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

Genentech

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Ipatasertib; Drug: Placebo; Drug: Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02301988

2014-003029-16 (EudraCT Number)

GO29505

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 2 patient groups, including a placebo group

Ipatasertib + Paclitaxel

Experimental group

Description:

Participants will receive ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses).

Treatment:

Drug: Paclitaxel

Drug: Ipatasertib

Placebo + Paclitaxel

Placebo Comparator group

Description:

Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses).

Treatment:

Drug: Placebo

Drug: Paclitaxel