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AzTrials

HER2/Neu Over-expressing Locally Advanced Breast CancerPhase 3BOLERO-3NCT01007942

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing everolimus, vinorelbine and trastuzumab in people with HER2/Neu Over-expressing Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 161 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
everolimus, vinorelbine and trastuzumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
569 participants
Where
161 sitesin 21 countries
Study dates
Oct 2009to Jun 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
  • HER2+ status defined as IHC 3+ staining or in situ hybridization positive
  • Patients with resistance to trastuzumab
  • Prior taxane therapy
  • Patients with an ECOG performance status of 0 - 2
  • Patients with measurable disease as per RECIST criteria
  • Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
  • Patients must meet laboratory criteria defined in the study within 21 days prior to randomization

Who cannot join

  • Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer
  • More than three prior chemotherapy lines for advanced disease.
  • Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed >8 weeks prior to randomization
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
  • Peripheral neuropathy ≥ grade 2 at randomization
  • Active cardiac disease
Show all 10Show fewer
  • History of cardiac dysfunction
  • Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
  • Known hypersensitivity to any study medication
  • Breastfeeding or pregnant

Trial locations and contacts

161 sites in 21 countries.

161 sites in 21 countries

United States43 sites

  • Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

    Atlanta, Georgia, 30322

  • Comprehensive Cancer Center - Boca Raton Deerfield Beach

    Boca Raton, Florida, 33248

  • Comprehensive Cancer Center - Boca Raton Dept.of BocaRatonCompCanCtr

    Boca Raton, Florida, 33248

  • Texas Cancer Center ( Medical City Dallas Hospital) Dept. of Texas Cancer Ctr. (2)

    Dallas, Texas, 75230

  • Texas Oncology Presbyterian Hospital (2)

    Dallas, Texas, 75246

  • Texas Oncology Texas Onc - Amarillo

    Dallas, Texas, 75246

  • Texas Oncology Texas Oncology - Sammons

    Dallas, Texas, 75246

  • Texas Oncology Midtown

    Dallas, Texas, 75251

  • University of Texas Southwestern Medical Center University of TX SW Med Ctr(2)

    Dallas, Texas, 75390-8852

  • Duke University Medical Center Dept. of DUMC (2)

    Durham, North Carolina, 27710

  • North Shore University Health System NSU

    Evanston, Illinois, 60201

  • Virginia Cancer Specialists Fairfax No.VA (2)

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists DeptofFloridaCancerSpecialists

    Fort Myers, Florida, 33916

  • The Jones Clinic Dept .of The Jones Clinic (3)

    Germantown, Tennessee, 38138

  • Green Bay Oncology Green Bay Oncology

    Green Bay, Wisconsin, 54301

  • Rocky Mountain Cancer Centers RMCC

    Greenwood Village, Colorado

  • Memorial Hospital Memorial Cancer Institute

    Hollywood, Florida, 33021

  • University of Texas/MD Anderson Cancer Center SC-5

    Houston, Texas, 77030-4009

  • Baylor College of Medicine Baylor

    Houston, Texas, 77030

  • University of California San Diego - Moores Cancer Center La Jolla - UCSD Moores Cancer

    La Jolla, California, 92093-0658

  • Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

    Lake Success, New York, 11042

  • Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

    Las Vegas, Nevada, 89109

  • Nevada Cancer Institute Dept. of Nevada Cancer (3)

    Las Vegas, Nevada, 89135

  • Longview Cancer Center Longview Cancer Center (2)

    Longview, Texas, 75601

  • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(6)

    Nashville, Tennessee, 37203

  • Virginia Oncology Associates Dept. of VOA (2)

    Norfolk, Virginia, 23502

  • University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

    Omaha, Nebraska, 68198

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

    Orlando, Florida, 32806

  • Kansas City Cancer Center KCCC- South (2)

    Overland Park, Kansas, 66210

  • Maryland Oncology Hematology

    Owning Mills, Maryland, 21117,

  • University of Pittsburgh Cancer Institute DeptofMageeWomen'sHospital(2)

    Pittsburgh, Pennsylvania, 15232

  • Northwest Cancer Specialists Tutlatin

    Portland, Oregon, 97210

  • Park Nicollet Institute Dept. of Park Nicollet

    Saint Louis Park, Minnesota, 55416

  • Utah Cancer Specialists Utah Cancer (2)

    Salt Lake City, Utah, 84106

  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

    San Antonio, Texas, 78229

  • South Texas Oncology and Hematology, PA South Texas Oncology (2)

    San Antonio, Texas, 78258

  • Swedish Cancer Institute Swedish Cancer Institute

    Seattle, Washington, 98104

  • St. Louis University Cancer Center SLU Cancer Center

    St Louis, Missouri, 63110

  • Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

    Summit, New Jersey, 07901

  • University of Arizona / Cancer Center AZ Onc Assoc

    Tucson, Arizona, 85724

  • University of Arizona / Cancer Center Deptof Uof A/Arizona Cancer(3)

    Tucson, Arizona, 85724

  • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

    Tyler, Texas, 75702

  • Georgetown University/Lombardi Cancer Center Dept.of Lombardi CancerCtr (3)

    Washington D.C., District of Columbia, 20007-2197

Other trials in United States

Spain15 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    A Coruña, Galicia, 15009

  • Novartis Investigative Site

    Barcelona, Barcelona, 08041

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28034

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Germany13 sites

  • Novartis Investigative Site

    Berlin, 14195

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Gerlingen, 70839

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20249

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Magdeburg, 39108

  • Novartis Investigative Site

    Mainz, Germany, 55131

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    München, 80638

  • Novartis Investigative Site

    Recklinghausen, 45657

  • Novartis Investigative Site

    Velbert, 42551

Other trials in Germany

Japan13 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1395

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577

  • Novartis Investigative Site

    Koto, Tokyo, 135-8550

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kyoto, Kyoto, 606-8507

  • Novartis Investigative Site

    Maebashi, Gunma, 371-8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464-8681

  • Novartis Investigative Site

    Osaka, Osaka, 537-8511

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Sapporo, Hokkaido, 003-0804

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Argentina9 sites

  • Novartis Investigative Site

    C A B A, Buenos Aires, C1019ABS

  • Novartis Investigative Site

    Caba, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5002AOQ

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Posadas, Misiones Province

  • Novartis Investigative Site

    Quilmes, Buenos Aires, B1878DVB

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

  • Novartis Investigative Site

    Rosario, Sante Fe, S200KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

France8 sites

  • Novartis Investigative Site

    Bayonne, 64100

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Hyères, 83400

  • Novartis Investigative Site

    La Chaussée-Saint-Victor, 41260

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Saint-Brieuc Cédex, 22015

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

United Kingdom7 sites

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Plymouth, PL6 8DH

  • Novartis Investigative Site

    Surrey, England, GU2 7XX

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Australia6 sites

  • Novartis Investigative Site

    East Bentleigh, Victoria, 3165

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Southport, Queensland, 4215

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065

Other trials in Australia

China6 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100039

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200032

  • Novartis Investigative Site

    Shanghai, 200025

Other trials in China

Greece6 sites

  • Novartis Investigative Site

    Athens, Greece, 18547

  • Novartis Investigative Site

    Athens, GR, 151 23

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Patra - RIO, GR, 265 04

  • Novartis Investigative Site

    Thessaloniki, GR, 546 45

  • Novartis Investigative Site

    Thessaloniki, GR, 564 03

Other trials in Greece

Italy6 sites

  • Novartis Investigative Site

    Catania, CT, 95125

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Sondrio, SO, 23100

Other trials in Italy

Belgium5 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Sint-Niklaas, 9100

Other trials in Belgium

Hungary4 sites

  • Novartis Investigative Site

    Budapest, 1062

  • Novartis Investigative Site

    Budapest, H-1122

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Győr, Hungary, H-9023

Other trials in Hungary

Israel4 sites

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Czechia3 sites

  • Novartis Investigative Site

    Nový Jičín, 741 01

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, 150 00

Other trials in Czechia

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Fatih / Istanbul, 34098

  • Novartis Investigative Site

    Izmir, Turkey, 35040

Other trials in Turkey (Türkiye)

Mexico2 sites

  • Novartis Investigative Site

    León, Guanajuato, 37000

  • Novartis Investigative Site

    Mexico City, Mexico City, 04980

Other trials in Mexico

Poland2 sites

  • Novartis Investigative Site

    Lublin, 20-090

  • Novartis Investigative Site

    Warsaw, 02-781

Other trials in Poland

Slovakia2 sites

  • Novartis Investigative Site

    Bratislava, 83310

  • Novartis Investigative Site

    Košice, 040 91

Other trials in Slovakia

Singapore1 site

  • Novartis Investigative Site

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

Official title: A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer.

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Being tested
everolimus, Placebo, vinorelbine, trastuzumab
Keywords
Metastatic breast cancer, locally advanced breast cancer, HER2/neu positive breast cancer, HER2/neu over-expressing, progressive-free survival (PFS), over survival (OS), bolero, bolero 3, Breast cancer, everolimus, HER+, vinorelbine, herceptin, trastuzumab, RAD001
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • everolimusDrug

    Also called RAD001

    Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

  • PlaceboDrug

    Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

  • vinorelbineDrug

    intravenous vinorelbine (25 mg/m2 weekly)

  • trastuzumabDrug

    intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Study groups in NCT01007942
Study groupRoleWhat they receive
Everolimus + vinorelbine + trastuzumabExperimentalOral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
Receives: Drug: everolimus; Drug: vinorelbine; Drug: trastuzumab
placebo + vinorelbine + trastuzumabPlacebo comparatorOral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only
Receives: Drug: Placebo; Drug: vinorelbine; Drug: trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progressive-free Survival (PFS) Per Investigator Assessment

    PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.

    Measured: Every 3 months until death up to 41 months

  2. Overall Response Rate (ORR)

    ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

  3. Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

    Measured: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

  4. Median Time to Deterioration of the ECOG Performance Status Score

    Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead

    Measured: baseline, until disease progression or death up to about 41 months

  5. PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)

    PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning [EF, PF, \& SF]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.

    Measured: Baseline, until disease progression or death up to about 41 months

  6. Everolimus Blood Concentrations by Leading Dose and Time Point

    Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.

    Measured: Cycle 2, Day 1

  7. Vinorelbine Blood Concentrations by Leading Dose and Time Point

    Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.

    Measured: Cycle 2, Day 1

  8. Trastuzumab Blood Concentrations by Leading Dose and Time Point

    Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.

    Measured: Cycle 3, Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007942
Sponsor's protocol ID
CRAD001W2301
Other IDs
2008-008697-31, 2008
Acronym
BOLERO-3
Status last verified
Feb 2017
First submitted
2 Nov 2009
Last updated
5 Apr 2017
Data monitoring committee
Yes

Publications

  • Andre F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, Masuda N, Wilks S, Arena F, Isaacs C, Yap YS, Papai Z, Lang I, Armstrong A, Lerzo G, White M, Shen K, Litton J, Chen D, Zhang Y, Ali S, Taran T, Gianni L. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 May;15(6):580-91. doi: 10.1016/S1470-2045(14)70138-X. Epub 2014 Apr 14.

    PubMed 24742739

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing everolimus, vinorelbine and trastuzumab in people with HER2/Neu Over-expressing Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 161 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Spain, Germany, Japan, Argentina and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progressive-free Survival (PFS) Per Investigator Assessment (time frame: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01007942, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.

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