A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Front-line Treatment for Patients With Metastatic Triple-Negative Breast Cancer - Full Text View

Purpose

This multicenter, randomized, double-blind study will estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival in all patients and in patients with phosphatase and tensin homolog (PTEN)-low tumors. The safety and tolerability profile of ipatasertib combined with paclitaxel versus placebo combined with paclitaxel will be assessed.

Condition	Intervention	Phase
Breast Cancer	Drug: Ipatasertib Drug: Paclitaxel Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A RANDOMIZED, PHASE II, MULTI-CENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:

Progression-free survival (RECIST v1.1) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Confirmed objective tumor response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Duration of confirmed objective response in patients with measurable disease at baseline [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
Study Start Date:	August 2014
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	February 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Paclitaxel + Ipatasertib	Drug: Ipatasertib Administered orally 400 mg daily Days 1-21 of each 28-day cycle Other Name: GDC-0068
Active Comparator: Arm 2 Paclitaxel + Placebo	Drug: Paclitaxel 80 mg/m2 administered by IV infusion on Days 1, 8, and 15 of each cycle Drug: Placebo Administered orally daily Days 1-21 of each 28-day cycle

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
Premenopausal or postmenopausal women aged >/=18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1
Adequate hematologic and organ function within 14 days before the first study treatment
For female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment

Exclusion Criteria:

Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast
Patients may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed >/= 6 months prior to Cycle 1 Day 1
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Known HER2 positive, ER positive, or PR positive breast cancer
Previous therapy with Akt, PI3K, and/or mTOR inhibitors
Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
Known presence of the brain or spinal cord metastasis, as determined by CT or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162719

Contacts


Contact: Reference Study ID Number: GO29227 www.roche.com/about_roche/roche_worldwide.htm	888-662-6728 (U.S. and Canada)	global.rochegenentechtrials@roche.com

Show 64 Study Locations

Sponsors and Collaborators

Genentech, Inc.

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT02162719 History of Changes
Other Study ID Numbers:	GO29227 2014-000469-35
Study First Received:	June 11, 2014
Last Updated:	May 4, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel	Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016