Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2014-05-19
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria (phase lb):

• Females with Breast cancer that is histologically or cytologically confirmed, HER2 negative and locally advanced or metastatic as confirmed by radiology

• ECOG performance status 0 and 1

• Adequate bone marrow and organ function

Exclusion Criteria (Phase lb):

• Previous treatment with PI3K and/or mTOR inhibitors

• Symptomatic Central Nervous System (CNS) metastases

• Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment

• Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug

• Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF > 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)

• Inadequately controlled hypertension

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 and/or paclitaxel

• Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists

• Sensitivity to paclitaxel treatment

• Uncontrolled diabetes mellitus

• Pregnant or nursing (lactating) woman

Other protocol-defined inclusion/exclusion criteria may apply