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
Anchorage, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Phoenix, Arizona 85004
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Berkeley, California 94704
Beverly Hills, California 90211
Burbank, California 91505
Cameron Park, California 95682
Carmichael, California 95608
Carmichael, California 95608
Castro Valley, California 94546
Davis, California 95616
Elk Grove, California 95758
Fremont, California 94538
Los Angeles, California 90048
Site Public Contact
310-423-8965
Modesto, California 95355
Mountain View, California 94040
Mountain View, California 94040
Napa, California 94558
Site Public Contact
707-521-3830
Novato, California 94945
Palm Springs, California 92262
Site Public Contact
760-416-4730
Palo Alto, California 94301
Rocklin, California 95765
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95816
Sacramento, California 95816
San Francisco, California 94115
San Luis Obispo, California 93401
Santa Cruz, California 95065
Santa Maria, California 93444
Santa Rosa, California 95403
Site Public Contact
707-521-3830
Santa Rosa, California 95403
Santa Rosa, California 95405
Site Public Contact
707-521-3830
Sunnyvale, California 94086
Tarzana, California 91356
Site Public Contact
818-981-3818
Torrance, California 90505
Vallejo, California 94589
Woodland, California 95695
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Denver, Colorado 80206
Denver, Colorado 80210
Denver, Colorado 80218
Durango, Colorado 81301
Durango, Colorado 81301
Golden, Colorado 80401
Golden, Colorado 80401
Lakewood, Colorado 80228
Littleton, Colorado 80122
Longmont, Colorado 80501
Parker, Colorado 80138
Pueblo, Colorado 81004
Thornton, Colorado 80260
Wheat Ridge, Colorado 80033
Frankford, Delaware 19945
Lewes, Delaware 19958
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
Wilmington, Delaware 19801
Lakeland, Florida 33805
Site Public Contact
863-680-7780
Thomasville, Georgia 31792
Boise, Idaho 83706
Boise, Idaho 83712
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Emmett, Idaho 83617
Fruitland, Idaho 83619
Meridian, Idaho 83642
Meridian, Idaho 83642
Nampa, Idaho 83686
Nampa, Idaho 83687
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Alton, Illinois 62002
Site Public Contact
618-463-5623
Aurora, Illinois 60504
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
Carterville, Illinois 62918
Carthage, Illinois 62321
Centralia, Illinois 62801
Chicago, Illinois 60611
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
DeKalb, Illinois 60115
Dixon, Illinois 61021
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815-285-7800
Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Galesburg, Illinois 61401
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309-344-2831
Geneva, Illinois 60134
Kewanee, Illinois 61443
Lake Forest, Illinois 60045
Macomb, Illinois 61455
Mattoon, Illinois 61938
Mount Vernon, Illinois 62864
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618-242-4600
O'Fallon, Illinois 62269
Orland Park, Illinois 60462
Ottawa, Illinois 61350
Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61636
Peru, Illinois 61354
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Rockford, Illinois 61114
Springfield, Illinois 62702
Site Public Contact
217-545-7929
Springfield, Illinois 62702
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800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Warrenville, Illinois 60555
Washington, Illinois 61571
Yorkville, Illinois 60560
Richmond, Indiana 47374
Cedar Rapids, Iowa 52403
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319-365-4673
Cedar Rapids, Iowa 52403
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319-363-2690
Clive, Iowa 50325
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515-241-3305
Clive, Iowa 50325
Council Bluffs, Iowa 51503
Creston, Iowa 50801
Des Moines, Iowa 50314
Des Moines, Iowa 50314
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515-241-3305
West Des Moines, Iowa 50266
Chanute, Kansas 66720
Dodge City, Kansas 67801
El Dorado, Kansas 67042
Garden City, Kansas 67846
Great Bend, Kansas 67530
Hays, Kansas 67601
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785-623-5774
Independence, Kansas 67301
Kingman, Kansas 67068
Lawrence, Kansas 66044
Liberal, Kansas 67905
Manhattan, Kansas 66502
McPherson, Kansas 67460
Newton, Kansas 67114
Olathe, Kansas 66061
Parsons, Kansas 67357
Pratt, Kansas 67124
Salina, Kansas 67401
Salina, Kansas 67401
Topeka, Kansas 66606
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785-295-8000
Wellington, Kansas 67152
Wichita, Kansas 67208
Wichita, Kansas 67214
Wichita, Kansas 67214
Winfield, Kansas 67156
Bardstown, Kentucky 40004
Corbin, Kentucky 40701
Lexington, Kentucky 40504
Lexington, Kentucky 40509
London, Kentucky 40741
Mount Sterling, Kentucky 40353
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Elkton, Maryland 21921
Beverly, Massachusetts 01915
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978-922-3000
Burlington, Massachusetts 01805
Gloucester, Massachusetts 01930
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978-283-4000
Peabody, Massachusetts 01960
Adrian, Michigan 49221
Site Public Contact
517-265-0116
Ann Arbor, Michigan 48106
Brighton, Michigan 48114
Brighton, Michigan 48114
Canton, Michigan 48188
Canton, Michigan 48188
Caro, Michigan 48723
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Dearborn, Michigan 48124
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248-551-7695
Detroit, Michigan 48236
East China Township, Michigan 48054
Farmington Hills, Michigan 48336
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248-551-7695
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Lansing, Michigan 48912
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517-364-9400
Livonia, Michigan 48154
Macomb, Michigan 48044
Marlette, Michigan 48453
Monroe, Michigan 48162
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800-444-3561
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Royal Oak, Michigan 48067
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248-551-7695
Royal Oak, Michigan 48073
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248-551-7695
Royal Oak, Michigan 48073
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248-551-7695
Royal Oak, Michigan 48073
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248-551-7695
Royal Oak, Michigan 48073
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248-551-7695
Royal Oak, Michigan 48073
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248-551-7695
Saginaw, Michigan 48601
Saginaw, Michigan 48604
Sterling Heights, Michigan 48312
Sterling Heights, Michigan 48312
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248-551-7695
Tawas City, Michigan 48764
Troy, Michigan 48084
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248-551-7695
Troy, Michigan 48085
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248-551-7695
Troy, Michigan 48098
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248-551-7695
Warren, Michigan 48088
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
West Branch, Michigan 48661
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Bemidji, Minnesota 56601
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
Site Public Contact
605-312-3320
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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605-312-3320
Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Jackson, Mississippi 39216
Site Public Contact
601-815-6700
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
Site Public Contact
314-251-7058
Bolivar, Missouri 65613
Branson, Missouri 65616
Site Public Contact
417-269-4520
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Site Public Contact
573-651-5550
Farmington, Missouri 63640
Site Public Contact
314-996-5569
Jefferson City, Missouri 65109
Joplin, Missouri 64804
Joplin, Missouri 64804
Kansas City, Missouri 64108
Site Public Contact
816-404-4375
Osage Beach, Missouri 65065
Rolla, Missouri 65401
Rolla, Missouri 65401
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573-458-6379
Saint Joseph, Missouri 64506
Saint Louis, Missouri 63109
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314-353-1870
Saint Louis, Missouri 63128
Saint Louis, Missouri 63131
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314-996-5569
Saint Louis, Missouri 63141
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314-251-7066
Sainte Genevieve, Missouri 63670
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314-996-5569
Springfield, Missouri 65804
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417-269-4520
Springfield, Missouri 65807
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417-269-4520
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Kearney, Nebraska 68847
Lincoln, Nebraska 68510
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Papillion, Nebraska 68046
Glens Falls, New York 12801
Site Public Contact
518-926-6700
Stony Brook, New York 11794
Site Public Contact
800-862-2215
Valley Stream, New York 11580
Asheville, North Carolina 28803
Clyde, North Carolina 28721
Hendersonville, North Carolina 28791
Hendersonville, North Carolina 28792
Pinehurst, North Carolina 28374
Weaverville, North Carolina 28787
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Site Public Contact
701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
Site Public Contact
800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Beavercreek, Ohio 45431
Boardman, Ohio 44512
Centerville, Ohio 45459
Centerville, Ohio 45459
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Dayton, Ohio 45409
Site Public Contact
937-276-8320
Dayton, Ohio 45409
Dayton, Ohio 45415
Dayton, Ohio 45415
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005-1066
Franklin, Ohio 45005
Greenville, Ohio 45331
Greenville, Ohio 45331
Kettering, Ohio 45409
Kettering, Ohio 45429
Maumee, Ohio 43537
Toledo, Ohio 43623
Site Public Contact
800-444-3561
Troy, Ohio 45373
Troy, Ohio 45373
Warren, Ohio 44484
Youngstown, Ohio 44501
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Gresham, Oregon 97030
Site Public Contact
503-413-2150
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97210
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Tualatin, Oregon 97062
Site Public Contact
503-413-1742
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Chadds Ford, Pennsylvania 19317
Collegeville, Pennsylvania 19426
East Stroudsburg, Pennsylvania 18301
Exton, Pennsylvania 19341
Hazleton, Pennsylvania 18201
Media, Pennsylvania 19063
Newtown Square, Pennsylvania 19073
Paoli, Pennsylvania 19301
Wynnewood, Pennsylvania 19096
Providence, Rhode Island 02905
Site Public Contact
401-274-1122
Boiling Springs, South Carolina 29316
Site Public Contact
864-241-6251
Easley, South Carolina 29640
Greenville, South Carolina 29605
Site Public Contact
864-241-6251
Greenville, South Carolina 29605
Site Public Contact
864-241-6251
Greenville, South Carolina 29615
Site Public Contact
864-241-6251
Greer, South Carolina 29650
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864-241-6251
Seneca, South Carolina 29672
Site Public Contact
864-241-6251
West Columbia, South Carolina 29169
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Mechanicsville, Virginia 23116
Midlothian, Virginia 23113
Midlothian, Virginia 23114
Richmond, Virginia 23223
Richmond, Virginia 23226
Richmond, Virginia 23230
Aberdeen, Washington 98520
Bellingham, Washington 98225
Site Public Contact
360-788-8223
Bremerton, Washington 98310
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Shelton, Washington 98584
Vancouver, Washington 98664
Vancouver, Washington 98684
Vancouver, Washington 98686
Site Public Contact
503-413-2150
Walla Walla, Washington 99362
Yelm, Washington 98597
Eau Claire, Wisconsin 54701
Marshfield, Wisconsin 54449
Minocqua, Wisconsin 54548
New Richmond, Wisconsin 54017
Rice Lake, Wisconsin 54868
Stevens Point, Wisconsin 54482
Weston, Wisconsin 54476
Cody, Wyoming 82414
Sheridan, Wyoming 82801
Bayamon, Puerto Rico 00959-5060
Site Public Contact
787-395-7085
Manati, Puerto Rico 00674
Site Public Contact
787-621-4397
San Juan, Puerto Rico 00917
Site Public Contact
787-274-3387
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00936
Site Public Contact
787-763-1296
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.