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
BOLERO-2
A Randomized Double-Blind, Placebo-Controlled Study of 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
2 other identifiers
interventional
724
23 countries
195
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jun 2009
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedStudy Start
First participant enrolled
June 3, 2009
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2014
CompletedMay 2, 2017
March 1, 2017
5.5 years
March 16, 2009
July 31, 2012
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.
Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.
date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months
Secondary Outcomes (11)
Overall Survival (OS) by Number of Deaths
up to 53 months
Overall Survival (OS) by Median
up to 53 months
Overall Response Rate (ORR)
up to 21 months
Clinical Benefit Rate (CBR)
up to 21 months
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier
2, 4, 6, 9 months
- +6 more secondary outcomes
Study Arms (2)
Everolimus + Exemestane
EXPERIMENTALEverolimus 10 mg daily in combination with exemestane 25 mg daily
Placebo + Exemestane
ACTIVE COMPARATORPlacebo of everolimus in combination with exemestane 25 mg daily
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (200)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, 72703, United States
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim, California, 92807, United States
Comprehensive Blood and Cancer Center Dept. of CBCC (3)
Bakersfield, California, 93309, United States
Cancer Care Associates Dept.ofCancerCareAssoc. (2)
Fresno, California, 93720, United States
Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc
Grass Valley, California, 95945, United States
Scripps Clinic SC
La Jolla, California, 92121, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, 90053, United States
Sharp Memorial Hospital SharpClinicalOncologyResearch
San Diego, California, 92123, United States
University of California San Francisco UCSF Medical Center
San Francisco, California, 94101, United States
Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ
Santa Monica, California, 90404, United States
St Joseph Heritage Healthcare Dept. of RRMG (4)
Santa Rosa, California, 94503, United States
Comprehensive Cancer Center - Boca Raton Deerfield Beach
Boca Raton, Florida, 33248, United States
Florida Cancer Research Institute
Davie, Florida, 33328, United States
Florida Cancer Specialists DeptofFloridaCancerSpecialists
Fort Myers, Florida, 33901, United States
Memorial Hospital Memorial Cancer Institute
Hollywood, Florida, 33021, United States
MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)
Orlando, Florida, 32806, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Florida Medical Clinic PA Dept.ofFloridaMedicalClinic
Zephyrhills, Florida, 33542, United States
Georgia Cancer Specialists. Drug Ship
Decatur, Georgia, 30033, United States
Rush University Medical Center Study Coordinator
Chicago, Illinois, 60612, United States
Oncology Specialists, SC Dept.of Oncology Specialists
Park Ridge, Illinois, 60068-0736, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
Wichita, Kansas, 67214-3728, United States
University of Louisville / James Graham Brown Cancer Center SC
Louisville, Kentucky, 40202, United States
Hematology Oncology Clinic Hematology Oncology Clinic (2)
Baton Rouge, Louisiana, 70808, United States
Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2
Metairie, Louisiana, 70006, United States
Anne Arundel Health System Research Institute Wayson Pavilion
Annapolis, Maryland, 21401, United States
Mercy Medical Center Medical Oncology & Hematology
Baltimore, Maryland, 21202, United States
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore, Maryland, 21237-3998, United States
Maryland Hematology/Oncology Associates, P.A.
Baltimore, Maryland, 21237, United States
Frederick Memorial Hospital Dept. of FMH-IRB
Frederick, Maryland, 21701, United States
Holy Cross Hospital Holy Cross
Silver Spring, Maryland, 20910, United States
Lahey Clinic Dept of Lahey Clinic (2)
Burlington, Massachusetts, 01805, United States
Fairview Southdale Medical Oncology Clinic
Edina, Minnesota, 55435, United States
St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast
St Louis, Missouri, 63141, United States
Southeast Nebraska Oncology Cancer Center
Lincoln, Nebraska, 68510, United States
Regional Cancer Care Associates Dept. of the CCHD
Cherry Hill, New Jersey, 08003, United States
Trinitas Comprehensive Cancer Center Dept. of Trinitas
Elizabeth, New Jersey, 07207, United States
University of New Mexico Cancer Research Center Dept of UNM Cancer & Research
Albuquerque, New Mexico, 87131, United States
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
Lake Success, New York, 11042, United States
ProHealth Care
Lake Success, New York, 11042, United States
Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)
New York, New York, 10003, United States
Weill Cornell Medical College Weill Cornell Med. Ctr.
New York, New York, 10021, United States
Hematology Oncology Association of Rockland
Nyack, New York, 10960, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889, United States
Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma
Lawton, Oklahoma, 73505, United States
Cancer Care Associates SC
Tulsa, Oklahoma, 74136, United States
Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)
Hershey, Pennsylvania, 17033-0850, United States
Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr
Charleston, South Carolina, 29425, United States
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.
Dallas, Texas, 75390-8852, United States
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
Fort Worth, Texas, 76104, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)
Houston, Texas, 77030-4009, United States
Hope Oncology HOPE Richardson
Richardson, Texas, 75080, United States
Northern Utah Cancer Associates SC
Ogden, Utah, 84403-3105, United States
Central Utah Clinic CRAD001Y2301
Provo, Utah, 84604, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)
Salt Lake City, Utah, 84106, United States
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)
Salt Lake City, Utah, 84112, United States
Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA
Reston, Virginia, 20190, United States
University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)
Madison, Wisconsin, 53792, United States
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Related Publications (9)
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.
PMID: 29522361DERIVEDChandarlapaty 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.
PMID: 27532364DERIVEDHortobagyi 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.
PMID: 26503204DERIVEDPiccart 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.
PMID: 25231953DERIVEDRugo 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.
PMID: 24615500DERIVEDYardley 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.
PMID: 24158787DERIVEDCampone 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.
PMID: 23962028DERIVEDNoguchi 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.
PMID: 23404211DERIVEDBaselga 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.
PMID: 22149876DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 18, 2009
Study Start
June 3, 2009
Primary Completion
December 4, 2014
Study Completion
December 4, 2014
Last Updated
May 2, 2017
Results First Posted
August 31, 2012
Record last verified: 2017-03