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Breast CancerPhase 3BOLERO-1NCT00876395

Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing Everolimus, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Novartis Pharmaceuticals at 140 sites in 28 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

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Everolimus, Trastuzumab and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
719 participants
Where
140 sitesin 28 countries
Study dates
10 Sep 2009to 23 Oct 2017
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

  • Adult Women (≥ 18 years old).
  • Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
  • Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
  • HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
  • Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
  • Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
  • Documentation of negative pregnancy test.
  • Organ functions at time of inclusion.

Who cannot join

  • Prior mTOR inhibitors for the treatment of cancer.
  • Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
  • Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
  • Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
  • History of central nervous system metastasis.
  • Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
Show all 11Show fewer
  • Serious peripheral neuropathy.
  • Cardiac disease or dysfunction.
  • Uncontrolled hypertension.
  • HIV.
  • Pregnant,

Trial locations and contacts

140 sites in 28 countries.

140 sites in 28 countries

United States25 sites

  • New York Oncology Hematology NYOH Amsterdam

    Albany, New York, 12208

  • Comprehensive Blood and Cancer Center Dept. of CBCC (2)

    Bakersfield, California, 93309

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Texas Oncology Charles A. Sammons Cancer Ctr

    Dallas, Texas, 75246

  • Texas Oncology P A SC-Austin

    Dallas, Texas, 75251

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

    Fort Myers, Florida, 33901

  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center

    Fullerton, California, 92835

  • Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)

    Greenwood Village, Colorado

  • Central Indiana Cancer Centers CICC - East (3)

    Indianapolis, Indiana, 46227

  • University of California at Los Angeles Dept. of UCLA

    Los Angeles, California, 90095

  • University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

    Mobile, Alabama, 36688

  • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

    Nashville, Tennessee, 37203

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

    New York, New York, 10003

  • Virginia Oncology Associates SC

    Norfolk, Virginia, 23502

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

    Omaha, Nebraska, 68198

  • Kansas City Cancer Center Dept. of KCCC

    Overland Park, Kansas, 66210

  • Ventura County Hematology and Oncology

    Oxnard, California, 93030

  • Northwest Cancer Specialists Vancouver Cancer Center (3)

    Portland, Oregon, 97210

  • Cancer Care Associates Medical Group Dept. of CCA

    Redondo Beach, California, 90277

  • Virginia Cancer Institute VCI (3)

    Richmond, Virginia, 23230

  • Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation Onc Dept

    Santa Maria, California, 93454

  • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

Other trials in United States

Japan15 sites

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8677

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 104-8560

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1395

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193

  • Novartis Investigative Site

    Kashiwa, Chiba, 277-8577

  • Novartis Investigative Site

    Kitaadachi-gun, Saitama, 362-0806

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 802-0077

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464-8681

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Osaka, 537-8511

  • Novartis Investigative Site

    Sakyo-ku, Kyoto, 606 8507

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

Other trials in Japan

China10 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100039

  • Novartis Investigative Site

    Guangzhou, Guangdong, 51000

  • Novartis Investigative Site

    Guangzhou, 510060

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210002

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200032

  • Novartis Investigative Site

    Shanghai, 200025

Other trials in China

Argentina7 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Capital Federal, 1417

  • Novartis Investigative Site

    Córdoba, X5004BAL

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, B7600CTO

  • Novartis Investigative Site

    Posadas, Misiones Province

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

  • Novartis Investigative Site

    Rosario, Sante Fe, S200KZE

Other trials in Argentina

France7 sites

  • Novartis Investigative Site

    Limoges, 87000

  • Novartis Investigative Site

    Rouen, 76000

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Strasbourg, F 67098

  • Novartis Investigative Site

    Thonon-les-Bains, 74203

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Russia6 sites

  • Novartis Investigative Site

    Kazan', Tatarstan Republic, 420029

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 129128

  • Novartis Investigative Site

    Moscow, 143423

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Saint Petersburg, 198255

Other trials in Russia

Belgium5 sites

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Verviers, 4800

  • Novartis Investigative Site

    Wilrijk, 2610

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

Brazil5 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30380-490

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-001

Other trials in Brazil

Germany5 sites

  • Novartis Investigative Site

    Berlin, 10098

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Münster, 48149

Other trials in Germany

Greece5 sites

  • Novartis Investigative Site

    Athens, GR, 151 23

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Athens, 18547

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Thessaloniki, GR, 564 03

Other trials in Greece

Italy5 sites

  • Novartis Investigative Site

    Camposampiero, PD, 35012

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Roma, RM, 00128

Other trials in Italy

Taiwan5 sites

  • Novartis Investigative Site

    Kaohsiung City, 80756

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taipei, Taiwan, ROC, 11217

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Colombia4 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 0000

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Florida Blanca

  • Novartis Investigative Site

    Montería

Other trials in Colombia

South Korea4 sites

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, Korea, 06351

  • Novartis Investigative Site

    Seoul, 02841

  • Novartis Investigative Site

    Seoul, 03722

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Altunizade, 34662

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Canada3 sites

  • Novartis Investigative Site

    Montreal, Quebec, H2W 1S6

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5

  • Novartis Investigative Site

    Saint-Jérôme, Quebec, J7Z 5T3

Other trials in Canada

Hong Kong3 sites

  • Novartis Investigative Site

    Hong Kong SAR

  • Novartis Investigative Site

    Shatin, New Territories, Hong Kong

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

South Africa3 sites

  • Novartis Investigative Site

    Bloemfontein, 9301

  • Novartis Investigative Site

    Durban, 4091

  • Novartis Investigative Site

    Pretoria, 0002

Other trials in South Africa

United Kingdom3 sites

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Sutton, SM2 5PT

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Australia2 sites

  • Novartis Investigative Site

    East Bentleigh, Victoria, 3165

  • Novartis Investigative Site

    Southport, Queensland, 4215

Other trials in Australia

Egypt2 sites

  • Novartis Investigative Site

    Alexandria

  • Novartis Investigative Site

    Cairo

Other trials in Egypt

Ireland2 sites

  • Novartis Investigative Site

    Dublin

  • Novartis Investigative Site

    Wilton, Cork

Other trials in Ireland

Lebanon2 sites

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    El Achrafiyé, 166830

Other trials in Lebanon

Mexico2 sites

  • Novartis Investigative Site

    Mexico City, Mexico City, 04980

  • Novartis Investigative Site

    Zaragoza, Veracruz, 91910

Other trials in Mexico

Peru2 sites

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    Surquillo, Lima region, 34

Other trials in Peru

Switzerland2 sites

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Zurich, 8038

Other trials in Switzerland

Puerto Rico1 site

  • San Juan VA Hospital San Juan Hospital

    San Juan, 00921

Other trials in Puerto Rico

Venezuela1 site

  • Novartis Investigative Site

    Valencia, Carabobo, 2001

Other trials in Venezuela

About this study

Official title: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

Conditions
Breast Cancer
Being tested
Everolimus, Placebo, Trastuzumab, Paclitaxel
Keywords
Breast Cancer, HER2+, mTOR, everolimus, RAD001, first line, metastatic, locally advanced, Trastuzumab, Paclitaxel, First Line Therapy, HER2 Positive, Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • EverolimusDrug

    Also called RAD001

    Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

  • PlaceboDrug

    Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

  • TrastuzumabDrug

    Trastuzumab, 2 mg/kg weekly was used intravenously.

  • PaclitaxelDrug

    Paclitaxel, 80 mg/m2 weekly was used intravenously.

Study groups in NCT00876395
Study groupRoleWhat they receive
Everolimus + Paclitaxel + TrastuzumabExperimentalEverolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
Receives: Drug: Everolimus; Drug: Trastuzumab; Drug: Paclitaxel
Placebo + Paclitaxel + TrastuzumabPlacebo comparatorPlacebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22
Receives: Drug: Placebo; Drug: Trastuzumab; Drug: Paclitaxel

What is being measured

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

  1. Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population

    PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.

    Measured: 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 56 months

  2. Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - (Hormone Receptor (HR)-Negative Population

    PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the HR-negative patient population.

    Measured: 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 56 months

Secondary outcomes (15)

  1. Overall Survival (OS) - Full Population

    OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the full patient population.

    Measured: up to about 76 months

  2. Overall Survival (OS) - HR-negative Population

    OS is defined as the time from date of randomization to the date of death due to any cause. For patients with documented progression, survival follow up was performed either by telephone or clinic visit at least every 3 months. Additional survival updates were requested prior to interim or final analysis or prior to providing data to the health authorities. This was assessed in the HR-negative patient population.

    Measured: up to about 76 months

  3. Overall Response Rate (ORR) - Full Population

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  4. Overall Response Rate (ORR) - HR-negative Population

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  5. Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - Full Population

    CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  6. Clinical Benefit Rate (CBR) Equal to or Greater Than 24 Weeks - HR-negative Population

    CBR is defined as the percentage of participants whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST. This was assessed in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  7. Time to Overall Response Based on Investigator - Full Population

    Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  8. Time to Overall Response Based on Investigator - HR-negative Population

    Time to overall response defined as the time between date of randomization until first documented response Complete reseponse (CR) or partial response (PR) ), according to RECIST. This was assessed in the full patient population and in a subset of patients with Hormone Receptor Negative disease. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  9. Overall Response (OR) - Full Population

    OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  10. Overall Response (OR) - HR-negative Population

    OR applies only to patients whose best OR was CR or PR. Start date = date of first documented response (CR or PR) and end date = date of documented response (CR or PR) and end date = date of event defined as the first documented progression or death due to underlying cause. This was assessed in the HR-negative patient population. Complete response is achieved when all lesions evaluated at Baseline are absent at subsequent visit.

    Measured: up to about 23 months

  11. Everolimus Blood Level Concentrations at Steady States for Everolimus

    Blood levels at steady states for everolimus 10 mg/day and 5 mg/day. Only valid samples are included. Some patients had dose reduction to 5 mg daily dose therefore the everolimus blood concentration for them have been summarized separately. Cycle = 28 days

    Measured: predose, 2 hours post-dose at Cycle 2/Day 1, Cycle 2/Day 15, Cycle 2/ Day 22

  12. Paclitaxel Plasma Concentrations

    Blood levels at steady states for everolimus/placebo

    Measured: Cycle 2/Day 15 (Pre-infusion and end of infusion)

  13. Trastuzumab Serum Concentrations

    Blood levels at steady states for everolimus/placebo

    Measured: Cycle 4/Day 1 (Pre-infusion and end of infusion)

  14. Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - Full Population

    Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.

    Measured: up to about 56 months

  15. Time to Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score - HR-negative Population

    Time to definitive deterioration of the ECOG PS by one category of the score from baseline will be performed. Baseline is the last available assessment on or before randomization date. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at a subsequent time of measurement during the treatment period following the time point where the deterioration is observed.

    Measured: up to about 56 months

Timeline

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

  1. First posted6 Apr 2009 (estimated)
  2. Study start10 Sep 2009
  3. Primary completion30 May 2014
  4. Study completion23 Oct 2017

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00876395
Sponsor's protocol ID
CRAD001J2301
Other IDs
2008-006556-21, 2008
Acronym
BOLERO-1
Status last verified
Dec 2018
First submitted
2 Apr 2009
Last updated
19 Dec 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0.

    PubMed 28399902

  • Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing .... Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9.

    PubMed 26861602

  • Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16.

    PubMed 26092818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus, Trastuzumab and Paclitaxel in people with Breast Cancer, run by Novartis Pharmaceuticals at 140 sites in 28 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 11 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Japan, China, Argentina, France and 23 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 19 Dec 2018). 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?

Progression-free Survival (PFS) Per Investigators' Assessment Based on Local Radiology Review - Full Population (time frame: 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 56 months). The study lists 2 primary outcomes in all. 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 NCT00876395, which also lists 3 linked publications.

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 19 Dec 2018.

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