Status:
COMPLETED
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
SOLTI Breast Cancer Research Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2017
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02301988
Start Date
February 17 2015
End Date
August 2 2017
Last Update
October 17 2018
Active Locations (42)
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1
Arizona Oncology Associates, PC-CASA
Tucson, Arizona, United States, 85704
2
Sansum Medical Clinic, Inc.
Santa Barbara, California, United States, 93105
3
Rocky Mountain Cancer Center - Lakewood (West)
Lakewood, Colorado, United States, 80228
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114