A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Breast cancer that is locally advanced or metastatic

• HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)

• A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization

• Adequate bone marrow and organ function

• Measurable or non-measurable disease

Exclusion Criteria:

• Prior chemotherapy for locally advanced or metastatic disease

• Previous treatment with PI3K or AKT inhibitors

• Patient has symptomatic CNS metastases

• Concurrent malignancy or malignancy within 3 years of study enrollment

• Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug

• Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent

• Active heart (cardiac) disease as defined in the protocol

• Known hypersensitivity or contraindications to use paclitaxel

• Pregnant or nursing (lactating) woman

• Certain scores on an anxiety and depression mood questionaire given at screening

• Other protocol defined criteria may apply