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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT02162719

Run by

Genentech, Inc.

People needed

124

Starts

2014-08-19

Expected to finish

2019-08-31

Last updated by the study team

2021-03-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St Jude Heritage Medical Group — Fullerton, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Cancer Care Assoc Med Group — Los Angeles, California, United States
• UCLA Medical Center — Santa Monica, California, United States
• Holycross Medical Group — Fort Lauderdale, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Carolinas Healthcare System — Charlotte, North Carolina, United States
• The WEST CLINIC, P.C. — Memphis, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Northern Utah Associates — Ogden, Utah, United States
• Northwest Medical Specialties — Lakewood, Washington, United States
• West Virginia University Hospitals Inc — Morgantown, West Virginia, United States
• Sint Augustinus Wilrijk — Wilrijk, Belgium
• Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest — Bordeaux, France
• Centre Francois Baclesse — Caen, France
• Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque — Montpellier, France
• Hopital Saint Louis; Oncologie Medicale — Paris, France
• Clinique Armoricaine de Radiol — Saint-Brieuc, France
• Istituto Nazionale Tumori Fondazione G. Pascale — Naples, Campania, Italy
• Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica — Milan, Lombardy, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.