Research & Trial Information

SCHEMA S1703

Protocol#: SWOG – S1703

Cancer Type: Breast Metastatic

Patient Eligibility:

1. 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.
2. Patients (women and men) must be ≥ 18 years of age.

3. 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

4. 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

   or

   • a positron emission tomography (PET) scan with or without CT

5. Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels.
6. Patients with known brain metastases are not eligible as they may require regular radiographic monitoring to assess treatment response.
7. 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.
8. 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
9. 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.
10. 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.

Research & Trial Information

SCHEMA NRG BR004

Protocol#: NRG-BR004

Cancer Type: Breast Metastatic

Patient Eligibility:

1. The trial is open to female and male patients.
2. Patients must be ≥ 18 years old.
3. Patient must have an ECOG Performance Status of 0 or 1.
4. Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease.• De novo metastatic disease presenting without prior history of HER2-positive breast cancer:

   − Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient.

   • Locally recurrent or metastatic disease following prior therapy for early breast cancer:

   − Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease.

   − There must be an interval of ≥ 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy.

5. Patients must have measurable disease based on RECIST 1.1, as determined by the site, to be eligible.
6. The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing.
7. The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status. Patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant.
8. The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for ER and PgR according to current ASCO/CAP Guideline Recommendations for hormone receptor testing (http://www.asco.org). Patients with < 1% ER and PgR staining by IHC will be classified as negative. If sufficient material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility.
9. Localized palliative radiation therapy is allowed for symptom management if completed ≥ 14 days prior to randomization.
10. Patients must have imaging of the chest/abdomen/pelvis, preferably with a CT scan, and a bone scan within 4 weeks prior to randomization.
11. MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease. Neuroimaging is recommended but not required in asymptomatic patients.
12. LVEF assessment must be performed within 6 weeks prior to randomization.
13. No asymptomatic untreated CNS disease.
14. Known leptomeningeal carcinomatosis.
15. Patients with metastatic disease limited to the CNS.
16. History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for MBC with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases.
17. History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent.
18. Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease.

Research & Trial Information

SCHEMA A171601

Protocol#: Alliance – A171601

Cancer Type:  Breast Metastatic Age 70 and Older/Cancer Control

Patient Eligibility:

1. Documentation of Disease: Estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer. Histologic confirmation is required.
2. Measurable disease or non-measurable disease.
3. Planning to begin palbociclib for metastatic disease. One prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed. Patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration.
4. No prior therapy with a CDK inhibitor.
5. No untreated brain metastases. Patients with treated brain metastases must have completed treatment with steroids to be eligible.
6. No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ. However, patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for ≥ 3 years.
7. No active infection requiring treatment with antibiotics.
8. Patients must be able to swallow and retain oral medication.
9. Patient Age: ≥ 70 years.
10. ECOG Performance Status 0, 1 or 2.