Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Completed · Phase 2

Conditions studied: Hormone Receptor Positive Breast Cancer

In brief

The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.

Key facts

Study ID

NCT01698918

Run by

Novartis Pharmaceuticals

People needed

202

Starts

2013-03-07

Expected to finish

2021-01-13

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
• Histological or cytological confirmation of ER+/ HER2- breast cancer
• Postmenopausal women
• No prior treatment for metastatic breast cancer

You may not qualify if…

• Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
• Patients who had received prior hormonal or any other systemic therapy for metastatic breast cancer. Patients might have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
• Previous treatment with mTOR inhibitors.
• Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
• Other protocol-defined inclusion/exclusion criteria might apply

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Loma Linda University Loma Linda — Loma Linda, California, United States
• Breastlink Medical Group Dept. of BreastlinkResearchGrp — Long Beach, California, United States
• Oncology Specialists, SC Advocate Medical Group-Niles — Park Ridge, Illinois, United States
• St. Francis Health Comprehensive Cancer Center — Topeka, Kansas, United States
• Norton Healthcare Inc SC — Louisville, Kentucky, United States
• Baystate Medical Center SC-2 — Springfield, Massachusetts, United States
• Saint Barnabas Medical Center CancerCenter of Saint Barnabas — Livingston, New Jersey, United States
• University of New Mexico Hospital SC — Albuquerque, New Mexico, United States
• Broome Oncology SC — Johnson City, New York, United States
• Columbia University Medical Center- New York Presbyterian Columbia — New York, New York, United States
• Cone Health Cancer Center — Greensboro, North Carolina, United States
• East Texas Hematology Clinic SC — Lufkin, Texas, United States
• Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) — Salt Lake City, Utah, United States
• Novartis Investigative Site — Santa Rosa, La Pampa Province, Argentina
• Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Besançon, France
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Hyères, France
• Novartis Investigative Site — Le Chesnay, France
• Novartis Investigative Site — Lyon, France
• University of Alabama Comprehensive Cancer Center SC-2 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.