A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.

Key facts

Study ID

NCT02301988

Run by

Genentech, Inc.

People needed

151

Starts

2015-02-17

Expected to finish

2017-08-02

Last updated by the study team

2018-10-17

Who can join

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

You may qualify if…

• Premenopausal or postmenopausal women
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI
• Adequate hematologic and organ function within 14 days before the first study treatment
• Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
• For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment

You may not qualify if…

• Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer
• Any prior treatment for the current primary invasive breast cancer
• Participants with cT4 or cN3 stage breast tumors
• Metastatic (Stage IV) breast cancer
• Bilateral invasive breast cancer
• Multicentric breast cancer
• Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications

Where it is running

• Arizona Oncology Associates, PC-CASA — Tucson, Arizona, United States
• Sansum Medical Clinic, Inc. — Santa Barbara, California, United States
• Rocky Mountain Cancer Center - Lakewood (West) — Lakewood, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mass General/North Shore Cancer — Danvers, Massachusetts, United States
• Nebraska Cancer Specialists; Oncology Hematology West, PC — Omaha, Nebraska, United States
• Carolinas Healthcare System — Charlotte, North Carolina, United States
• Northwest Cancer Specialists - Portland (NE Hoyt St) — Portland, Oregon, United States
• Roper Bon Secours St. Francis Cancer Center — Charleston, South Carolina, United States
• Texas Oncology — Austin, Texas, United States
• Texas Oncology Cancer Center — Austin, Texas, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology - Houston (Gessner) — Houston, Texas, United States
• Texas Oncology-Tyler — Irving, Texas, United States
• South Texas Cancer Center - McAllen — McAllen, Texas, United States
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States
• IPO de Lisboa; Servico de Oncologia Medica — Lisbon, Portugal
• Hospital Beatriz Angelo; Departamento de Oncologia — Loures, Portugal
• IPO do Porto; Servico de Oncologia Medica — Porto, Portugal
• Hospital Universitario Son Espases — Palma de Mallorca, Balearic Islands, Spain
• Hospital Son Llatzer; Servicio de Oncologia — Palma de Mallorca, Balearic Islands, Spain
• Hospital Provincial de Castellon; Servicio de Oncologia — Castellon, Castellon, Spain
• Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia — Santiago de Compostela, LA Coruña, Spain
• Hospital Universitari de Lleida Arnau de Vilanova — Lleida, Lerida, Spain
• Hospital Universitario Fundación Alcorcón — Alcorcón (Madrid), Madrid, Spain

Full record on ClinicalTrials.gov

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