Terminated PHASE1 INTERVENTIONAL 1-arm NCT01238133

Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage II or Stage III Triple-Negative Breast Cancer

A Phase 1 Study of Neoadjuvant Chemotherapy With the Gamma Secretase Inhibitor RO4929097 in Combination With Paclitaxel and Carboplatin in Patients With Clinical Stage II-III Triple Negative Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-Negative Breast Carcinoma

Interventions Carboplatin Gamma-Secretase Inhibitor RO4929097 Laboratory Biomarker Analysis Paclitaxel Pharmacological Study Therapeutic Conventional Surgery

Updated 6 times since 2017 Last updated: Sep 3, 2015 Started: Dec 31, 2010 Primary completion: Jan 31, 2014 Completion: Aug 31, 2015

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

Terminated

This trial was terminated. No reason was provided.

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Other Estrogen Receptor Negative trials with similar outcome

Browse all Estrogen Receptor Negative trials

This PHASE1 trial investigates Estrogen Receptor Negative and HER2/Neu Negative and is currently terminated or withdrawn. National Cancer Institute (NCI) leads this study, which shows 6 recorded versions since 2010 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Terminated PHASE1
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE1
Jan 2021 — Jul 2024 [monthly]

Terminated PHASE1
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE1
Feb 2017 — Jun 2018 [monthly]

Terminated PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Terminated PHASE1

First recorded

Dec 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

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

Study Locations

• Columbus, United States