S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
Purpose
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.
Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Estrogen Receptor Positive
- HER2/Neu Negative
- Progesterone Receptor Positive
- Prognostic Stage IV Breast Cancer AJCC v8
- Elevated CA15-3 or CEA or CA27-29
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- STEP 1 REGISTRATION
- Patients must have a diagnosis of hormone receptor positive (estrogen receptor
positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative,
metastatic (M1) breast cancer and must be receiving or plan to receive first-line
systemic treatment for metastatic disease. (Systemic treatment is any treatment
meant to treat the whole body such as endocrine therapy +/- targeted therapy +/-
chemotherapy).
- NOTE: Participants are eligible if they have either de-novo metastatic breast
cancer and/or recurrent breast cancer from an earlier stage that is now
metastatic
- Patients must be registered to step 1 between 14 days prior to and 60 days after
start of first-line systemic treatment for metastatic disease
- Patients must have been tested for the following breast cancer specific STMs after
diagnosis of metastatic disease and within +/-14 days of initiation of first-line
systemic treatment for metastatic disease:
- CEA (must be tested)
- CA 15-3 or CA 27.29 (at least one of these must be tested)
- At least one of the tested STMs must have been >= 1.5 x the institutional upper
limit of normal at this time.
Testing all three STMs is encouraged but only two are required. Patients must plan to
have the same two STMs tested for the duration that the patient is on protocol-specified
disease monitoring.
- Patients must have systemic radiographic imaging prior to initiation of systemic
therapy or within 30 days of initiation of treatment for metastatic breast cancer
and prior to step 1 registration. Modality of imaging is at the discretion of the
treating physician.
- Note: the treating physician can order additional imaging tests at any point
prior to randomization at their discretion
- Patients must be willing to obtain disease monitoring (imaging and/or serum tumor
markers) from a consistent facility in which the registering site has access to the
results for the duration of the study intervention (312 weeks after step 2
randomization). Imaging and STMs do not need to be completed at the same facility.
- Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell
anemia are not eligible as these could cause falsely elevated STM levels
- Patients with known brain leptomeningeal metastases are not eligible as they may
require regular radiographic monitoring to assess treatment response
- Patients must not be currently enrolled or plan to participate in a first-line
treatment trial for metastatic breast cancer with a defined monitoring schedule
- Patients who are able to complete questionnaires in English or Spanish must
participate in patient-reported outcome (PRO) assessments
- Patients must not be pregnant due to the potential harm to the fetus from radiation
exposure from radiographic imaging
- Except for breast cancer (and previous history of breast cancer), no other prior
malignancy is allowed with the following exceptions:
- Adequately treated basal (or squamous cell) skin cancer
- Any cancer from which the patient has been disease free for five years
- Prior Stage 0 or pre-cancerous lesions that have been removed with clear
margins
- Patients must not have received prior systemic therapy for metastatic breast cancer,
except for their current line of therapy.
- Patients must have decision making capacity and be able to provide informed consent
- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines; use of legally-authorized representative is not permissible for this
study. Remote consent is allowed with adequate documentation.
- 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
- STEP 2 RANDOMIZATION
- Patients must be tested for the breast cancer specific STMs that were tested prior
to STEP 1 Registration between 56 and 140 days after initiation of first-line
systemic therapy for metastatic disease:
- CEA (must be tested)
- CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)
Testing all three STMs is encouraged but only two are required. Patients must plan to
have the same two STMs tested for the duration that the patient is on protocol-specified
disease monitoring.
- At least one of the STMs that was previously elevated must have decreased from the
assessment at step 1 by >= 10% at this time.
- Patients must not have known progression since registration to step 1
- Patients must be registered to step 2 randomization between 56 days and 140 days
after the initiation of first-line systemic therapy for metastatic disease; This
window is inclusive; patients may be registered to Step 2 on day 56 or Day 140.
Patients must have been eligible for Step 1 in order to be eligible for Step 2
Randomization
- Baseline questionnaires must be completed within 28 days prior to step 2
randomization; (Note: Those patients who cannot complete the PRO questionnaires in
English or Spanish can be registered to step 2 without contributing to PRO research)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (usual care) |
Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. |
|
|
Experimental Arm II (serum tumor directed disease monitoring) |
Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression. |
|
Recruiting Locations
Anchorage 5879400, Alaska 5879092 98508
Anchorage 5879400, Alaska 5879092 99504
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
Anchorage 5879400, Alaska 5879092 99508
Fairbanks 5861897, Alaska 5879092 99701
Kingman 5301067, Arizona 5551752 86401
Phoenix 5308655, Arizona 5551752 85004
Tucson 5318313, Arizona 5551752 85704
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Fort Smith 4111410, Arkansas 4099753 72903
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Jonesboro 4116834, Arkansas 4099753 72401
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Bellflower 5327422, California 5332921 90706
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Easton 4353962, Maryland 4361885 21601
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Grand Rapids 4994358, Michigan 5001836 49503
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Bemidji 5017822, Minnesota 5037779 56601
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Las Vegas 5506956, Nevada 5509151 89074
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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
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Las Vegas 5506956, Nevada 5509151 89148
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Las Vegas 5506956, Nevada 5509151 89169
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Pahrump 5509851, Nevada 5509151 89048
Reno 5511077, Nevada 5509151 89502
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Concord 5084868, New Hampshire 5090174 03301
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603-224-2556
Manchester 5089178, New Hampshire 5090174 03103
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800-339-6484
Sewell 4504048, New Jersey 5101760 08080
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87110
Las Cruces 5475352, New Mexico 5481136 88011
Rio Rancho 5487811, New Mexico 5481136 87124
Cooperstown 5113664, New York 5128638 13326
Elmira 5116497, New York 5128638 14905
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607-271-7000
New York 5128581, New York 5128638 10011
New York 5128581, New York 5128638 10019
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10032
Rochester 5134086, New York 5128638 14642
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585-275-5830
Clinton 4461101, North Carolina 4482348 28328
Gastonia 4467732, North Carolina 4482348 28054
Goldsboro 4468261, North Carolina 4482348 27534
Jacksonville 4473083, North Carolina 4482348 28546
Nags Head 4481427, North Carolina 4482348 27959
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
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701-234-6161
Fargo 5059163, North Dakota 5690763 58103
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605-312-3320
Fargo 5059163, North Dakota 5690763 58104
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800-437-4010
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Beavercreek 4506008, Ohio 5165418 45431
Belpre 4506187, Ohio 5165418 45714
Boardman 5147784, Ohio 5165418 44512
Centerville 4508204, Ohio 5165418 45459
Chillicothe 4828890, Ohio 5165418 45601
Cincinnati 4508722, Ohio 5165418 45220
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Cincinnati 4508722, Ohio 5165418 45255
Cleveland 5150529, Ohio 5165418 44111
Columbus 4509177, Ohio 5165418 43213
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Columbus 4509177, Ohio 5165418 43215
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Dayton 4509884, Ohio 5165418 45415
Delaware 5151891, Ohio 5165418 43015
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Dublin 5152333, Ohio 5165418 43016
Dublin 5152333, Ohio 5165418 43016
Findlay 5153924, Ohio 5165418 45840
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Franklin 4512203, Ohio 5165418 45005
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Grove City 4513409, Ohio 5165418 43123
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Independence 5158404, Ohio 5165418 44131
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Lancaster 4516233, Ohio 5165418 43130
Lima 5160783, Ohio 5165418 45801
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419-226-9617
Mansfield 5161723, Ohio 5165418 44903
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Maumee 5162137, Ohio 5165418 43537
Mayfield Heights 5162188, Ohio 5165418 44124
Mount Vernon 5163799, Ohio 5165418 43050
New Albany 5164202, Ohio 5165418 43054
Newark 5164466, Ohio 5165418 43055
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Perrysburg 5166516, Ohio 5165418 43551
Portsmouth 4521816, Ohio 5165418 45662
Sandusky 5170691, Ohio 5165418 44870
Springfield 4525353, Ohio 5165418 45504
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Strongsville 5173237, Ohio 5165418 44136
Toledo 5174035, Ohio 5165418 43608
Toledo 5174035, Ohio 5165418 43623
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800-444-3561
Troy 5174358, Ohio 5165418 45373
Warren 5175865, Ohio 5165418 44484
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Zanesville 4528923, Ohio 5165418 43701
Oklahoma City 4544349, Oklahoma 4544379 73120
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405-752-3402
Baker City 5712169, Oregon 5744337 97814
Bend 5713587, Oregon 5744337 97701
Clackamas 5719308, Oregon 5744337 97015
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Coos Bay 5720495, Oregon 5744337 97420
Newberg 5742726, Oregon 5744337 97132
Ontario 5744166, Oregon 5744337 97914
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Portland 5746545, Oregon 5744337 97213
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Salem 5750162, Oregon 5744337 97301
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Allentown 5178127, Pennsylvania 6254927 18103
Bethlehem 5180225, Pennsylvania 6254927 18017
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Philadelphia 4560349, Pennsylvania 6254927 19107
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Pottstown 5207069, Pennsylvania 6254927 19464
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Pottsville 5207080, Pennsylvania 6254927 17901
Scranton 5211303, Pennsylvania 6254927 18510
Selinsgrove 5211411, Pennsylvania 6254927 17870
State College 5213681, Pennsylvania 6254927 16801
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Westerly 5225631, Rhode Island 5224323 02891
Bluffton 4571722, South Carolina 4597040 29910
Boiling Springs 4571805, South Carolina 4597040 29316
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864-241-6251
Clinton 4575028, South Carolina 4597040 29325
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Easley 4577263, South Carolina 4597040 29640
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Hilton Head Island 4581832, South Carolina 4597040 29926-3827
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Sioux Falls 5231851, South Dakota 5769223 57104
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Collierville 4614748, Tennessee 4662168 38017
Cookeville 4615145, Tennessee 4662168 38501
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Memphis 4641239, Tennessee 4662168 38120
Chesapeake 4752186, Virginia 6254928 23320
Martinsville 4771808, Virginia 6254928 24115
Aberdeen 5785243, Washington 5815135 98520
Bellevue 5786882, Washington 5815135 98004
Bellingham 5786899, Washington 5815135 98225
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360-788-8223
Bremerton 5788054, Washington 5815135 98310
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Everett 5793933, Washington 5815135 98201
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Lacey 5800112, Washington 5815135 98503
Longview 5801617, Washington 5815135 98632
Port Townsend 5807239, Washington 5815135 98368
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Antigo 5244010, Wisconsin 5279468 54409
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La Crosse 5258957, Wisconsin 5279468 54601
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Oconto Falls 5265522, Wisconsin 5279468 54154
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Sheboygan 5272893, Wisconsin 5279468 53081
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Stevens Point 5274644, Wisconsin 5279468 54481
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Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Wausau 5278120, Wisconsin 5279468 54401
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877-405-6866
Wausau 5278120, Wisconsin 5279468 54401
Weston 5278693, Wisconsin 5279468 54476
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
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715-422-7718
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Cheyenne 5821086, Wyoming 5843591 82001
Cody 5821593, Wyoming 5843591 82414
Sheridan 5838198, Wyoming 5843591 82801
Bayamón 4562831, Puerto Rico 00959-5060
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787-395-7085
Manatí 4566137, Puerto Rico 00674
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787-621-4397
San Juan 4568127, Puerto Rico 00917
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787-274-3387
San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00927
San Juan 4568127, Puerto Rico 00936
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787-763-1296
More Details
- NCT ID
- NCT03723928
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care. SECONDARY OBJECTIVES: I. To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population. II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population. TERTIARY OBJECTIVES: I. To assess modality and frequency of disease monitoring testing in the usual care cohort. II. To assess the association of PROs and patient preferences for disease monitoring testing. III. To evaluate predictors of physician preferences for disease monitoring testing. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.