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 Genders
- 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, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Kingman, Arizona 86401
Phoenix, Arizona 85004
Tucson, Arizona 85704
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520-694-8900
Tucson, Arizona 85719
Tucson, Arizona 85719
Fort Smith, Arkansas 72903
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800-378-9373
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
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501-686-8274
Anaheim, California 92806
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Baldwin Park, California 91706
Bellflower, California 90706
Burbank, California 91505
Cameron Park, California 95682
Carmichael, California 95608
Carmichael, California 95608
Dublin, California 94568
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925-875-1677
Elk Grove, California 95758
Emeryville, California 94608
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510-835-9900
Emeryville, California 94608
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510-629-6682
Fontana, California 92335
Irvine, California 92618
Los Angeles, California 90027
Los Angeles, California 90034
Martinez, California 94553-3156
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925-957-5400
Napa, California 94558
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707-521-3830
Oakland, California 94609
Ontario, California 91761
Panorama City, California 91402
Riverside, California 92505
Rocklin, California 95765
Sacramento, California 95816
San Diego, California 92108
San Diego, California 92120
San Luis Obispo, California 93401
San Marcos, California 92078
Santa Maria, California 93444
Santa Rosa, California 95403
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707-521-3830
Santa Rosa, California 95405
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Walnut Creek, California 94597
Woodland Hills, California 91367
Woodland, California 95695
Aurora, Colorado 80012
Boulder, Colorado 80301
Boulder, Colorado 80303
Boulder, Colorado 80304
Centennial, Colorado 80112
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80923
Denver, Colorado 80206
Denver, Colorado 80209
Denver, Colorado 80210
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Durango, Colorado 81301
Durango, Colorado 81301
Englewood, Colorado 80113
Englewood, Colorado 80113
Englewood, Colorado 80113
Englewood, Colorado 80113
Golden, Colorado 80401
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Littleton, Colorado 80120
Littleton, Colorado 80122
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Parker, Colorado 80138
Pueblo, Colorado 81004
Thornton, Colorado 80260
Thornton, Colorado 80260
Derby, Connecticut 06418
Fairfield, Connecticut 06824
Glastonbury, Connecticut 06033
Greenwich, Connecticut 06830
Guilford, Connecticut 06437
Hartford, Connecticut 06105
New Haven, Connecticut 06510
New Haven, Connecticut 06520
North Haven, Connecticut 06473
Orange, Connecticut 06477
Stamford, Connecticut 06902
Torrington, Connecticut 06790
Trumbull, Connecticut 06611
Waterbury, Connecticut 06708
Waterford, Connecticut 06385
Aventura, Florida 33180
Fort Lauderdale, Florida 33308
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Alton, Illinois 62002
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Dixon, Illinois 61021
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Great Bend, Kansas 67530
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Marrero, Louisiana 70072
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Easton, Maryland 21601
Burlington, Massachusetts 01805
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Adrian, Michigan 49221
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Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Escanaba, Michigan 49829
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
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Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49048
Lansing, Michigan 48912
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517-364-9400
Livonia, Michigan 48154
Macomb, Michigan 48044
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Muskegon, Michigan 49444
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616-391-1230
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Warren, Michigan 48093
West Branch, Michigan 48661
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Bemidji, Minnesota 56601
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Fridley, Minnesota 55432
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
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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
Gulfport, Mississippi 39502
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
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314-251-7058
Branson, Missouri 65616
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Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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Chesterfield, Missouri 63017
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314-205-6936
Columbia, Missouri 65212
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Farmington, Missouri 63640
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314-996-5569
Jefferson City, Missouri 65109
Joplin, Missouri 64804
Joplin, Missouri 64804
Kansas City, Missouri 64108
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816-404-4375
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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Saint Louis, Missouri 63131
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314-996-5569
Saint Louis, Missouri 63141
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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
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Concord, New Hampshire 03301
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603-224-2556
Manchester, New Hampshire 03103
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800-339-6484
Sewell, New Jersey 08080
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87110
Las Cruces, New Mexico 88011
Rio Rancho, New Mexico 87124
Cooperstown, New York 13326
Elmira, New York 14905
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607-271-7000
New York, New York 10011
New York, New York 10029
New York, New York 10032
Rochester, New York 14642
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585-275-5830
Clinton, North Carolina 28328
Gastonia, North Carolina 28054
Goldsboro, North Carolina 27534
Jacksonville, North Carolina 28546
Nags Head, North Carolina 27959
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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Fargo, North Dakota 58104
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800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Beavercreek, Ohio 45431
Belpre, Ohio 45714
Boardman, Ohio 44512
Centerville, Ohio 45459
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44111
Columbus, Ohio 43213
Columbus, Ohio 43214
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43219
Columbus, Ohio 43222
Columbus, Ohio 43228
Dayton, Ohio 45415
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005
Greenville, Ohio 45331
Greenville, Ohio 45331
Grove City, Ohio 43123
Grove City, Ohio 43123
Independence, Ohio 44131
Kettering, Ohio 45409
Kettering, Ohio 45429
Lancaster, Ohio 43130
Lima, Ohio 45801
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419-226-9617
Mansfield, Ohio 44903
Mansfield, Ohio 44906
Marietta, Ohio 45750
Marion, Ohio 43302
Maumee, Ohio 43537
Mayfield Heights, Ohio 44124
Mount Vernon, Ohio 43050
New Albany, Ohio 43054
Newark, Ohio 43055
Newark, Ohio 43055
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Sandusky, Ohio 44870
Springfield, Ohio 45504
Springfield, Ohio 45505
Strongsville, Ohio 44136
Toledo, Ohio 43608
Toledo, Ohio 43623
Toledo, Ohio 43623
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Troy, Ohio 45373
Warrensville Heights, Ohio 44122
Warren, Ohio 44484
Westerville, Ohio 43081
Wooster, Ohio 44691
Youngstown, Ohio 44501
Zanesville, Ohio 43701
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
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Salem, Oregon 97301
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Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Danville, Pennsylvania 17822
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East Stroudsburg, Pennsylvania 18301
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Lewisburg, Pennsylvania 17837
Philadelphia, Pennsylvania 19107
Phoenixville, Pennsylvania 19460
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610-983-1908
Pottstown, Pennsylvania 19464
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610-327-7544
Pottsville, Pennsylvania 17901
Scranton, Pennsylvania 18510
Selinsgrove, Pennsylvania 17870
State College, Pennsylvania 16801
Wilkes-Barre, Pennsylvania 18711
Westerly, Rhode Island 02891
Bluffton, South Carolina 29910
Boiling Springs, South Carolina 29316
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864-241-6251
Clinton, South Carolina 29325
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864-241-6251
Easley, South Carolina 29640
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29605
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864-241-6251
Greenville, South Carolina 29615
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864-241-6251
Greer, South Carolina 29650
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864-241-6251
Hilton Head Island, South Carolina 29926-3827
Seneca, South Carolina 29672
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864-241-6251
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Cookeville, Tennessee 38501
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931-783-2714
Memphis, Tennessee 38120
Chesapeake, Virginia 23320
Martinsville, Virginia 24115
Aberdeen, Washington 98520
Bellevue, Washington 98004
Bellingham, Washington 98225
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360-788-8223
Bremerton, Washington 98310
Bremerton, Washington 98310
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
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Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Port Townsend, Washington 98368
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360-344-3091
Renton, Washington 98055
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Seattle, Washington 98112
Seattle, Washington 98122-5711
Seattle, Washington 98122
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Shelton, Washington 98584
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Walla Walla, Washington 99362
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Yelm, Washington 98597
Antigo, Wisconsin 54409
Chippewa Falls, Wisconsin 54729
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Janesville, Wisconsin 53548
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Marshfield, Wisconsin 54449
Medford, Wisconsin 54451
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New Richmond, Wisconsin 54017
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Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
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Stevens Point, Wisconsin 54482
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Wausau, Wisconsin 54401
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877-405-6866
Wausau, Wisconsin 54401
Weston, Wisconsin 54476
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715-422-7718
Wisconsin Rapids, Wisconsin 54494
Cheyenne, Wyoming 82001
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
- 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.