Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

NCT ID: NCT00863655

Last Updated: 2017-05-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

724 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-03

Study Completion Date

2014-12-04

Brief Summary

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There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Everolimus + Exemestane

Everolimus 10 mg daily in combination with exemestane 25 mg daily

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Exemestane

Intervention Type DRUG

Exemestane 25 mg orally daily.

Placebo + Exemestane

Placebo of everolimus in combination with exemestane 25 mg daily

Group Type ACTIVE_COMPARATOR

Exemestane

Intervention Type DRUG

Exemestane 25 mg orally daily.

Everolimus Placebo

Intervention Type DRUG

Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Interventions

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Everolimus

Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Intervention Type DRUG

Exemestane

Exemestane 25 mg orally daily.

Intervention Type DRUG

Everolimus Placebo

Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Intervention Type DRUG

Other Intervention Names

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RAD001

Eligibility Criteria

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Inclusion Criteria

* Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women.
* Disease refractory to non steroidal aromatase inhibitors (NSAI),
* Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
* Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.

Exclusion Criteria

* HER2-overexpressing patients
* Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
* Patients who received more than one chemotherapy line for Advanced Breast Cancer.
* Previous treatment with exemestane or mTOR inhibitors.
* Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
* Radiotherapy within four weeks prior to randomization
* Currently receiving hormone replacement therapy,
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Site Status

Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

Fayetteville, Arkansas, United States

Site Status

Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

Anaheim, California, United States

Site Status

Comprehensive Blood and Cancer Center Dept. of CBCC (3)

Bakersfield, California, United States

Site Status

Cancer Care Associates Dept.ofCancerCareAssoc. (2)

Fresno, California, United States

Site Status

Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc

Grass Valley, California, United States

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Scripps Clinic SC

La Jolla, California, United States

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The Angeles Clinic and Research Institute

Los Angeles, California, United States

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USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

Los Angeles, California, United States

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Sharp Memorial Hospital SharpClinicalOncologyResearch

San Diego, California, United States

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University of California San Francisco UCSF Medical Center

San Francisco, California, United States

Site Status

Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ

Santa Monica, California, United States

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St Joseph Heritage Healthcare Dept. of RRMG (4)

Santa Rosa, California, United States

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Comprehensive Cancer Center - Boca Raton Deerfield Beach

Boca Raton, Florida, United States

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Florida Cancer Research Institute

Davie, Florida, United States

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Florida Cancer Specialists DeptofFloridaCancerSpecialists

Fort Myers, Florida, United States

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Memorial Hospital Memorial Cancer Institute

Hollywood, Florida, United States

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MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

Orlando, Florida, United States

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Palm Beach Cancer Institute

West Palm Beach, Florida, United States

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Florida Medical Clinic PA Dept.ofFloridaMedicalClinic

Zephyrhills, Florida, United States

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Georgia Cancer Specialists. Drug Ship

Decatur, Georgia, United States

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Rush University Medical Center Study Coordinator

Chicago, Illinois, United States

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Oncology Specialists, SC Dept.of Oncology Specialists

Park Ridge, Illinois, United States

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Hematology Oncology of Indiana

Indianapolis, Indiana, United States

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Horizon Oncology Center

Lafayette, Indiana, United States

Site Status

Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

Wichita, Kansas, United States

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University of Louisville / James Graham Brown Cancer Center SC

Louisville, Kentucky, United States

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Hematology Oncology Clinic Hematology Oncology Clinic (2)

Baton Rouge, Louisiana, United States

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Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2

Metairie, Louisiana, United States

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Anne Arundel Health System Research Institute Wayson Pavilion

Annapolis, Maryland, United States

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Mercy Medical Center Medical Oncology & Hematology

Baltimore, Maryland, United States

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Weinberg Cancer Institute at Franklin Square Hospital

Baltimore, Maryland, United States

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Maryland Hematology/Oncology Associates, P.A.

Baltimore, Maryland, United States

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Frederick Memorial Hospital Dept. of FMH-IRB

Frederick, Maryland, United States

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Holy Cross Hospital Holy Cross

Silver Spring, Maryland, United States

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Lahey Clinic Dept of Lahey Clinic (2)

Burlington, Massachusetts, United States

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Fairview Southdale Medical Oncology Clinic

Edina, Minnesota, United States

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St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast

St Louis, Missouri, United States

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Southeast Nebraska Oncology Cancer Center

Lincoln, Nebraska, United States

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Regional Cancer Care Associates Dept. of the CCHD

Cherry Hill, New Jersey, United States

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Trinitas Comprehensive Cancer Center Dept. of Trinitas

Elizabeth, New Jersey, United States

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University of New Mexico Cancer Research Center Dept of UNM Cancer & Research

Albuquerque, New Mexico, United States

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Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

Lake Success, New York, United States

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ProHealth Care

Lake Success, New York, United States

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Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

New York, New York, United States

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Weill Cornell Medical College Weill Cornell Med. Ctr.

New York, New York, United States

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Hematology Oncology Association of Rockland

Nyack, New York, United States

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Marion L. Shepard Cancer Center

Washington, North Carolina, United States

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Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma

Lawton, Oklahoma, United States

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Cancer Care Associates SC

Tulsa, Oklahoma, United States

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Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)

Hershey, Pennsylvania, United States

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Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr

Charleston, South Carolina, United States

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Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

Nashville, Tennessee, United States

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University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.

Dallas, Texas, United States

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The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

Fort Worth, Texas, United States

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University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)

Houston, Texas, United States

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Hope Oncology HOPE Richardson

Richardson, Texas, United States

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Northern Utah Cancer Associates SC

Ogden, Utah, United States

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Central Utah Clinic CRAD001Y2301

Provo, Utah, United States

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Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)

Salt Lake City, Utah, United States

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University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)

Salt Lake City, Utah, United States

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Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA

Reston, Virginia, United States

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University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)

Madison, Wisconsin, United States

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Novartis Investigative Site

Nambour, Queensland, Australia

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Redcliffe, Queensland, Australia

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Bedford Park, South Australia, Australia

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Parkville, Victoria, Australia

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Parkville, Victoria, Australia

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Subiaco, Western Australia, Australia

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Innsbruck, Austria, Austria

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Wels, Austria, Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Sint-Niklaas, , Belgium

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Wilrijk, , Belgium

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Salvador, Estado de Bahia, Brazil

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Uberlândia, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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St. Catharines, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Brno, Czech Republic, Czechia

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Prague, Czech Republic, Czechia

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Olomouc, CZE, Czechia

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Menoufiya, Egypt, Egypt

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Alexandria, , Egypt

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Cairo, , Egypt

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La Roche-sur-Yon, , France

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Le Mans, , France

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Lyon, , France

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Marseille, , France

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Paris, , France

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Rouen, , France

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Rouen, , France

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Saint-Herblain Cédex, , France

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Saint-Nazaire, , France

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Berlin, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Mannheim, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Trier, , Germany

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Hong Kong SAR, , Hong Kong

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Budapest, , Hungary

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Szeged, , Hungary

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Szolnok, , Hungary

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Brindisi, BR, Italy

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Catania, CT, Italy

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Antella - Bagno A Ripoli, FI, Italy

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Genova, GE, Italy

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Macerata, MC, Italy

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Perugia, PG, Italy

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Torino, TO, Italy

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Terni, TR, Italy

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Saronno, Va, Italy

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Varese, VA, Italy

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Nagoya, Aichi-ken, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Kagoshima, Kagoshima-ken, Japan

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Isehara, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Hidaka, Saitama, Japan

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Kitaadachi-gun, Saitama, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Koto, Tokyo, Japan

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Eindhoven, Netherlands, Netherlands

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Alkmaar, , Netherlands

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Amsterdam, , Netherlands

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Dordrecht, , Netherlands

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Sittard-Geleen, , Netherlands

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The Hague, , Netherlands

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Christchurch, Christchurch, New Zealand

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Lørenskog, , Norway

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Krakow, , Poland

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Rzeszów, , Poland

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Warsaw, , Poland

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Hwasun-gun, Jeollanam-do, South Korea

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Mallorca, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, Catalonia, Spain

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Lleida, Catalonia, Spain

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Terrassa, Catalonia, Spain

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A Coruña, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Stockholm, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Songkhla, , Thailand

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Izmir, Turkey, Turkey (Türkiye)

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Altunizade, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Broomfield, Chelmsford, United Kingdom

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Truro, Cornwall, United Kingdom

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Cardiff, , United Kingdom

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Nottingham, , United Kingdom

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Sheffield, , United Kingdom

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Southampton, , United Kingdom

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Countries

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United States Australia Austria Belgium Brazil Canada Czechia Egypt France Germany Hong Kong Hungary Italy Japan Netherlands New Zealand Norway Poland South Korea Spain Sweden Thailand Turkey (Türkiye) United Kingdom

References

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Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

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Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Voi M, Gnant M, Hortobagyi G, Baselga J, Moynahan ME. Prevalence of ESR1 Mutations in Cell-Free DNA and Outcomes in Metastatic Breast Cancer: A Secondary Analysis of the BOLERO-2 Clinical Trial. JAMA Oncol. 2016 Oct 1;2(10):1310-1315. doi: 10.1001/jamaoncol.2016.1279.

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Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA 3rd, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, Shtivelband M, Masuda N, Dakhil S, Anderson I, Robinson DM, He W, Garg A, McDonald ER 3rd, Bitter H, Huang A, Taran T, Bachelot T, Lebrun F, Lebwohl D, Baselga J. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016 Feb 10;34(5):419-26. doi: 10.1200/JCO.2014.60.1971. Epub 2015 Oct 26.

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PMID: 26503204 (View on PubMed)

Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA 3rd, Provencher L, Neven P, Gnant M, Shtivelband M, Wu C, Fan J, Feng W, Taran T, Baselga J. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2dagger. Ann Oncol. 2014 Dec;25(12):2357-2362. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

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PMID: 25231953 (View on PubMed)

Rugo HS, Pritchard KI, Gnant M, Noguchi S, Piccart M, Hortobagyi G, Baselga J, Perez A, Geberth M, Csoszi T, Chouinard E, Srimuninnimit V, Puttawibul P, Eakle J, Feng W, Bauly H, El-Hashimy M, Taran T, Burris HA 3rd. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol. 2014 Apr;25(4):808-815. doi: 10.1093/annonc/mdu009. Epub 2014 Mar 10.

Reference Type DERIVED
PMID: 24615500 (View on PubMed)

Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25.

Reference Type DERIVED
PMID: 24158787 (View on PubMed)

Campone M, Beck JT, Gnant M, Neven P, Pritchard KI, Bachelot T, Provencher L, Rugo HS, Piccart M, Hortobagyi GN, Nunzi M, Heng DY, Baselga J, Komorowski A, Noguchi S, Horiguchi J, Bennett L, Ziemiecki R, Zhang J, Cahana A, Taran T, Sahmoud T, Burris HA 3rd. Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy. Curr Med Res Opin. 2013 Nov;29(11):1463-73. doi: 10.1185/03007995.2013.836078. Epub 2013 Sep 4.

Reference Type DERIVED
PMID: 23962028 (View on PubMed)

Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer. 2014 Nov;21(6):703-14. doi: 10.1007/s12282-013-0444-8. Epub 2013 Feb 13.

Reference Type DERIVED
PMID: 23404211 (View on PubMed)

Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

Reference Type DERIVED
PMID: 22149876 (View on PubMed)

Other Identifiers

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2008-008698-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001Y2301

Identifier Type: -

Identifier Source: org_study_id

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