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Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 28, 2010
Last updated: July 25, 2016
Last verified: July 2016

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.

Condition Intervention Phase
Postmenopausal Women,
Locally Advanced or Metastatic Breast Cancer
Drug: Everolimus + Letrozole
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: until 1st progression ] [ Designated as safety issue: No ]
    imaging every 12 weeks

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: until 1st progression ] [ Designated as safety issue: No ]
    imaging every 12 weeks

  • Overall Survival (OS) [ Time Frame: 3 years after LPLV ] [ Designated as safety issue: No ]
    by phone call to the patient

  • Disease Control Rate (DCR) [ Time Frame: until disease progression ] [ Designated as safety issue: No ]
    imaging every 12 weeks

  • Characterize the safety profile [ Time Frame: All study duration ] [ Designated as safety issue: Yes ]
    Adverse Events Serious Adverse Events, abs, ECG

Enrollment: 73
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Arms Assigned Interventions
Experimental: Everolimus + Letrozole
Everolimus 10 mg + Letrozole 2.5 mg
Drug: Everolimus + Letrozole
Other Name: RAD001


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01231659

Novartis Investigative Site
Jerusalem, Israel, 9112001
Novartis Investigative Site
Kfar-Saba, Israel, 4428164
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 5266202
Novartis Investigative Site
Rehovot, Israel, 76100
Novartis Investigative Site
Tel-Aviv, Israel, 6423906
Novartis Investigative Site
Zrifin, Israel, 70300
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01231659     History of Changes
Other Study ID Numbers: CRAD001JIL05 
Study First Received: October 28, 2010
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Novartis:
RAD001 (Everolimus)
Breast cancer
Metastatic Breast cancer
Estrogen receptor positive
Failure of Tamoxifen
Anastrozole or Examestane

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators processed this record on October 21, 2016