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

NCT02301988 ↗

Phase 2 Completed 151 enrolled Genentech, Inc. SOLTI Breast Cancer Research Group · collab

RandomizedParallel-groupDouble-blindTreatment

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 combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.

Timeline

Start: 2015-02-17
Primary completion: 2017-08-02
Completion: 2017-08-02

Outcome

Missed primary endpoint

registry analysis (superiority test); Ipatasertib + Paclitaxel vs Placebo + Paclitaxel; p = 0.519; Difference in Response Rates 3.77 (95% CI -8.99 to 16.54); Chi-squared NCT02301988 ↗

registry analysis (superiority test); Ipatasertib + Paclitaxel vs Placebo + Paclitaxel; p = 0.7817; Difference in response rates 3.29 (95% CI -25.52 to 32.10); Chi-squared NCT02301988 ↗

Publications

Oliveira M, Saura C, Nuciforo P, Calvo I, Andersen J, Passos-Coelho JL, Gil Gil M, Bermejo B, Patt DA, Ciruelos E, de la Pena L, Xu N, Wongchenko M, Shi Z, Singel SM, Isakoff SJ. FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer. Ann Oncol. 2019 Aug 1;30(8):1289-1297. doi: 10.1093/annonc/mdz177.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipatasertib	Small molecule	400 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous