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 (BELLE-4)

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Drug: BKM120; Drug: BKM120 matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572727

2011-005932-24 (EudraCT Number)

CBKM120F2202

Details and patient eligibility

About

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.

Full description

Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.

Enrollment: 416 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 2 patient groups

BKM120 and paclitaxel

Experimental group

Description:

Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.

Treatment:

Drug: BKM120

Drug: Paclitaxel

Placebo and paclitaxel

Active Comparator group

Description:

Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.

Treatment:

Drug: BKM120 matching placebo

Drug: Paclitaxel