Breast Cancer Clinical Trial

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

Summary

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

View Eligibility Criteria

Eligibility 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
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 RECIST v1.1
Adequate hematologic and organ function within 14 days before the first study treatment
For female participants of childbearing potential, agreement (by both participant 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. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (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 computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

124

Study ID:

NCT02162719

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 44 Locations for this study

See Locations Near You

St Jude Heritage Medical Group
Fullerton California, 92835, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Cancer Care Assoc Med Group
Los Angeles California, 90095, United States
UCLA Medical Center
Santa Monica California, 90404, United States
Holycross Medical Group
Fort Lauderdale Florida, 33308, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89014, United States
Carolinas Healthcare System
Charlotte North Carolina, 28208, United States
The WEST CLINIC, P.C.
Memphis Tennessee, 38119, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Northwest Medical Specialties
Lakewood Washington, 98499, United States
West Virginia University Hospitals Inc
Morgantown West Virginia, 26056, United States
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux , 33076, France
Centre Francois Baclesse
Caen , 14076, France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
Montpellier , 34298, France
Hopital Saint Louis; Oncologie Medicale
Paris , 75475, France
Clinique Armoricaine de Radiol
Saint Brieuc , 22015, France
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica
Milano Lombardia, 20133, Italy
Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera
Padova Veneto, 35128, Italy
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre
Singapore , 16961, Singapore
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona , 08908, Spain
Complejo Hospitalario de Jaen
Jaen , 23007, Spain
MD Anderson Cancer Center
Madrid , 28033, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia
Madrid , 28050, Spain
Hospital Virgen del Rocio
Sevilla , 41013, Spain
China Medical University Hospital
North Dist. , 40402, Taiwan
Chi Mei Medical Center, Yong kang; Endocrinology
Tainan , 710, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

124

Study ID:

NCT02162719

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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