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Terminated Phase 1Phase 2 Interventional Results available

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

ClinicalTrials.gov ID: NCT01132664

Public ClinicalTrials.gov record NCT01132664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

Study identification

NCT ID
NCT01132664
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
72 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2010 (Type not available)
Primary completion
Aug 2014 (Actual)
Completion
Aug 2014 (Actual)
Last update posted
Aug 17, 2016

2010 – 2014

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI Birmingham Alabama 35294-0006 —
Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville Arkansas 72703 —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida 33612 —
Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) Detroit Michigan 48201 —
Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman St Louis Missouri 63110 —
Beth Israel Medical Center BIMC New York New York 10003 —
Sarah Cannon Research Institute Sarah Cannon Cancer Center SC Nashville Tennessee 37203 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01132664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 17, 2016 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01132664 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →