S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
Launched by SWOG CANCER RESEARCH NETWORK · Oct 25, 2018
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The S1703 clinical trial is looking at a new way to monitor patients with hormone receptor-positive, HER2-negative metastatic breast cancer, which means the cancer has spread to other parts of the body. This study will see if using specific blood tests, called serum tumor markers, to determine when to order scans is just as effective as the usual monitoring methods. Participants in this trial will receive either the new approach or the standard care to see which works better in tracking the progress of their cancer.
To be eligible for this trial, patients must have a confirmed diagnosis of hormone receptor-positive, HER2-negative metastatic breast cancer and be starting their first treatment for it. They should also have certain blood tests done that indicate their cancer is active. Participants will have regular blood tests and imaging to monitor their condition over the study period. It's important to note that the trial is currently recruiting patients, and those interested should discuss their eligibility and the study details with their healthcare provider.
Gender
ALL
Eligibility 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)
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Flint, Michigan, United States
Denver, Colorado, United States
Denver, Colorado, United States
Lone Tree, Colorado, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Burnsville, Minnesota, United States
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Bellingham, Washington, United States
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Seattle, Washington, United States
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Kennewick, Washington, United States
Sedro Woolley, Washington, United States
Kailua, Hawaii, United States
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Newberg, Oregon, United States
Littleton, Colorado, United States
New Ulm, Minnesota, United States
Pensacola, Florida, United States
Boise, Idaho, United States
Denver, Colorado, United States
Denver, Colorado, United States
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Saint Joseph, Michigan, United States
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Louisville, Kentucky, United States
Grand Junction, Colorado, United States
Torrington, Connecticut, United States
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Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Waterloo, Iowa, United States
Parker, Colorado, United States
Shreveport, Louisiana, United States
Niles, Michigan, United States
Joplin, Missouri, United States
Walla Walla, Washington, United States
Greenville, South Carolina, United States
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Atlanta, Georgia, United States
Grand Island, Nebraska, United States
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Fort Smith, Arkansas, United States
Santa Rosa, California, United States
Deerfield Beach, Florida, United States
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Post Falls, Idaho, United States
Bloomington, Illinois, United States
Pekin, Illinois, United States
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Egg Harbor Township, New Jersey, United States
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Saint George, Utah, United States
Poulsbo, Washington, United States
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Carmichael, California, United States
Muncie, Indiana, United States
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Hot Springs, Arkansas, United States
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Lihue, Hawaii, United States
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Meridian, Idaho, United States
Nampa, Idaho, United States
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Rolla, Missouri, United States
Rolla, Missouri, United States
Elmira, New York, United States
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Columbus, Ohio, United States
Portsmouth, Ohio, United States
Strongsville, Ohio, United States
Oregon City, Oregon, United States
Martinsville, Virginia, United States
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Burien, Washington, United States
Edmonds, Washington, United States
Everett, Washington, United States
Issaquah, Washington, United States
Lacey, Washington, United States
New Richmond, Wisconsin, United States
Sheboygan, Wisconsin, United States
Urbana, Illinois, United States
Springfield, Illinois, United States
Belpre, Ohio, United States
Columbus, Ohio, United States
Delaware, Ohio, United States
Longmont, Colorado, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Springfield, Ohio, United States
Anchorage, Alaska, United States
Caldwell, Idaho, United States
Coeur D'alene, Idaho, United States
Emmett, Idaho, United States
Meridian, Idaho, United States
Nampa, Idaho, United States
Sandpoint, Idaho, United States
Clive, Iowa, United States
West Des Moines, Iowa, United States
Garden City, Kansas, United States
Great Bend, Kansas, United States
Lenexa, Kansas, United States
Lenexa, Kansas, United States
Brighton, Michigan, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Canton, Michigan, United States
Caro, Michigan, United States
Chelsea, Michigan, United States
Chelsea, Michigan, United States
Clarkston, Michigan, United States
Clarkston, Michigan, United States
East China Township, Michigan, United States
Flint, Michigan, United States
Flint, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Livonia, Michigan, United States
Macomb, Michigan, United States
Macomb, Michigan, United States
Marlette, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Rochester Hills, Michigan, United States
Saginaw, Michigan, United States
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Warren, Michigan, United States
Warren, Michigan, United States
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West Branch, Michigan, United States
Ypsilanti, Michigan, United States
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Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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Troy, Ohio, United States
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Denver, Colorado, United States
Norton Shores, Michigan, United States
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Las Vegas, Nevada, United States
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London, Kentucky, United States
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'Aiea, Hawaii, United States
Winchester, Massachusetts, United States
Ontario, California, United States
Trumbull, Connecticut, United States
Selinsgrove, Pennsylvania, United States
Caguas, , Puerto Rico
Pasadena, California, United States
Phoenix, Arizona, United States
Elk Grove, California, United States
Rocklin, California, United States
Sacramento, California, United States
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Santa Maria, California, United States
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Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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New York, New York, United States
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Waterbury, Connecticut, United States
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Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Cape May Court House, New Jersey, United States
Beavercreek, Ohio, United States
Clinton, South Carolina, United States
Stevens Point, Wisconsin, United States
Bayamon, , Puerto Rico
Manati, , Puerto Rico
Arroyo Grande, California, United States
Greenwich, Connecticut, United States
New Haven, Connecticut, United States
Springfield, Massachusetts, United States
Hazleton, Pennsylvania, United States
Bluffton, South Carolina, United States
Hilton Head Island, South Carolina, United States
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Stockton, California, United States
Honolulu, Hawaii, United States
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Washington, Missouri, United States
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Newport Beach, California, United States
Denver, Colorado, United States
Golden, Colorado, United States
Lafayette, Colorado, United States
Thornton, Colorado, United States
Honolulu, Hawaii, United States
Mooresville, Indiana, United States
Worthington, Minnesota, United States
Redmond, Oregon, United States
Burr Ridge, Illinois, United States
Chesapeake, Virginia, United States
'Aiea, Hawaii, United States
Denver, Colorado, United States
Fargo, North Dakota, United States
Aguadilla, , Puerto Rico
Arecibo, , Puerto Rico
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Ponce, , Puerto Rico
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Kingman, Arizona, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Santa Rosa, California, United States
Colorado Springs, Colorado, United States
Englewood, Colorado, United States
Lafayette, Indiana, United States
Peabody, Massachusetts, United States
Burnsville, Minnesota, United States
San Juan, , Puerto Rico
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Carmichael, California, United States
Stamford, Connecticut, United States
Savannah, Georgia, United States
'Aiea, Hawaii, United States
'Ewa Beach, Hawaii, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Shreveport, Louisiana, United States
Kalamazoo, Michigan, United States
Thief River Falls, Minnesota, United States
Dublin, Ohio, United States
Tamuning, , Guam
Glastonbury, Connecticut, United States
Melrose Park, Illinois, United States
Westerly, Rhode Island, United States
Homer Glen, Illinois, United States
Napa, California, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
'Aiea, Hawaii, United States
Lexington, Kentucky, United States
Bellevue, Washington, United States
Waterloo, Iowa, United States
Sheboygan, Wisconsin, United States
Des Moines, Iowa, United States
Mount Sterling, Kentucky, United States
Cameron Park, California, United States
Hastings, Nebraska, United States
Summit, New Jersey, United States
Sheboygan, Wisconsin, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Pittsburg, Kansas, United States
Centralia, Illinois, United States
Nags Head, North Carolina, United States
Paducah, Kentucky, United States
San Juan, , Puerto Rico
Danville, Illinois, United States
New Albany, Ohio, United States
Guilford, Connecticut, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Patients applied
Trial Officials
Melissa Accordino
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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