Breast Cancer SWOG S1207

April 11, 2017

Sponsor: National Cancer Institute (NCI)

Number: SWOG S1207

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III trials are  new treatments that have worked well in a small number of patients with a this disease) studies how well giving hormone therapy together with or without Everolimus work in treating patients with breast cancer. High amounts of estrogen (primary female hormone) can cause the growth of breast cancer cells. Hormone therapy using certain treatments may fight breast cancer, by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hormone therapy is more effective when given with or without Everolimus in treating breast cancer.

Hormonal therapy medicines treat hormone-receptor-positive breast cancers in two ways:

1. by lowering the amount of the estrogen hormone in the body
2. by blocking the action of estrogen on breast cancer cells 

Who’s eligible: 

• Patients must have a histologically confirmed diagnosis of invasive breast carcinoma (cancer) with positive estrogen and/or progesterone receptor (receptors that may be found in breast cancer cells) status, and negative HER-2 (an oncogene, a gene that has the potential to cause cancer), for whom standard adjuvant endocrine therapy is planned (adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy to lower the chance of the cancer coming back). Estrogen and progesterone receptor positivity must be assessed according to American Society of Clinical Oncology (ASCO) )/College of American Pathologists (CAP) guidelines. HER-2 equivocal is not eligible.
• Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed:
  • Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
  • Multicentric disease is defined as more than one invasive cancer >= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
• This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center, and Hartford Hospital.