Terminated PHASE1/PHASE2 INTERVENTIONAL 5-arm NCT01918306

GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer

A Phase Ib/II Trial of GDC-0941 (a PI3K Inhibitor) in Combination With Cisplatin in Patients With Androgen Receptor Negative Triple Negative Metastatic Breast Cancer

Sponsor: Genentech, Inc.

Conditions Estrogen Receptor Negative Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Recurrent Breast Cancer Stage IV Breast Cancer Triple Negative Breast Cancer Triple-negative Breast Cancer

Interventions GDC -0941 cisplatin dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI laboratory biomarker analysis pharmacological study

Updated 8 times since 2017 Last updated: May 22, 2017 Started: Sep 30, 2013 Primary completion: Dec 31, 2014 Completion: Apr 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

company stopped production of study drug due to excessive toxicities, lack of efficacy

Other terminated trials from Genentech, Inc.

More terminations from Genentech, Inc.

A PHASE1/PHASE2 clinical study on Estrogen Receptor Negative Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, this trial is terminated or withdrawn. The trial is conducted by Genentech, Inc. and has accumulated 8 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE1/PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Jan 2021 — Jul 2024 [monthly]

Terminated PHASE1_PHASE2
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE1_PHASE2

▶ Show 3 earlier versions

Aug 2017 — Jun 2018 [monthly]

Terminated PHASE1_PHASE2
Feb 2017 — Aug 2017 [monthly]

Terminated PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE1_PHASE2

First recorded

Sep 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genentech, Inc.
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center

Data source: Vanderbilt-Ingram Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Baltimore, United States , Birmingham, United States , Boston, United States , Charlotte, United States , Chicago, United States , Houston, United States , Indianapolis, United States , Nashville, United States and 6 more locations