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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overPharmaceutical / IndustryCRAD001Y24135
2012-003065-17, NCT01698918

Trial Description

Summary

The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted only in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis PharmaceuticalsStudy Director

Novartis PharmaceuticalsPh: 1-888-669-6682

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Alfreda Lewis Ph: 205-978-2848
  Email: alfreda.lewis@ccc.uab.edu
 Andres Forero-TorresPrincipal Investigator
Arizona
  Gilbert
 Banner MD Anderson Cancer Center
 Shana Clark Ph: *see departments*
  Email: shannon.johnson2@bannerhealth.com
 Mary CianfroccaPrincipal Investigator
California
  Loma Linda
 Loma Linda University Loma Linda
 Lorena Garcia Ph: 909-558-4050
  Email: lcgarcia@llu.edu
 Yuan YuanPrincipal Investigator
  Long Beach
 Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
 Andrea Provost Ph: +1 562 981 6101 ext 115
  Email: Andrea.provost@breastlink.com
 John S. LinkPrincipal Investigator
Illinois
  Park Ridge
 Oncology Specialists, SC at Lutheran General Advanced Care Center
 Milenna Undda Ph: 847-410-0660
  Email: mundda@oncmed.net
 Sigrun HallmeyerPrincipal Investigator
Kentucky
  Louisville
 Norton Cancer Institute
 Juli Brown Ph: 502-629-5315
  Email: juli.brown@nortonhealthcare.org
 Janell SeegerPrincipal Investigator
Maryland
  Silver Spring
 Holy Cross Hospital
 Shebna Garcon
  Email: garconsm@holycrosshealth.org
 Cheryl A. AylesworthPrincipal Investigator
Missouri
  Manchester
 Mercy Medical Research Institute
 Pearlena Hamlet Ph: 417-820-8099
  Email: pearlena.hamlet@mercy.net
 Viran R. HoldenPrincipal Investigator
Nebraska
  Omaha
 Nebraska Methodist Hospital SC-1
 Ann Burch
  Email: ann.burch@alegent.org
 Margaret Barbara BlockPrincipal Investigator
New Jersey
  Livingston
 St. Barnabas Medical Center Cancer Center
 Kathy Bryckta Ph: 973-322-2470
  Email: kbrychta@barnabashealth.org
 Richard A. MichaelsonPrincipal Investigator
New Mexico
  Albuquerque
 University of New Mexico Hospital SC
 Emily Lytle Ph: 505-925-0416
  Email: Emily.lytle@nmcancercare.com
 Melanie RoycePrincipal Investigator
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Lois Brafman Ph: 212-304-5579
  Email: mk3007@columbia.edu
 Matthew A. MaurerPrincipal Investigator
North Carolina
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Chantay Witcher Ph: +1 336 832 0836
  Email: chantay.witcher@conehealth.com
 James Mitchell GranfortunaPrincipal Investigator
Texas
  Lufkin
 East Texas Hematology & Oncology Clinic, PA
 Kavitha Pinnamaneni
  Email: kavithapinnamaneni@yahoo.com
 Kavitha PinnamaneniPrincipal Investigator
Utah
  Salt Lake City
 Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
 Bianca McGraw Ph: 801-281-6864
  Email: bmcgraw@utahcancer.com
 W. Graydon HarkerPrincipal Investigator
France
  Besançon cedex
 Novartis Investigative Site
  Bordeaux
 Novartis Investigative Site
  Brest
 Novartis Investigative Site
  Le Chesnay
 Novartis Investigative Site
  Lyon Cedex
 Novartis Investigative Site
  Nancy
 Novartis Investigative Site
  Nantes cedex 2
 Novartis Investigative Site
Hungary
  Gyula
 Novartis Investigative Site
Japan
  Kawasaki-city
 Novartis Investigative Site
  Kumamoto City
 Novartis Investigative Site
  Nagoya-city
 Novartis Investigative Site
  Sapporo
 Novartis Investigative Site
Iwate
  Morioka-city
 Novartis Investigative Site
Netherlands
  Maastricht
 Novartis Investigative Site
Portugal
  Lisboa
 Novartis Investigative Site
Republic of Korea
  Seoul
 Novartis Investigative Site
Spain
  La Coruna
 Novartis Investigative Site
  Sabadell
 Novartis Investigative Site
  Salamanca
 Novartis Investigative Site
  Valencia
 Novartis Investigative Site
Thailand
  Bangkok
 Novartis Investigative Site
Turkey
  Altunizade
 Novartis Investigative Site
  Antalya
 Novartis Investigative Site
  Istanbul
 Novartis Investigative Site
  Izmir
 Novartis Investigative Site
United Kingdom
  Bath
 Novartis Investigative Site
  Norwich
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01698918
ClinicalTrials.gov processed this data on May 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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