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2017 ASCO Annual Meeting!

Session: Breast Cancer—Metastatic

Type: Oral Abstract Session

Time: Saturday June 3, 1:15 PM to 4:15 PM

Location: Hall D1

Final results of a phase 2 study of talazoparib (TALA) following platinum or multiple cytotoxic regimens in advanced breast cancer patients (pts) with germline BRCA1/2 mutations (ABRAZO).


Breast Cancer—Metastatic

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 1007)

Author(s): Nicholas C. Turner, Melinda L. Telli, Hope S. Rugo, Audrey Mailliez, Johannes Ettl, Eva-Maria Grischke, Lida A. Mina, Judith Balmana Gelpi, Peter A. Fasching, Sara A. Hurvitz, Andrew M. Wardley, Colombe Chappey, Wendy Verret, Alison L. Hannah, Mark E. Robson; Royal Marsden Hospital, The Institute of Cancer Research, London, United Kingdom; Stanford University Medical Center, Stanford, CA; University of California San Francisco Comprehensive Cancer Center, San Francisco, CA; Centre Oscar Lambret, Lille, France; Klinikum Rechts der Isar, Technische Universität München, Munich, Germany; Universitӓts-Frauenklinik Tubingen, Eberhard Karls University, Tubingen, Germany; Banner Health, Phoenix, AZ; Hospital Vall d’Hebron, Barcelona, Spain; University of Erlangen, Erlangen, Germany; University of California Los Angeles Health, Santa Monica, CA; The Christie Hospital, Huddersfield, United Kingdom; Medivation, Inc., San Francisco, CA; Memorial Sloan-Kettering Cancer Center, New York, NY

Abstract Disclosures


Background: TALA is a dual-mechanism PARP inhibitor that traps PARP on DNA. This study was designed to assess the activity of TALA in pts with gBRCA1/2mutation previously exposed to platinum or multiple prior cytotoxic regimens. Methods: ABRAZO (NCT02034916) is a 2-cohort, 2-stage phase 2 study of TALA (1 mg/d) following platinum-based therapy (Cohort 1 [C1]) or ≥ 3 platinum-free cytotoxic-based regimens (Cohort 2 [C2]) in pts with locally advanced or metastatic breast cancer (MBC) and gBRCA1/2mutation. Pts had ECOG PS ≤ 1 and measurable disease by RECIST v1.1. Five responses per cohort were required in ≤ 35 pts to progress to stage 2. The primary endpoint was confirmed ORR by independent radiology facility (IRF). Secondary endpoints: clinical benefit rate ≥ 24 weeks (CBR24), DOR, PFS, and OS. Results: From May 2014 to Feb 2016, 84 pts were enrolled (C1, n = 49; C2, n = 35). At data cutoff (1 Sep 2016), 9 pts continued on treatment. Both cohorts proceeded to stage 2 before enrollment closed. Median age was 50 (range, 31–75) years; 58% of pts had an ECOG PS of 0. TNBC/HR+ incidence in C1 and C2 was 59%/41% and 17%/83%, respectively. Median number of prior cytotoxic regimens administered for advanced disease was 2 in C1 and 4 in C2. ORR by IRF for BRCA1/BRCA2 was 24%/34%, and ORR by IRF for TNBC/HR+ was 26%/29%. Common all grade AEs: anemia (52%), fatigue (45%), nausea (42%), diarrhea (33%), thrombocytopenia (33%), and neutropenia (27%). Grade ≥ 3 AEs: anemia (35%), thrombocytopenia (19%), and neutropenia (15%). Nonhematological AEs grade ≥ 3 did not occur. AEs related to TALA led to drug discontinuation in 3 pts (4%); 4 AEs resulted in death, none related to TALA. Conclusions: TALA was well tolerated in MBC pts with a gBRCA1/2 mutation, exhibiting promising antitumor activity in C1 and C2. TALA vs physician’s choice of treatment in gBRCA1/2-mutated MBC is being evaluated in the phase 3 EMBRACA trial (NCT01945775). Clinical trial information: NCT02034916

C1 (n = 48)C2 (n = 35)
ORR by IRF, n (% [95% CI])10 (21% [10, 35])13 (37% [21, 55])
DOR by IRF, mo (95% CI)5.8 (2.8, not reached)3.8 (2.8, 10.1)
CBR24 by INV, n (% [95% CI])18 (38% [24, 53])23 (66% [48, 81])
PFS by INV, mo (95% CI)4.0 (2.8, 5.4)5.6 (5.5, 7.8)

Other Abstracts in this Sub-Category:


1. Association of a four-gene decision tree signature with response to platinum-based chemotherapy in patients with triple negative breast cancer.

Meeting: 2017 ASCO Annual Meeting Abstract No: 1006 First Author: Jelmar Quist
Category: Breast Cancer—Metastatic - Triple-Negative


2. Phase 2 study of pembrolizumab (pembro) monotherapy for previously treated metastatic triple-negative breast cancer (mTNBC): KEYNOTE-086 cohort A.

Meeting: 2017 ASCO Annual Meeting Abstract No: 1008 First Author: Sylvia Adams
Category: Breast Cancer—Metastatic - Triple-Negative


3. LOTUS (NCT02162719): A double-blind placebo (PBO)-controlled randomized phase II trial of first-line ipatasertib (IPAT) + paclitaxel (P) for metastatic triple-negative breast cancer (TNBC).

Meeting: 2017 ASCO Annual Meeting Abstract No: 1009 First Author: Rebecca Alexandra Dent
Category: Breast Cancer—Metastatic - Triple-Negative