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Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast Cancer by Felipe Batalini; Niya Xiong; Nabihah Tayob; Madeline Polak; Julia Eismann; Lewis C. Cantley; Geoffrey I. Shapiro; Viktor Adalsteinsson; Eric P. Winer; Panagiotis A. Konstantinopoulos; Alan D'Andrea; Elizabeth M. Swisher; Ursula A. Matulonis; Gerburg M. Wulf; Erica L. Mayer is a Medicine article available to read on EtoBox.
What is Phase 1b Clinical Trial with Alpelisib plus Olaparib for Patients with Advanced Triple-Negative Breast Cancer about?
## Abstract ## Purpose: We had previously reported on the safety and the recommended phase 2 dose (RP2D) of olaparib in combination with the PI3Kα-specific inhibitor alpelisib in patients with high-grade serous ovarian cancer as studied in a phase 1b trial (NCT01623349). Here, we report on the breast cancer cohort from that study. ## Patients and Methods: Eligible patients had recurrent triple-negative breast cancer (TNBC) or recurrent breast cancer of any subtype with a germline BRCA mutation and were enrolled to a dose-escalation or -expansion cohort. After definition of the RP2D, secondary end points included safety and objective response rate (ORR). Exploratory analyses were performed using circulating-free DNA (cfDNA). ## Results: Seventeen patients with TNBC were enrolled with a median of three prior lines of chemotherapy. The most common treatment-related grade 3–4 adverse events were hyperglycemia (18%) and rash (12%). The ORR was 18% (23% for patients treated at the RP2D) and 59% had disease control. The median duration of response was 7.4 months. Analysis of cfDNA tumor fractions (TFx) revealed that patients with TFx < 15% after completion of the first cycle had a longer
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- Author
- Felipe Batalini; Niya Xiong; Nabihah Tayob; Madeline Polak; Julia Eismann; Lewis C. Cantley; Geoffrey I. Shapiro; Viktor Adalsteinsson; Eric P. Winer; Panagiotis A. Konstantinopoulos; Alan D'Andrea; Elizabeth M. Swisher; Ursula A. Matulonis; Gerburg M. Wulf; Erica L. Mayer
- Publisher
- American Association for Cancer Research (AACR)
- Published
- 2022
- Language
- EN
- Field
- Medicine (Health Sciences)