A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
SOLTI Breast Cancer Research Group
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer