A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/19/2018 |
Start Date: | February 17, 2015 |
End Date: | August 2, 2017 |
A Phase II Randomized, Double-Blind, Study of Ipatasertib (GDC-0068), an Inhibitor to AKT, in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
17
sites
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2095 Henry Tecklenburg Drive
Charleston, South Carolina 29414
Charleston, South Carolina 29414
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5050 Northeast Hoyt Street
Portland, Oregon 97213
Portland, Oregon 97213
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