A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
BOLERO-6
A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.
2 other identifiers
interventional
309
18 countries
83
Brief Summary
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2013
Typical duration for phase_2 breast-cancer
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedStudy Start
First participant enrolled
February 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
February 1, 2021
5.3 years
January 11, 2013
April 29, 2019
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.
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 39 months
Secondary Outcomes (7)
Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone
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 39 months
Overall Survival (OS)
Every 3 months following end of treatment visit, assessed for approximately 54 months
Overall Response Rate (ORR)
From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
Clinical Benefit Rate (CBR)
From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months
Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration
Baseline, every 6 weeks up to about 43 months
- +2 more secondary outcomes
Study Arms (3)
Capecitabine 1250 mg/m2
EXPERIMENTALCapecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Everolimus 10 mg
EXPERIMENTALEverolimus (10 mg daily) (investigational arm).
Everolimus 10 mg + Exemestane 25 mg
ACTIVE COMPARATOREverolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).
Interventions
Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied)
Exemestane, tablets for oral use, 25 mg per day in (locally supplied)
Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)
Eligibility Criteria
You may qualify if:
- \- Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
You may not qualify if:
- \- Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
University of California at Los Angeles Mattel Children's Hospital
Los Angeles, California, 90095, United States
Sharp Memorial Hospital SharpClinicalOncologyResearch
San Diego, California, 92123, United States
Florida Cancer Specialists Dept of Oncology (2)
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists FL Cancer Specialists
Fort Myers, Florida, 33901, United States
Lahey Clinic Dept of Lahey Clinic (2)
Burlington, Massachusetts, 01805, United States
New England Hematology/ Oncology Associates, P.C. SC
Newton, Massachusetts, 02462, United States
Glacier View Research Institute - Cancer SC
Kalispell, Montana, 59901, United States
Trinitas Comprehensive Cancer Center SC
Elizabeth, New Jersey, 07207, United States
Hackensack University Medical Center Dept of Oncology
Hackensack, New Jersey, 07601, United States
Rutgers-New Jersey Medical School SC
Newark, New Jersey, 07101, United States
Oncology Hematology Care Inc Oncology Hematology Care 2
Cincinnati, Ohio, 45242, United States
Oklahoma Cancer Specialists and Research Institute Oklahoma Cancer Specialists
Tulsa, Oklahoma, 74136, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, 37404, United States
The Jones Clinic SC
Germantown, Tennessee, 38138, United States
University of Tennessee SC
Knoxville, Tennessee, 27920-6969, United States
Sarah Cannon Research Institute SC (2)
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD
Fort Worth, Texas, 76104, United States
University of Virginia Health Systems SC-4
Charlottesville, Virginia, 22908-0334, United States
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, 98405, United States
Novartis Investigative Site
CABA, Buenos Aires, C1025ABI, Argentina
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Posadas, Misiones Province, Argentina
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Rosario, Santa Fe Province, S2000KZE, Argentina
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Rio Negro, Viedma, 8500, Argentina
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Córdoba, X5016KEH, Argentina
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Randwick, New South Wales, 2031, Australia
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Wahroonga, New South Wales, 2076, Australia
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Malvern, Victoria, 3144, Australia
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Parkville, Victoria, 3050, Australia
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Liège, 4000, Belgium
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Salvador, Estado de Bahia, 41253-190, Brazil
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Natal, Rio Grande do Norte, 59075 740, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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São Paulo, São Paulo, 01317-002, Brazil
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Aarhus, 8000 C, Denmark
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Copenhagen, DK-2100, Denmark
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Næstved, DK-4700, Denmark
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Odense C, DK 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Budapest, HUN, 1145, Hungary
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Debrecen, 4032, Hungary
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Tatabánya, 2800, Hungary
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Hyderabad, Andhra Pradesh, 500 034, India
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Pune, Maharashtra, 411013, India
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Kolkata, West Bengal, 700 053, India
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Mumbai, 400 012, India
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Limerick, Co Limerick, Ireland
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Dublin, D04 T6F, Ireland
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Galway, Ireland
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Beirut, 1107 2020, Lebanon
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Beirut, Lebanon
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El Achrafiyé, 166830, Lebanon
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Hazmiyeh, 470, Lebanon
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Saida, 652, Lebanon
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Kota Kinabalu, Sabah, 88586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Jesus Maria, Lima region, 11, Peru
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San Borja, Lima region, 41, Peru
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Surquillo, Lima region, 34, Peru
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Arequipa, Peru
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Arkhangelsk, 163045, Russia
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Moscow, 115478, Russia
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Saint Petersburg, 197758, Russia
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Seville, Andalusia, 41013, Spain
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Barcelona, Catalonia, 08035, Spain
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Madrid, 28033, Spain
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Madrid, 28040, Spain
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Eskilstuna, SE-631 88, Sweden
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Jönköping, 551 85, Sweden
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Stockholm, SE-171 76, Sweden
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Uppsala, SE-751 85, Sweden
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Vaxjo, SE-351 85, Sweden
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Västerås, 721 89, Sweden
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Lopburi, Changwat Lop Buri, 15000, Thailand
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Songkhla, Hat Yai, 90110, Thailand
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Muang, 40002, Thailand
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Adana, 01330, Turkey (Türkiye)
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Istanbul, 34303, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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East Kilbride, G75 8RG, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
Novartis Investigative Site
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Jerusalem G, de Boer RH, Hurvitz S, Yardley DA, Kovalenko E, Ejlertsen B, Blau S, Ozguroglu M, Landherr L, Ewertz M, Taran T, Fan J, Noel-Baron F, Louveau AL, Burris H. Everolimus Plus Exemestane vs Everolimus or Capecitabine Monotherapy for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer: The BOLERO-6 Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1367-1374. doi: 10.1001/jamaoncol.2018.2262.
PMID: 29862411DERIVED
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 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
February 5, 2013
Study Start
February 26, 2013
Primary Completion
July 2, 2018
Study Completion
July 30, 2018
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com