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Breast CancerPhase 2NCT02322814

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

A Phase 2 study testing Cobimetinib, Paclitaxel and Atezolizumab in people with Breast Cancer, run by Hoffmann-La Roche at 53 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Cobimetinib, Paclitaxel and Atezolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
169 participants
Where
53 sitesin 13 countries
Study dates
12 Mar 2015to 17 Sep 2021
Phase
Phase 2
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
  • All sexes
  • 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)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor 2 (HER2)-negative adenocarcinoma of the breast with measurable metastatic or locally advanced disease
  • Locally advanced disease must not be amenable to resection with curative intent
  • Measurable disease, according to RECIST, v1.1
  • Adequate hematologic and end organ function
  • Agreement to use highly effective contraceptive methods as stated in protocol

Who cannot join

  • Disease-Specific Exclusion Criteria
  • Known HER2-, ER-positive, or PR-positive breast cancer by local laboratory assessment
  • Any prior chemotherapy, hormonal, or targeted therapy, for inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC)
  • Any systemic anticancer therapy within 3 weeks prior to Cycle 1, Day 1
  • Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
  • Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for major surgical procedure during the course of the study
Show all 34Show fewer
  • Prior exposure to experimental treatment targeting rapidly accelerated fibrosarcoma (Raf), MAP kinase/ERK kinase (MEK), or the mitogen-activated protein kinase (MAPK) pathway
  • Brain metastases (symptomatic or nonsymptomatic) that have not been treated previously, are progressive, or require any type of therapy (e.g., radiation, surgery, or steroids) to control symptoms from brain metastases within 30 days prior to first study treatment dose
  • Cobimetinib-Specific Exclusion Criteria
  • History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
  • Cobimetinib is metabolized by the hepatic cytochrome P3A4 (CYP3A4) enzyme. Drugs CYP3A4/5 inhibitors and inducers should be avoided
  • Atezolizumab-Specific Exclusion Criteria (Cohorts II and III Only)
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogenic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] or positive hepatitis B virus [HBV] deoxyribonucleic acid [DNA] test at screening) or hepatitis C
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
  • Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death ligand-1 (anti-PD-L1) therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or Interlukin-2 [IL-2]) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
  • Cardiac Exclusion Criteria
  • History of clinically significant cardiac dysfunction
  • Corrected QT interval at screening greater than (>) 480 milliseconds (ms) (average of triplicate screening measurements)
  • Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50 percent (%), whichever is lower
  • General Exclusion Criteria
  • No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay
  • Pregnancy (positive serum pregnancy test) or lactation
  • Uncontrolled serious medical or psychiatric illness
  • Active infection requiring IV antibiotics on Cycle 1, Day 1
  • Participants who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil) or to nab-paclitaxel and any of the excipients

Trial locations and contacts

53 sites in 13 countries.

53 sites in 13 countries

United States11 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256-6932

  • Mercy Hospital, a Campus of Plantation General Hospital

    Miami, Florida, 33133

  • Cancer Treatment Centers of America

    Newnan, Georgia, 30265

  • Florida Hospital Cancer Inst

    Orlando, Florida, 32804

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Florida Cancer Research Institute

    Plantation, Florida, 33324

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Montefiore Einstein Cancer Center

    The Bronx, New York, 10461

Other trials in United States

Spain7 sites

  • Hospital Universitario Infanta Cristina; Servicio de Oncologia

    Badajoz, 06080

  • Organización Sanitaria Integrada Bilbao Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Fundacion Jimenez Diaz; Servicio de Oncologia

    Madrid, 28040

  • Hospital Clinico San Carlos; Servicio de Nefrologia

    Madrid, 28040

  • Hosp. Regional Univ. de Malaga ? Hospital Materno Infantil; Hospital Materno Infantil de Malaga

    Málaga, 29011

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

Other trials in Spain

Italy6 sites

  • Centro Di Riferimento Oncologico; SOC Oncologia Medica C

    Aviano, Friuli Venezia Giulia, 33081

  • A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2

    Bologna, Emilia-Romagna, 40138

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliero Universitaria Seconda Università Degli Studi Di Napoli

    Naples, Campania, 80131

  • Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

    Pisa, Tuscany, 56126

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Belgium5 sites

  • Clinique Edith Cavell

    Brussels, 1180

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • AZ Sint Augustinus Veurne

    Veurne, 8630

Other trials in Belgium

Australia4 sites

  • Peter MacCallum Cancer Centre; Medical Oncology

    Melbourne, Victoria, 3000

  • St John of God Murdoch Hospital; Oncology West

    Murdoch, Western Australia, 6150

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

France4 sites

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

    Montpellier, 34298

  • Hopital Tenon

    Paris, 75020

  • Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

    Rennes, 35000

Other trials in France

South Korea4 sites

  • National Cancer Center; Medical Oncology

    Gyeonggi-do, 410-769

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

  • Yonsei University Health System/Severance Hospital

    Seoul, 120-752

Other trials in South Korea

United Kingdom3 sites

  • Nuffield Health Bournemouth Hospital

    Bournemouth, BH1 1RW

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB

Other trials in United Kingdom

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Multiscan s.r.o.

    Pardubice, 532 03

Other trials in Czechia

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Romania2 sites

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

Other trials in Romania

Taiwan2 sites

  • Chang Gung Memorial Hospital

    Kaohsiung Country, 833

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 11259

Other trials in Taiwan

Israel1 site

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

About this study

Official title: A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.

Conditions
Breast Cancer
Being tested
Cobimetinib, Paclitaxel, Placebo, Atezolizumab, Nab-Paclitaxel
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CobimetinibDrug

    Also called GDC-0973; RO5514041; XL518

    Cobimetinib will be administered orally at a dose of 60 milligrams (mg) per day, once a day, on Day 3 through Day 23 of each 28-day treatment cycle.

  • PaclitaxelDrug

    Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) by intravenous (IV) infusion on Day 1, Day 8, and Day 15 of each 28-day cycle according to prescribing information.

  • PlaceboDrug

    Placebo matching to cobimetinib will be administered orally, once a day, on Day 3 through Day 23 of each 28 day treatment cycle.

  • AtezolizumabDrug

    Also called MPDL3280A

    Atezolizumab will be administered to Cohorts II and III at a dose of 840 mg IV every 2 weeks on Days 1 and 15 of each 28-day treatment cycle.

  • Nab-PaclitaxelDrug

    Nab-Paclitaxel will be administered to Cohort III according to the local prescribing information at a starting dose of 100 mg/m^2 by IV infusion on Days 1, 8, and 15 of each 28 day cycle.

Study groups in NCT02322814
Study groupRoleWhat they receive
Cohort I: Cobimetinib, PaclitaxelExperimentalParticipants will receive a combination of cobimetinib plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Receives: Drug: Cobimetinib; Drug: Paclitaxel
Cohort I: Placebo, PaclitaxelPlacebo comparatorParticipants will receive a combination of cobimetinib placebo plus paclitaxel in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Receives: Drug: Paclitaxel; Drug: Placebo
Cohort II:Cobimetinib,Paclitaxel,AtezolizumabExperimentalParticipants will receive cobimetinib plus paclitaxel plus atezolizumab in 28-day cycles until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Receives: Drug: Cobimetinib; Drug: Paclitaxel; Drug: Atezolizumab
Cohort III: Cobimetinib, Nab-Paclitaxel, AtezolizumabExperimentalParticipants will receive cobimetinib plus nab-paclitaxel plus atezolizumab until disease progression, unacceptable toxicity, investigator decision, death, withdrawal of consent, or completion of study.
Receives: Drug: Cobimetinib; Drug: Atezolizumab; Drug: Nab-Paclitaxel

What is being measured

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

  1. Cohort I: Progression-Free Survival, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.

    Measured: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)

  2. Cohort II, III: Percentage of Participants With Confirmed Overall Response (OR) (Partial Response [PR] or Complete Response [CR]), as Determined by the Investigator Using RECIST v1.1

    OR was defined as the rate of a PR or CR occurring after randomization and confirmed >=28 days later as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

    Measured: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 5.25 years)

Secondary outcomes (18)

  1. Cohort I, II, III: Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause

    Measured: Randomization up to death from any cause (up to approximately 6.5 years)

  2. Cohort I: Percentage of Participants With Confirmed OR (PR or CR), as Determined by the Investigator Using RECIST v1.1

    OR was defined as the rate of a PR or CR occurring after randomization and confirmed >=28 days later as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

    Measured: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)

  3. Cohort I, II, III: Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1

    DOR was defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator using RECIST v1.1 or death from any cause during the study, whichever occurred first.

    Measured: Time from the first occurrence of documented objective response to time of relapse or death, whichever occurs first (up to approximately 6.5 years)

  4. Cohort I, II, III: Percentage of Participants With Unconfirmed Overall Response (OR_uc) (Unconfirmed PR or CR), as Determined by the Investigator Using RECIST v1.1

    ORR_uc (ORR confirmation not required) was defined as the rate of a PR or CR occurring after randomization as determined by the investigator using RECIST v1.1, confirmation not required. As per RECIST v1.1, CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target and new measurable lesions.

    Measured: Randomization up to disease progression or relapse, whichever occurs fist (up to approximately 6.5 years)

  5. Cohort II, III: Progression-Free Survival, as Determined by Investigator Using RECIST v1.1

    PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 6.5 years)

  6. Cohort I, II, III: Percentage of Participants With Adverse Events (AEs)

    Measured: Randomization up to end of study (up to approximately 6.5 years)

  7. Cohort I, II, III: Maximum Plasma Concentration (Cmax) of Cobimetinib

    Measured: Safety Run-In: Predose (Hour [Hr] 0) on Cycle (Cy) 1 Day (D) 8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)

  8. Cohort I, II, III: Minimum Plasma Concentration (Cmin) of Cobimetinib

    Measured: Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)

  9. Cohort I: Area Under the Concentration-Time Curve From Time Zero to Dosing Interval (AUC0-tau; Total Exposure) of Cobimetinib

    Measured: Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15 (Cy=28 days)

  10. Cohort I, II: Cmax of Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

  11. Cohort I, II: Cmin of Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

  12. Cohort I: AUC0-tau of Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)

  13. Cohort III: Cmax of Nab-Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

  14. Cohort III: Cmin of Nab-Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

  15. Cohort III: AUC0-tau of Nab-Paclitaxel

    Measured: Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)

  16. Cohort II, III: Cmax (in Serum) of Atezolizumab

    Measured: Safety Run-In, Expansion:Predose (Hr0), 0.5Hr postdose (infusion duration:1Hr) on D1 of Cy1, 3; predose (Hr0) on D1 of Cy2, 4, 8, every 8 Cy up to end of treatment (EOT); 120 days after EOT (approximately 5.25 years) (Cy=28 days)

  17. Cohort II, III: Cmin (in Serum) of Atezolizumab

    Measured: Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT; 120 days after EOT (approximately 5.5 years) (Cy=28 days)

  18. Cohort II, III: AUC0-tau (in Serum) of Atezolizumab

    Measured: Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT (approximately 5.5 years); 120 days after EOT (approximately 5.5 years) (Cy=28 days)

Timeline

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

  1. First posted23 Dec 2014 (estimated)
  2. Study start12 Mar 2015
  3. Primary completion10 Aug 2018
  4. Study completion17 Sep 2021

Why it stopped: Sponsor's decision

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
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02322814
Sponsor's protocol ID
WO29479
Other IDs
2014-002230-32, 2014
Status last verified
Mar 2023
First submitted
19 Dec 2014
Last updated
13 Apr 2023

Publications

  • Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

    PubMed 36310331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cobimetinib, Paclitaxel and Atezolizumab in people with Breast Cancer, run by Hoffmann-La Roche at 53 sites in 13 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 6 inclusion and 34 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: stopped early, as of the sponsor's last update on 13 Apr 2023. 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, Spain, Italy, Belgium, Australia and 8 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 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?

Yes. Results are posted in the registry (first posted 13 Nov 2019). 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?

Cohort I: Progression-Free Survival, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: Randomization up to disease progression or relapse, whichever occurs first (up to approximately 2 years)). 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 NCT02322814, 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 13 Apr 2023.

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