Phase 3
Completed N=416
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
Source: ClinicalTrials.gov NCT01572727 ↗Enrolled (actual)
416
Serious AEs
25.6%
Results posted
Jan 2017
Primary outcomePrimary: Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll) — 8.0; 9.2 Months
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll) |
8.0; 9.2 | — |
| SECONDARY Overall Survival by Kaplan-Meier Estimate (Phase ll) |
29.5; NA | — |
| SECONDARY Overall Response Rate (Phase ll) |
22.6; 27.1 | — |
| SECONDARY Duration of Response (Phase Lll) |
— | — |
| SECONDARY Time to Response (Phase Lll) |
— | — |
| SECONDARY Clinical Benefit Rate (CBR) (Phase ll) |
26.2; 32.9 | — |
| SECONDARY Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll) |
— | — |
| SECONDARY Time to Definitive Deterioration of ECOG Performance Status (Phase Lll) |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01572727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.