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An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Hormone Receptor Positive Breast Cancer

Thank you

Trial Information

An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer

Inclusion Criteria:

- Patients 18 years old or greater

- Patients with metastatic or locally advanced, unresectable breast cancer not amenable
to curative treatment by surgery or radiotherapy

- Histological or cytological confirmation of estrogen-receptor positive (ER+) human
epidermal growth factor receptor 2 negative (HER2-) breast cancer

- Postmenopausal women

- No prior treatment for metastatic breast cancer

Exclusion Criteria:

- Patients with only non-measurable lesions other than bone metastases (e.g., pleural
effusion, ascites, etc)

- Patients who have received prior hormonal or any other systemic therapy for
metastatic breast cancer.

- Patients may 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 may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients progression-free after completion of 1st line treatment (everolimus + letrozole)

Outcome Description:

In this study Progression free survival is defined as the time from the date of receiving first line study treatment (everolimus + letrozole) to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last adequate tumor assessment.

Outcome Time Frame:

12 months after last patient recruited

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

February 2016

Related Keywords:

  • Hormone Receptor Positive Breast Cancer
  • metastatic breast cancer
  • Breast Neoplasms



Cone Health Cancer CenterGreensboro, North Carolina  
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)Salt Lake City, Utah  84103
Banner MD Anderson Cancer CenterGilbert, Arizona  85234
Saint Barnabas Medical Center CancerCenter of Saint BarnabasLivingston, New Jersey  07039
Mercy Medical Research Institute SCManchester, Missouri  63021
Oncology Specialists, SC Dept.of Oncology SpecialistsPark Ridge, Illinois  60068-0736
University of Alabama Comprehensive Cancer Center SCBirmingham, Alabama  35294
Loma Linda University Loma LindaLoma Linda, California  92354
Breastlink Medical Group Dept. of BreastlinkResearchGrpLong Beach, California  90806
Northwestern University SCChicago, Illinois  60611
Norton Healthcare, Inc. SCLouisville, Kentucky  40202
Holy Cross Hospital SCSilver Spring, Maryland  20910
Baystate Medical Center SCSpringfield, Massachusetts  00119
Methodist Cancer Center SC-1Omaha, Nebraska  68114
University of New Mexico Hospital SCAlbuquerque, New Mexico  87106
Columbia University Medical Center- New York Presbyterian ColumbiaNew York, New York  10032
Geisinger Health System GHSDanville, Pennsylvania  17822-2170
East Texas Hematology Clinic SCLufkin, Texas  75904
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SC-3Seattle, Washington  98109-1023