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Protocol No. S1207

Principal Investigator Burkard, Mark

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer

Objective The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone.

Treatment Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients. In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

Description This research study has two study treatment groups. One group will get the usual hormone treatment to treat their cancer plus a placebo (a pill with no medicine). The other group will get the usual hormone treatment plus a research drug called everolimus. A computer will randomly put you in one of these study groups. You have a 50/50 chance of being placed into either group. This is done because no one knows if one treatment is better than the other. Once you are put in one group, you cannot switch to the other group. Neither you nor your doctor can choose or know which group you will be in.

Key Eligibility Confirmed diagnosis of invasive breast cancer with positive estrogen and/or progesterone receptor status and negative HER-2, for whom standard adjuvant endocrine therapy is planned.

Patients must not have metastatic disease (Stage IV).

Patients must be high risk by belonging to one of the following risk groups:
  • Completion of adjuvant chemotherapy and pathology negative lymph nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Onctotype DX® Recurrence score > 25
  • Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and an Oncotype DX® Recurrence Score > 25
  • Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes independent of the Oncotype DX® Recurrence Score in the primary tumor.
  • Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy.

  • Patients must have completed surgery with negative margins and appropriate staging.

    Patients must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection.

    Patients must have completed standard neoadjuvent or adjuvant taxane and/or anthracycline based chemotherapy prior to randomization.

    Applicable Disease Sites Breast

    Therapies Involved Hormone Therapy; Immunotherapy

    Drugs Involved Everolimus; RAD001 (Everolimus); anastrozole; arimidex (anastrozole); aromasin (exemestane); exemestane; femara (letrozole); goserelin; letrozole; leuprolide acetate; lupron (leuprolide acetate); nolvadex (tamoxifen); placebo; tamoxifen; zoladex (goserelin)

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Bellin Memorial Hospital/Cancer Team at Bellin Health; Columbia St. Marys Hospital Milwaukee, Inc; Dean Health System, Hematology and Oncology Clinic ; Freeport Hospital, L.C Ferguson Cancer Center ; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Mercy Health Systems, Janesville ; St. Marys Hospital Ozaukee, Inc; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park