Status:
COMPLETED
NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Breast International Group
GBG Forschungs GmbH
Conditions:
HER2-positive Newly Diagnosed, Primary Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wil...
Detailed Description
NeoPHOEBE evaluated the efficacy (as defined by pCR) of BKM120 (an oral PI3K inhibitor) in combination with trastuzumab and paclitaxel in a randomized, placebo-controlled, neo-adjuvant study in women ...
Eligibility Criteria
Inclusion
- Patient had provided a signed study ICF prior to any screening procedure
- Patient was a female ≥ 18 years of age
- Patient has an ECOG performance status of 0-1
- Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer \>2cm by clinical examination and/or \>1.5 cm confirmed by ultrasound or by MRI
- Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status
- Patient has adequate bone marrow, renal and liver function
- Patient is able to swallow and retain oral medication
Exclusion
- Patient has received prior systemic treatment for currently diagnosed disease
- Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor
- Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer
- LVEF below 50% as determined by MUGA scan or ECHO
- Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol
- Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
- Patient is currently receiving warfarin or other coumarin derived anti-coagulants
- Patient is currently receiving chronic treatment with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed)
- Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A
- Patient has certain scores on an anxiety and depression mood questionnaires
- Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
Key Trial Info
Start Date :
September 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01816594
Start Date
September 3 2013
End Date
February 18 2015
Last Update
November 14 2019
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Parkville, Victoria, Australia, 3002
2
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
3
Novartis Investigative Site
Salzburg, Austria, 5020
4
Novartis Investigative Site
Lübeck, Germany, 23538