Treatment trial for patients who have been diagnosed with high-risk, hormone receptor-positive and HER2/neu negative breast cancer

Study ID: S1207

Endocrine therapy for breast cancer patients with positive estrogen (ER) and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2. Patients must have completed adjuvant or neoadjuvant therapy.

To be eligible for this trial, you must have already completed adjuvant therapy (given in addition to primary therapy to make the therapy more effective) or neoadjuvant therapy (given just before primary therapy). The purpose of the trial is to determine whether taking the drug everolimus—in addition to adjuvant endocrine therapy—improves invasive disease-free survival.

You must have completed either breast-conserving surgery or total mastectomy with clear (negative) margins, meaning there are no cancer cells visible at the outer edges of where the tumor was removed. Additional operative procedures may be needed to produce clear margins. You must also have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection to determine if lymph nodes contain cancer.

Patient must be high-risk, e.g., completion of adjuvant chemotherapy with Oncotype score >25 for patients with either lymph nodes with tumor size of >2cm or positive one to three lymph nodes. No recurrence score needed for four or more + nodes (including in NAC). ER and/or PR positive Her2-negative invasive breast cancer. Completion of neoadjuvant chemotherapy and ≥1 + nodes pathologically determined after chemotherapy. Cancer can be multifocal, multicenteric, bilateral and inflammatory. Intervention treatment: Everolimus or placebo for 55 weeks plus five years of endocrine tx.

Additional schema information (PDF)

Inclusion Snapshot

  • Must have invasive breast cancer with positive estrogen and/or progesterone receptor, and negative HER2
  • Must be willing to take everolimus (10 mg daily) or receive placebo for 55 weeks
  • Must be willing to receive five years of endocrine therapy

Additional criteria may apply.

Contact Information

Lankenau Institute for Medical Research trial