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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3)
Overall Recruitment Status: Active, currently enrolling
Official 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
Region Sponsors
National Cancer Institute (NCI)
Southwest Oncology Group
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase III
Study Population Description
Patients with Breast Cancer.
This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, 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 know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.
Detailed Description
The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer. Patients are stratified according to risk level (node-negative and recurrence score [RS] > 25 in the primary tumor, and a tumor measuring > or = 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS > 25 treated with adjuvant therapy vs > or = 4 positive lymph nodes [any RS value] treated with adjuvant therapy vs > or = 4 positive lymph nodes [any RS value] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms.
Gender Age Limit
Male & Female
Inclusion Criteria
  • Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
  • Patients must have a performance status of 0-2 by Zubrod criteria
  • Patients must be able to take oral medications
  • Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
  • Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
  • Peripheral granulocyte count > or = 1,500/mL
  • Hemoglobin > or = 9 g/dL
  • Platelet count > or = 100,000/mL
  • Bilirubin < or = 1.5 mg/dL (< or = 3.0 mg/dL if due to Gilbert syndrome)
Exclusion Criteria
  • Patients with known hepatitis
  • Uncontrolled diabetes - defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug
  • Any known uncontrolled, underlying pulmonary disease
  • Prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

Keywords and/or Specific Medical Conditions
  • Anastrozole
  • Immunologic Factors
  • Anti-Bacterial Agents
  • Immunosuppressive Agents
  • Antineoplastic Agents
  • Letrozole
  • Antineoplastic Agents, Hormonal
  • Leuprolide
  • Aromatase Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Bone Density Conservation Agents
  • Neoplasms
  • Breast Diseases
  • Neoplasms by Site
  • Breast Neoplasms
  • Pharmacologic Actions
  • Enzyme Inhibitors
  • Physiological Effects of Drugs
  • Estrogen Antagonists
  • Selective Estrogen Receptor Modulators
  • Estrogen Receptor Modulators
  • Sirolimus
  • Everolimus
  • Skin Diseases
  • Exemestane
  • Tamoxifen
  • Goserelin
  • Therapeutic Uses
  • Hormone Antagonists
  • Oncology (Adult)
  • Hormones, Hormone Substitutes, and Hormone Antagonists
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Alex R Menter, MD
Contact Information:
- Patricia L Bourie, RN
-Lone Tree Medical Offices - Lone Tree

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