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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01740336




Registration number
NCT01740336
Ethics application status
Date submitted
30/11/2012
Date registered
4/12/2012
Date last updated
24/04/2017

Titles & IDs
Public title
A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
Scientific title
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
Secondary ID [1] 0 0
2012-003262-41
Secondary ID [2] 0 0
GO28509
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GDC-0941
Treatment: Drugs - Placebo
Treatment: Drugs - Paclitaxel

Experimental: A: Paclitaxel, GDC-0941 - Participants 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.

Placebo Comparator: B: Paclitaxel, Placebo - Participants 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.


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

Treatment: Drugs: Placebo
Placebo matching to GDC-0941

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Timepoint [1] 0 0
From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
From randomization up to approximately 3 years
Secondary outcome [2] 0 0
Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1
Timepoint [2] 0 0
From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From randomization until disease progression (up to approximately 3 years)
Secondary outcome [4] 0 0
Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1
Timepoint [4] 0 0
From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Secondary outcome [5] 0 0
Population Pharmacokinetics (PK) for GDC-0941
Timepoint [5] 0 0
Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Secondary outcome [6] 0 0
Population PK for Paclitaxel
Timepoint [6] 0 0
Day 1 of Cycle 1 (cycle length=28 days)

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/12/2015
Sample size
Target
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Port Macquarie Base Hospital;North Coast Cancer Institute - Port Macquarie
Recruitment hospital [4] 0 0
Sydney Haematology & Oncology Clinic - Wahroonga
Recruitment hospital [5] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [6] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Mater Adult Hospital - Mackay
Recruitment hospital [9] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Bendigo Hospital; Oncology - Bendigo
Recruitment hospital [12] 0 0
Peninsula and South Eastern Haematology and Oncology Grou - Frankston
Recruitment hospital [13] 0 0
Royal Perth Hospital; Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2076 - Wahroonga
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
3690 - Wodonga
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4740 - Mackay
Recruitment postcode(s) [9] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3550 - Bendigo
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Maine
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Massachusetts
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Michigan
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Nebraska
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Ohio
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Utah
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Virginia
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Washington
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Austria
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Graz
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Austria
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Salzburg
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Austria
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Wels
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Wien
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Brussels
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Edegem
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Leuven
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Mons
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Namur
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Wilrijk
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Brno
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Liberec
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Pardubice
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Prague
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Barcelona
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Jaen
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Madrid
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Brighton
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Guildford
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Leicester
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Manchester
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Newcastle upon Tyne
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Nottingham
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Stoke on Trent
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Truro
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01740336
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01740336