Please Note: Below is partial eligibility, please contact GHCI Research Department for full eligibility requirements at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
Step 1 Registration:
- Patients must have a diagnosis of hormone receptor positive (ER+ and/or 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-nevo 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.
- Men or women at least 18 years of age.
- Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within 14 days initiation of first-line systemic treatment for metastatic disease: 1. CEA (must be tested. 2. CA 15-3 or CA27.29 (at least one of these must be tested).
- Patients must have systemic radiographic imaging at any time prior to initiation of systemic therapy or within 30 days after initiation of systemic therapy. Imaging must be done prior to Step 1 registration. Modality of imaging is at the discretion of the treating physician. Note: As this is a pragmatic trial, there is no limit on how long imaging may be done prior to Step 1 registration. Note: The treating physician may order additional imaging tests at any point prior to randomization at their discretion.
- 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.
- Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions: 1. Adequately treated basal (or squamous cell) skin cancer. 2. Any cancer from which the patient has been disease free for five years. 3. Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins.
Step 2 Registration:
- 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. 1. CEA (must be tested). 2. CA15-3 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 greater than or equal to 10% at the time of Step 2 registration.