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Breast CancerPhase 2NCT01740336

A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer

A Phase 2 study testing GDC-0941 and Paclitaxel in people with Breast Cancer, run by Genentech, Inc. at 97 sites in 8 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 multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or 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?
GDC-0941 and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
97 sitesin 8 countries
Study dates
6 Feb 2013to 10 Dec 2015
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

  • Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
  • Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function
  • Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer

Who cannot join

  • Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
  • Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor for advanced or metastatic breast cancer
  • History of intolerance to a taxane-containing therapy
  • History of clinically significant cardiac or pulmonary dysfunction
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • Clinically significant history of liver disease
Show all 12Show fewer
  • Active autoimmune disease or active inflammatory disease
  • Immunocompromised status due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions
  • Need for current chronic corticosteroid therapy
  • Pregnant, lactating, or breastfeeding women
  • Current severe, uncontrolled systemic disease
  • Known untreated or active central nervous system (CNS) metastases

Trial locations and contacts

97 sites in 8 countries.

97 sites in 8 countries

United States47 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Pacific Cancer Medical Center

    Anaheim, California, 92801

  • Maine Research Associates

    Auburn, Maine, 04210

  • Shivers Cancer Center at University Medical Center Brackenridge

    Austin, Texas, 78701

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Texas Oncology

    Bedford, Texas, 76022

  • Billings Clinic Cancer Center-CCD PRIME

    Billings, Missouri, Montana

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Med Ctr

    Brookline, Massachusetts, 02445

  • Aultman Hospital; Aultman Hospital Cancer Center

    Canton, Ohio, 44710

  • TriHealth Oncology Institute

    Cincinnati, Ohio, 45247

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • Texas Oncology, P.A. - El Paso; West

    El Paso, Texas, 79902

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92008

  • Hematology and Oncology Associates of Sc

    Greenville, South Carolina, 29615

  • Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research

    Hartford, Connecticut, 06102-5037

  • Kaiser Permanente - Hayward

    Hayward, California, 94545

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Joliet Oncology-Hematology; Associates, Ltd.

    Joliet, Illinois, 60435

  • ProHEALTH Care Associates LLP

    Lake Success, New York, 11042

  • Metairie Oncologist, LLC

    Metairie, Louisiana, 70006

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Northern Utah Associates

    Ogden, Utah, 84403

  • Nebraska Cancer Specialists; Oncology Hematology West, PC

    Omaha, Nebraska, 68130

  • Cancer Specialists of North Florida

    Orange Park, Florida, 32073

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Bay Area Cancer Research Group, LLC

    Pleasant Hill, California, 94523

  • Hematology - Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Kaiser Permanente - San Francisco (2238 Geary)

    San Francisco, California, 94115

  • University of California at San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente - San Jose

    San Jose, California, 95119

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • Swedish Health Services

    Seattle, Washington, 98122

  • Arizona Oncology Associates, PC - NAHOA

    Sedona, Arizona, 86336

  • Texas Oncology, P.A. ;Sherman Cancer Center

    Sherman, Texas, 75090-0504

  • Kaiser Permanente - South San Francisco

    South San Francisco, California, 94080

  • Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596

  • Shenandoah Oncology Associates

    Winchester, Virginia, 22601

Other trials in United States

Australia13 sites

  • Bendigo Hospital; Oncology

    Bendigo, Victoria, 3550

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Peninsula and South Eastern Haematology and Oncology Grou

    Frankston, Victoria, 3199

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Mater Adult Hospital

    Mackay, Queensland, 4740

  • Royal Perth Hospital; Medical Oncology

    Perth, Western Australia, 6000

  • Port Macquarie Base Hospital;North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444

  • Sydney Haematology & Oncology Clinic

    Wahroonga, New South Wales, 2076

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

  • Border Medical Oncology

    Wodonga, New South Wales, 3690

Other trials in Australia

United Kingdom10 sites

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts Hospital

    London, E1 2EF

  • The Christie

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia7 sites

  • Fakultni nemocnice Brno

    Brno, 613 00

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63

  • Multiscan s.r.o.

    Pardubice, 532 03

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Nemocnice Na Bulovce

    Prague, 180 01

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Antwerpen

    Edegem, 2650

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU Ambroise Paré

    Mons, 7000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Spain5 sites

  • Institut Catala d´Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital General Univ. Gregorio Maranon

    Madrid, 28009

  • START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

    Madrid, 28050

Other trials in Spain

Austria4 sites

  • Lkh-Univ. Klinikum Graz

    Graz, 8036

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel

    Vienna, 1130

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

About this study

Official title: A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.

Conditions
Breast Cancer
Being tested
GDC-0941, Placebo, 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.

  • GDC-0941Drug

    GDC-0941 will be administered QD orally for 5 consecutive days each week.

  • PlaceboDrug

    Placebo matching to GDC-0941

  • PaclitaxelDrug

    Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.

Study groups in NCT01740336
Study groupRoleWhat they receive
A: Paclitaxel, GDC-0941ExperimentalParticipants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.
Receives: Drug: GDC-0941; Drug: Paclitaxel
B: Paclitaxel, PlaceboPlacebo comparatorParticipants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.
Receives: Drug: Placebo; Drug: Paclitaxel

What is being measured

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

  1. Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

    Measured: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)

Secondary outcomes (6)

  1. Percentage of Participants With Adverse Events

    Measured: From randomization up to approximately 3 years

  2. Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1

    Measured: From first observation of an objective tumor response until disease progression (up to approximately 3 years)

  3. Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1

    Measured: From randomization until disease progression (up to approximately 3 years)

  4. Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1

    Measured: From first observation of an objective tumor response until disease progression (up to approximately 3 years)

  5. Population Pharmacokinetics (PK) for GDC-0941

    Measured: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)

  6. Population PK for Paclitaxel

    Measured: Day 1 of Cycle 1 (cycle length=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 posted4 Dec 2012 (estimated)
  2. Study start6 Feb 2013
  3. Primary completion20 Oct 2015
  4. Study completion10 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740336
Sponsor's protocol ID
GO28509
Other IDs
2012-003262-41
Status last verified
Apr 2017
First submitted
30 Nov 2012
Last updated
24 Apr 2017
Results posted
No

Publications

  • Vuylsteke P, Huizing M, Petrakova K, Roylance R, Laing R, Chan S, Abell F, Gendreau S, Rooney I, Apt D, Zhou J, Singel S, Fehrenbacher L. Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study. Ann Oncol. 2016 Nov;27(11):2059-2066. doi: 10.1093/annonc/mdw320. Epub 2016 Aug 29.

    PubMed 27573562

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GDC-0941 and Paclitaxel in people with Breast Cancer, run by Genentech, Inc. at 97 sites in 8 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 5 inclusion and 12 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 24 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 97 sites in United States, Australia, United Kingdom, Czechia, Belgium and 3 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?

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) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) (time frame: From the time of randomization until disease progression or death from any cause (up to approximately 3 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 NCT01740336, 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 24 Apr 2017.

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