, Michigan 5001836 48377
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Reed City 5006946, Michigan 5001836 49677
Royal Oak 5007804, Michigan 5001836 48067
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Saginaw 5007989, Michigan 5001836 48601
Saint Joseph 5008327, Michigan 5001836 49085
Saint Joseph 5008327, Michigan 5001836 49085
Southfield 5010636, Michigan 5001836 48075
Sterling Heights 5011148, Michigan 5001836 48312
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248-551-7695
Tawas City 5011900, Michigan 5001836 48764
Traverse City 5012495, Michigan 5001836 49684
Troy 5012639, Michigan 5001836 48084
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248-551-7695
Troy 5012639, Michigan 5001836 48085
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248-551-7695
Troy 5012639, Michigan 5001836 48098
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248-551-7695
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
West Bloomfield 7259621, Michigan 5001836 48322
Wyoming 5015618, Michigan 5001836 49519
Ypsilanti 5015688, Michigan 5001836 48106
Ypsilanti 5015688, Michigan 5001836 48197
Aitkin 5015978, Minnesota 5037779 56431
Baxter 5017396, Minnesota 5037779 56425
Site Public Contact
218-828-2880
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Burnsville 5019767, Minnesota 5037779 55337
Cambridge 5020068, Minnesota 5037779 55008
Coon Rapids 5022025, Minnesota 5037779 55433
Crosslake 5023482, Minnesota 5037779 56442
Site Public Contact
218-692-1010
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Ely 5025627, Minnesota 5037779 55731
Site Public Contact
218-365-7900
Fosston 5027191, Minnesota 5037779 56542
Hibbing 5030005, Minnesota 5037779 55746
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218-786-3308
International Falls 5031404, Minnesota 5037779 56649
Site Public Contact
218-283-9431
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Minneapolis 5037649, Minnesota 5037779 55454
Monticello 5038045, Minnesota 5037779 55362
Moose Lake 5038132, Minnesota 5037779 55767
Site Public Contact
218-485-4481
New Ulm 5039173, Minnesota 5037779 56073
Park Rapids 5040822, Minnesota 5037779 56470
Pequot Lakes 5041146, Minnesota 5037779 56472
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218-568-4416
Pine River 5041664, Minnesota 5037779 56474
Site Public Contact
218-587-4416
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Saint Cloud 5044407, Minnesota 5037779 56303
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Staples 5048555, Minnesota 5037779 56479
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218-894-7870
Stillwater 5048814, Minnesota 5037779 55082
Thief River Falls 5049970, Minnesota 5037779 56701
Site Public Contact
605-312-3320
Virginia 5051468, Minnesota 5037779 55792
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Worthington 5053460, Minnesota 5037779 56187
Site Public Contact
605-312-3320
Wyoming 5053526, Minnesota 5037779 55092
Columbus 4422442, Mississippi 4436296 39705
Grenada 4428539, Mississippi 4436296 38901
Jackson 4431410, Mississippi 4436296 39216
Site Public Contact
601-815-6700
New Albany 4438121, Mississippi 4436296 38652
Oxford 4440076, Mississippi 4436296 38655
Southhaven 4446702, Mississippi 4436296 38671
Ballwin 4375663, Missouri 4398678 63011
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888-446-3729
Bolivar 4377835, Missouri 4398678 65613
Branson 4378219, Missouri 4398678 65616
Site Public Contact
417-269-4520
Cape Girardeau 4379966, Missouri 4398678 63703
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888-446-3729
Cape Girardeau 4379966, Missouri 4398678 63703
City of Saint Peters 4407237, Missouri 4398678 63376
Creve Coeur 4382837, Missouri 4398678 63141
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Joplin 4392768, Missouri 4398678 64804
Joplin 4392768, Missouri 4398678 64804
Kansas City 4393217, Missouri 4398678 64108
Site Public Contact
816-404-4375
Osage Beach 4402040, Missouri 4398678 65065
Rolla 4406282, Missouri 4398678 65401
Site Public Contact
573-458-6379
Rolla 4406282, Missouri 4398678 65401
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
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314-996-5569
Springfield 4409896, Missouri 4398678 65804
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417-269-4520
Springfield 4409896, Missouri 4398678 65807
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417-269-4520
St Louis 4407066, Missouri 4398678 63109
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888-446-3729
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63131
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314-996-5569
St Louis 4407066, Missouri 4398678 63136
St Louis 4407066, Missouri 4398678 63141
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314-251-7066
Sullivan 4410669, Missouri 4398678 63080
Site Public Contact
314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
Site Public Contact
314-996-5569
Washington 4413621, Missouri 4398678 63090
Site Public Contact
636-390-1600
Anaconda 5637146, Montana 5667009 59711
Billings 5640350, Montana 5667009 59101
Billings 5640350, Montana 5667009 59102
Site Public Contact
800-648-6274
Bozeman 5641727, Montana 5667009 59715
Butte 5642934, Montana 5667009 59701
Site Public Contact
406-723-2621
Great Falls 5655240, Montana 5667009 59405
Great Falls 5655240, Montana 5667009 59405
Havre 5656497, Montana 5667009 59501
Kalispell 5660340, Montana 5667009 59901
Missoula 5666639, Montana 5667009 59802
Missoula 5666639, Montana 5667009 59804
Bellevue 5063805, Nebraska 5073708 68123
Grand Island 5069297, Nebraska 5073708 68803
Kearney 5071348, Nebraska 5073708 68847
Omaha 5074472, Nebraska 5073708 68118
Site Public Contact
402-559-5600
Omaha 5074472, Nebraska 5073708 68122
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68131
Omaha 5074472, Nebraska 5073708 68198
Carson City 5501344, Nevada 5509151 89703
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Henderson 5505411, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89074
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89103
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89106
Las Vegas 5506956, Nevada 5509151 89109
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89113
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89135
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89144
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89169
Las Vegas 5506956, Nevada 5509151 89169
Pahrump 5509851, Nevada 5509151 89048
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89503
Reno 5511077, Nevada 5509151 89509
Concord 5084868, New Hampshire 5090174 03301
Site Public Contact
603-224-2556
Manchester 5089178, New Hampshire 5090174 03103
Site Public Contact
800-339-6484
Cherry Hill 4501198, New Jersey 5101760 08002
Englewood 5097672, New Jersey 5101760 07631
Site Public Contact
201-894-3456
Moorestown 4503106, New Jersey 5101760 08057
Morristown 5101427, New Jersey 5101760 07960
Site Public Contact
973-971-5900
Red Bank 5103159, New Jersey 5101760 07701
Site Public Contact
732-530-2382
Sewell 4504048, New Jersey 5101760 08080
Summit 5105127, New Jersey 5101760 07902
Site Public Contact
908-522-2043
Vineland 4504621, New Jersey 5101760 08360
Site Public Contact
856-641-7933
Voorhees Township 5105860, New Jersey 5101760 08043
Bay Shore 5108169, New York 5128638 11706
Site Public Contact
516-734-8896
Brooklyn 5110302, New York 5128638 11220
Glens Falls 5118693, New York 5128638 12801
Site Public Contact
518-926-6700
Greenlawn 5119377, New York 5128638 11740
Site Public Contact
516-734-8896
Lake Success 5123853, New York 5128638 11042
Site Public Contact
516-734-8896
Mineola 5127134, New York 5128638 11501
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10065
Site Public Contact
212-434-4460
Poughkeepsie 5132143, New York 5128638 12601
Site Public Contact
845-483-6483
Rochester 5134086, New York 5128638 14623
Southampton 5139030, New York 5128638 11968
Site Public Contact
631-638-7400
Staten Island 5139568, New York 5128638 10305
Site Public Contact
718-226-8888
Stony Brook 5139865, New York 5128638 11794
Site Public Contact
800-862-2215
Webster 5143495, New York 5128638 14580
Asheboro 4453035, North Carolina 4482348 27205
Asheville 4453066, North Carolina 4482348 28803
Burlington 4458228, North Carolina 4482348 27215
Chapel Hill 4460162, North Carolina 4482348 27599
Clinton 4461101, North Carolina 4482348 28328
Clyde 4461150, North Carolina 4482348 28721
Gastonia 4467732, North Carolina 4482348 28054
Goldsboro 4468261, North Carolina 4482348 27534
Greensboro 4469146, North Carolina 4482348 27403
Greensboro 4469146, North Carolina 4482348 27410
Hendersonville 4470592, North Carolina 4482348 28792
Hillsborough 4471241, North Carolina 4482348 27278
Jacksonville 4473083, North Carolina 4482348 28546
Pinehurst 4485272, North Carolina 4482348 28374
Reidsville 4487682, North Carolina 4482348 27320
Weaverville 4497912, North Carolina 4482348 28787
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
701-234-6161
Fargo 5059163, North Dakota 5690763 58103
Site Public Contact
605-312-3320
Fargo 5059163, North Dakota 5690763 58104
Site Public Contact
800-437-4010
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Jamestown 5059836, North Dakota 5690763 58401
Akron 5145476, Ohio 5165418 44304
Alliance 5145607, Ohio 5165418 44601
Site Public Contact
330-363-1250
Barberton 5146491, Ohio 5165418 44203
Beavercreek 4506008, Ohio 5165418 45431
Boardman 5147784, Ohio 5165418 44512
Canton 5149222, Ohio 5165418 44710
Centerville 4508204, Ohio 5165418 45459
Centerville 4508204, Ohio 5165418 45459
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Columbus 4509177, Ohio 5165418 43210
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Site Public Contact
937-276-8320
Dayton 4509884, Ohio 5165418 45415
Dayton 4509884, Ohio 5165418 45415
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Franklin 4512203, Ohio 5165418 45005-1066
Franklin 4512203, Ohio 5165418 45005
Greenville 5156493, Ohio 5165418 45331
Greenville 5156493, Ohio 5165418 45331
Site Public Contact
937-569-7515
Greenville 5156493, Ohio 5165418 45331
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Medina 5162512, Ohio 5165418 44256
Troy 5174358, Ohio 5165418 45373
Troy 5174358, Ohio 5165418 45373
Warren 5175865, Ohio 5165418 44484
Youngstown 5177568, Ohio 5165418 44501
Lawton 4540737, Oklahoma 4544379 73505
Site Public Contact
877-231-4440
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73120
Site Public Contact
405-752-3402
Baker City 5712169, Oregon 5744337 97814
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
Coos Bay 5720495, Oregon 5744337 97420
Gresham 5729485, Oregon 5744337 97030
Site Public Contact
503-413-2150
Hood River 5731777, Oregon 5744337 97031
Newberg 5742726, Oregon 5744337 97132
Ontario 5744166, Oregon 5744337 97914
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97210
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Redmond 5747882, Oregon 5744337 97756
Site Public Contact
541-706-2909
Tualatin 5757506, Oregon 5744337 97062
Site Public Contact
503-413-1742
Allentown 5178127, Pennsylvania 6254927 18103
Bethlehem 5180225, Pennsylvania 6254927 18017
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Providence 5224151, Rhode Island 5224323 02903
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Sioux Falls 5231851, South Dakota 5769223 57104
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Collierville 4614748, Tennessee 4662168 38017
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Austin 4671654, Texas 4736286 78701
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Bayamón 4562831, Puerto Rico 00959-5060
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San Juan 4568127, Puerto Rico 00917
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San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00936
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More Details
- NCT ID
- NCT05929768
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVE: I. To assess whether participants with early stage triple negative breast cancer (TNBC) randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab. SECONDARY OBJECTIVES: I. To compare pathological complete response (pCR) and residual cancer burden (RCB) rates by randomized arm. II. To compare pCR and RCB rates between randomized arms by tumor infiltrating lymphocytes (TIL) status. III. To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL enriched subgroups. IV. To compare distant relapse-free survival and overall survival by randomized arm. V. To compare invasive breast cancer-free survival after surgery between randomized arms in pCR and residual disease groups. VI. To compare the safety and tolerability by randomized arm among those that initiate therapy. TRANSLATIONAL MEDICINE OBJECTIVE: I. To evaluate concordance and accuracy of an automated stromal TIL (sTIL) algorithm versus (vs.) central pathologist assessed sTILs quantification. PATIENT REPORTED OUTCOME (PRO) OBJECTIVES: I. To compare patient-reported fatigue at 3 weeks after the last neoadjuvant systemic therapy (NAST) dose and, separately, at 18 months after randomization, using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-7a in participants undergoing NAST with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy. (Quality of Life, Primary) II. To compare physical function experienced by participants undergoing neoadjuvant systemic chemotherapy (NAST) with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy, within 3-5 weeks post last neoadjuvant systemic therapy dose using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) III. To compare physical function experienced by participants undergoing NAST taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy at 18 months post registration using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) IV. To compare other PROMIS-29 Profile subscale scores (sleep disturbance, depression, anxiety, social, pain interference, and pain sensitivity) and GP5 question response by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) V. To compare the GP-5 item scores by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) VI. To compare select patient-reported outcomes using the Common Terminology Criteria for Adverse Events (PRO-CTCAE) by arm. (Patient-Reported Symptoms of Treatment) BANKING OBJECTIVE: I. To bank physical specimens and digital slides for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive paclitaxel intravenously (IV), carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. ARM II: Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. Patients are followed up every 6 months for the first 2 years and then annually until 5 years from registration.