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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01231659
First Posted: November 1, 2010
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose

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 Metastatic Breast Cancer Metastatic Breast Cancer Drug: Everolimus + Letrozole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: until 1st progression ]
    imaging every 12 weeks


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: until 1st progression ]
    imaging every 12 weeks

  • Overall Survival (OS) [ Time Frame: 3 years after LPLV ]
    by phone call to the patient

  • Disease Control Rate (DCR) [ Time Frame: until disease progression ]
    imaging every 12 weeks

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


Enrollment: 73
Actual Study Start Date: August 9, 2011
Study Completion Date: April 30, 2017
Primary Completion Date: April 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus + Letrozole
Everolimus 10 mg + Letrozole 2.5 mg
Drug: Everolimus + Letrozole
Other Name: RAD001

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231659


Locations
Israel
Novartis Investigative Site
Jerusalem, Israel, 91120
Novartis Investigative Site
Kfar-Saba, Israel, 4428164
Novartis Investigative Site
Petach Tikva, Israel, 49100
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Novartis Investigative Site
Rehovot, Israel, 76100
Novartis Investigative Site
Tel Aviv, Israel, 62439
Novartis Investigative Site
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01231659     History of Changes
Other Study ID Numbers: CRAD001JIL05
First Submitted: October 28, 2010
First Posted: November 1, 2010
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Anastrozole
Everolimus
Sirolimus
Tamoxifen
Estrogens
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
Hormones
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators