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Breast CancerPhase 2NCT01186991

Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer

A Phase 2 study testing Onartuzumab, Bevacizumab and Paclitaxel in people with Breast Cancer, run by Genentech, Inc. at 53 sites in 6 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 is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in… 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?
Onartuzumab, Bevacizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
185 participants
Where
53 sitesin 6 countries
Study dates
Mar 2011to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)-, and human epidermal growth factor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast
  • Confirmed availability of tumor tissue

Who cannot join

  • Prior therapy with two or more regimens for metastatic breast cancer
  • Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
  • Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1
  • Prior therapy with a taxane for metastatic breast cancer
  • Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative vascular endothelial growth factor (VEGF) pathway-targeted therapy following diagnosis of breast cancer
  • Prior therapy with hormones and/or trastuzumab
Show all 10Show fewer
  • Inadequate hematology, renal, or hepatic organ function
  • Bevacizumab Exclusion Criteria:
  • Uncontrolled hypertension (systolic pressure greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic pressure > 100 mmHg), with or without anti-hypertensive medication
  • Evidence of bleeding diathesis or coagulopathy

Trial locations and contacts

53 sites in 6 countries.

53 sites in 6 countries

United States23 sites

  • Comprehensive Blood/Cancer Ctr

    Bakersfield, California, 93309

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29414

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • South Carolina Onc. Associate

    Columbia, South Carolina, 29210

  • Karmanos Cancer Institute..

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Shore Hem Onc Associates

    East Setauket, New York, 11733

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists; SCRI

    Fort Myers, Florida, 33916

  • St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

    Fullerton, California, 92835

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Suburban Hematology Oncology

    Lawrenceville, Georgia, 30045

  • Can Care Assoc Med Group Inc; Beach Cities Offices

    Los Angeles, California, 90095-1772

  • Univ of California Los Angeles

    Los Angeles, California, 90095

  • The Sarah Cannon Research Inst

    Nashville, Tennessee, 37203

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Sharp Healthcare; Oncology Research Program

    San Diego, California, 92123

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

Other trials in United States

France9 sites

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Francois Baclesse; Gastro-Enterologie

    Caen, 14076

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Centre Leon Berard

    Lyon, 69008

  • Institut régional du Cancer Montpellier

    Montpellier, 34298

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Centre Rene Huguenin; CONSULT SPECIALISEES

    Saint-Cloud, 92210

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

Other trials in France

Belgium7 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Antwerpen

    Edegem, 2650

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • CH Jolimont - Lobbes (Jolimont)

    Haine-Saint-Paul, 7100

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • CHU Sart-Tilman

    Liège, 4000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Spain5 sites

  • Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

    A Coruña, La Coruña, 15009

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, Barcelona, 08035

  • Instituto Catalán de Oncología; Servicio de Farmacia

    Barcelona, Barcelona, 08907

  • Hospital Universitario Puerta del Mar; Servicio de Oncologia

    Cadiz, Cadiz, 11009

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

United Kingdom5 sites

  • Brighton and Sussex Univ Hosp

    Brighton, BN2 5BD

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • The Clatterbridge Cancer Ctr For Oncolgy

    Metropolitan Borough of Wirral, CH63 4JY

  • Mount Vernon Hospital; Centre For Cancer Treatment

    Northwood, HA6 2RN

  • Nottingham City Hospital; Oncology

    Nottingham, NG5 1PB

Other trials in United Kingdom

Germany4 sites

  • Praxis Dr. med. Klausmann; SHOD

    Aschaffenburg, 63739

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt am Main, 60590

  • Klinikum rechts der Isar der TU München; Frauenklinik

    München, 81675

  • Universitätsklinik Tübingen; Frauenklinik

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer

This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).

Conditions
Breast Cancer
Being tested
Onartuzumab, Bevacizumab, Paclitaxel, Bevacizumab Placebo, Onartuzumab Placebo
Medical subject headings
Breast Neoplasms

What participants receive

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

  • OnartuzumabDrug

    Also called MetMAb

    Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.

  • Bevacizumab PlaceboDrug

    Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.

  • Onartuzumab PlaceboDrug

    Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.

Study groups in NCT01186991
Study groupRoleWhat they receive
Onartuzumab + Bevacizumab + PaclitaxelExperimentalParticipants will receive treatment with onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable drug-related toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Receives: Drug: Onartuzumab; Drug: Bevacizumab; Drug: Paclitaxel
Onartuzumab + Placebo + PaclitaxelExperimentalParticipants will receive treatment with onartuzumab, placebo matching to bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Receives: Drug: Onartuzumab; Drug: Paclitaxel; Drug: Bevacizumab Placebo
Placebo + Bevacizumab + PaclitaxelActive comparatorParticipants will receive treatment with placebo matching to onartuzumab, bevacizumab, and paclitaxel, which may continue until disease progression, unacceptable toxicity, investigator decision, death, or completion of study, whichever occurs first (up to approximately 5 years).
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Onartuzumab Placebo

What is being measured

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

  1. Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants Who Have not Received Prior Systemic Therapy or Have Progressed to Prior First-line Treatment

    Measured: From randomization until disease progression (PD), relapse, or death on study (within 30 days of last study drug administration) from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

Secondary outcomes (8)

  1. PFS According to RECIST v1.1 in Participants Who Have not Received Prior Systemic Therapy

    Measured: From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

  2. Percentage of Participants With Objective Response as Assessed by the Investigator According to RECIST v1.1

    Measured: From randomization until PD, relapse, or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

  3. Duration of Response as Assessed by the Investigator Using RECIST v1.1

    Measured: From initial objective response to PD or death on study from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)

  4. Overall Survival (OS)

    Measured: From randomization until death from any cause, loss to follow-up, study termination by sponsor, or participant's withdrawal in survival follow-up (overall up to 5 years)

  5. Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)

    Measured: Day 1 Cycle 1 (cycle length=28 days) up to 30 days after last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)

  6. Number of Cycles of Treatment Received for Onartuzumab, Paclitaxel, and Bevacizumab During the Study

    Measured: Day 1 Cycle 1 (cycle length=28 days) up to last dose of study drug or study discontinuation/termination, whichever is later (overall up to 5 years)

  7. Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab

    Measured: Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)

  8. Serum Levels of ATAs Against Onartuzumab

    Measured: Predose on Day 1 of Cycles 1-4 (cycle length=28 days), 30 days after last administration of onartuzumab or initiation of another therapy (overall up to 5 years)

Timeline

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

  1. First posted23 Aug 2010 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2016
  4. Study completionMar 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01186991
Sponsor's protocol ID
OAM4861g
Other IDs
GO01334, 2010-020101-32
Status last verified
Jan 2017
First submitted
9 Aug 2010
Last updated
20 Jan 2017
Results posted
No

Publications

  • Dieras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.

    PubMed 26202594

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Onartuzumab, Bevacizumab and Paclitaxel in people with Breast Cancer, run by Genentech, Inc. at 53 sites in 6 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 3 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, France, Belgium, Spain, United Kingdom and 1 more country. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants Who Have not Received Prior Systemic Therapy or Have Progressed to Prior First-line Treatment (time frame: From randomization until disease progression (PD), relapse, or death on study (within 30 days of last study drug administration) from any cause, whichever occurs first (to be assessed according to local standard of care overall up to 5 years)). 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 NCT01186991, 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 20 Jan 2017.

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