Conditions postmenopausal women, locally advanced metastatic breast cancer, metastatic breast cancer
Treatment everolimus + letrozole
Phase phase 4
Sponsor Novartis Pharmaceuticals
Start date August 2011
End date December 2016
Trial size 70 participants
Trial identifier NCT01231659, CRAD001JIL05


This is a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or Examestane.

There are no treatments specifically approved after recurrence or progression on AIs. Available options, based on common clinical practice and several treatment guidelines (e.g. NCCN treatment guidelines 2008), include fulvestrant.

Combining RAD001 with letrazole is a rational approach to the treatment of advanced Brest Cancer, offering the potential for inhibition of tumor cell growth\ proliferation and anti angiogenesis while at the same time potentially preventing the development of letrazole resistance.

Recruiting in the following locations…

United States No locations recruiting
Other countries Israel

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Everolimus 10 mg + Letrozole 2.5 mg
everolimus + letrozole RAD001

Primary Outcomes

Overall Response Rate (ORR)
time frame: until 1st progression

Secondary Outcomes

Progression Free Survival (PFS)
time frame: until 1st progression
Overall Survival (OS)
time frame: 3 years after LPLV
Disease Control Rate (DCR)
time frame: until disease progression
Characterize the safety profile
time frame: All study duration

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane. - Refractory disease to hormonal therapy is defined as: 1. Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane. 2. Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole. 3. Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer. Exclusion Criteria: - Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry. - Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry. - Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title Phase II Open Label Study of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic, Estrogen Receptor Positive Breast Cancer, After Failure of Tamoxifen and/or Anastrozole and/or Letrozole and/or Fulvestrant and/or Exemestane
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.