BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off.
For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120.

Brain Metastases

Breast Cancer

Metastatic Breast Cancer

BKM120

capecitabine

Trastuzumab

Please contact Zuzanne Bristow for list of sites

STAR Cape+BKM120 MBC With Brain Met

Phase II Multicenter Single-arm Study of BKM120 Plus Capecitabine for Breast Cancer Patients With Brain Metastases

To determine the clinical benefit rate (CBR) based on local investigator assessment associated with BKM120 once daily plus capecitabine (1000 mg/m2 PO BID 14 days on/7 days off) in patients with metastatic breast cancer with a brain metastasis at least 5mm in size following whole brain radiation therapy (WBRT) and that has not progressed following WBRT. An exploratory analysis will be conducted of patients enrolled on study who have evidence of disease progression following WBRT. Clinical benefit rate is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) in the CNS lasting at least 24 weeks based on local investigator assessment.

To assess ORR associated with BKM120 plus capecitabine in the central nervous system based on local investigator assessment

To assess median time to progression (TTP) associated with BKM120 plus capecitabine.

To determine median overall survival (OS) associated with BKM120 plus capecitabine.

To characterize the safety and tolerability of BKM120 plus capecitabine, with or without trastuzumab

To assess median time to deterioration of neurologic function based on answers to questionnaires.

US Oncology Research

Novartis Pharmaceuticals

Paclitaxel will be given as an IV infusion at a dose of 80mg/m2 weekly x 12 weeks (4 cycles).

Cisplatin will be given by IV at 75 mg/m2 every 3 weeks, 4 cycles.

Triple Negative Breast Cancer

Cisplatin

Paclitaxel

University of Alabama

Indiana University- Simon Cancer Center

Johns Hopkins University

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

South Shore Hospital

Memorial Sloan Kettering Cancer Center-Basking Ridge

Memorial Sloan Kettering Cancer Center-Monmouth

Memorial Sloan Kettering Cancer Center-Commack

Memorial Sloan Kettering Cancer Center-West Harrison

Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center-Rockville Centre

Memorial Sloan Kettering Cancer Center-Sleepy Hollow

University of North Carolina- Lineberger Cancer Center

Duke University

Universtiy of Pittsburgh- Magee-Womens Hospital

Vanderbilt-Ingram Cancer Center

Baylor College of Medicine

Seattle Cancer Alliance at EvergreenHealth

University of Washignton

Cisplatin vs Paclitaxel for Triple Neg

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker

To compare the pathologic response to neoadjuvant platinum-based chemotherapy in TNBC with and without HR-deficiency, defined as a high HRD score or a BRCA mutation

To compare the pathologic response to neoadjuvant taxane-based chemotherapy in TNBC with and without HR-deficiency, defined as a high HRD score or a BRCA mutation

To evaluate whether the positive predictive value of HR-deficiency is greater for TNBC treated with cisplatin, as compared to TNBC treated with paclitaxel.

To determine the association of HR-deficiency with pathologic complete response (pCR) to neoadjuvant platinum-based chemotherapy in TNBC.

To determine the association of HR-deficiency with pCR to neoadjuvant taxane-based therapy in TNBC.

To evaluate clinical and pathologic responses in TNBC treated with preoperative cisplatin and paclitaxel.

To evaluate the performance of the HRD-LOH assay, the HRD-TAI assay, and the HRDLST assay, to predict pathologic response to cisplatin or taxane therapy in TNBC.

Erica Mayer, MD, MPH

Principal Invesitigator

Myriad Genetics, Inc.

Translational Breast Cancer Research Consortium

Doses of AUC 5-6 of carboplatin in combination with 75 mg/m2 of docetaxel are easily combined, being myelosuppression the most important toxicity. This combination has been studied in metastatic breast cancer as well as in the neoadjuvant setting. The combination of taxanes and platinum salts is increasingly used as neoadjuvant chemotherapy for TNBC. The docetaxel-carboplatin (TCb) regimen is an active and tolerable regimen in metastatic and locally advanced breast cancer, and the efficacy and toxicity characterization in the clinical setting are regaining interest in the era where the role of anthracyclines is controversial in the adjuvant setting. The avoidance of potentially serious long-term toxicities in specific breast cancer subtypes is a real challenge in an attempt to individualize therapies.

Breast Cancer Stage II-III

Docetaxel 75mg/m2 day 1 and Carboplatin(AUC6)day 1, each 21 days for 6 cycles.

Docetaxel- Carboplatin

Hospital Universitario Gregorio Marañon

Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer

The primary objective of the study is to identify predictors of response to docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined as lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR, pathological complete response).

To identify predictors of good pathological response according to Symmans criteria (i.e. Symmans class 0+1)
To identify predictors of chemoresistance (class III od Symmans)
To assess the clinical response rate by standard methods (MRI, clinical examination, mammogram) in patients treated with this regimen.
To evaluate breast conserving surgery rate in patients treated with this regimen.
To evaluate the pCR rate in patients with known BRCA mutations.

triple negative breast neoplasms/nausée

STAR Cape+BKM120 MBC With Brain Met

Cisplatin vs Paclitaxel for Triple Neg

Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer

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