Research & Trial Information
Protocol#: SWOG – S1703
Cancer Type: Breast Metastatic
- 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.
- Patients (women and men) must be ≥ 18 years of age.
Patients must have been tested for all of 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: CA 15-3, CA 27.29 and CEA
Patients must have systemic radiographic imaging prior to initiation of systemic therapy for treatment of metastatic breast cancer and prior to Step 1 registration with either:
• a computed tomography (CT) scan of the chest and abdomen with or without CT pelvis, and with or without bone scan
• a positron emission tomography (PET) scan with or without CT
- 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 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.
- Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five
- Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current treatment regimen initiated no more than 28 days prior to registration.
- Patients must be registered to Step 2 randomization between 56 days and 112 days after the initiation of first-line systemic therapy for metastatic disease. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization.