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Attend this session at the
2017 ASCO Annual Meeting!

Session: Breast Cancer—Metastatic

Type: Poster Session

Time: Sunday June 4, 8:00 AM to 11:30 AM

Location: Hall A

Session: Breast Cancer—Metastatic

Type: Poster Discussion Session

Time: Sunday June 4, 4:45 PM to 6:00 PM

Location: Hall B1

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).


Breast Cancer—Metastatic

2017 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #1)

J Clin Oncol 35, 2017 (suppl; abstr 1009)

Author(s): Rebecca Alexandra Dent, Sung-Bae Kim, Seock-Ah Im, Marc Espie, Sibel Blau, Antoinette R. Tan, Steven Isakoff, Mafalda Oliveira, Cristina Saura, Matthew Wongchenko, Amy V. Kapp, Wai Y. Chan, Stina M. Singel, Daniel J. Maslyar, Jose Baselga; Division of Medical Oncology, National Cancer Centre, Singapore, Singapore; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Seoul National University, Seoul, Republic of Korea; Hospital Saint Louis, Breast Disease Center, Paris, France; Northwest Medical Specialties, Puyallup, WA; Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC; Massachusetts General Hospital, Boston, MA; Vall d’Hebron University Hospital Institute of Oncology (VHIO), Barcelona, Spain; Genentech, Inc., San Francisco, CA; Memorial Sloan-Kettering Cancer Center, New York, NY

Abstract Disclosures


Background: The oral Akt inhibitor IPAT is being evaluated in cancers with a high prevalence of PI3K/Akt pathway activation, including TNBC. Methods: Eligible patients (pts) had measurable inoperable locally advanced/metastatic TNBC previously untreated with systemic therapy. Pts were stratified by prior (neo)adjuvant therapy, chemotherapy-free interval and tumor PTEN status, and randomized 1:1 to P 80 mg/m2 (d1, 8 & 15) with either IPAT 400 mg or PBO (d1–21) q28d until progression or unacceptable toxicity. Co-primary endpoints were progression-free survival (PFS) in the ITT population and pts with PTEN-low tumors by IHC. Secondary endpoints included objective response rate (ORR), duration of response (DoR) and overall survival in the ITT and IHC PTEN-low populations, efficacy in pts with PIK3CA/AKT1/PTEN-altered tumors by next-generation sequencing (NGS), and safety. Results: Baseline characteristics were generally balanced between arms. Efficacy is shown below. The most common grade ≥3 AEs (grouped terms) were diarrhea (23% IPAT+P vs 0% PBO+P; no grade 4 or colitis in either arm), neutropenia (18% vs 8%), asthenia (5% vs 6%), peripheral neuropathy (5% vs 5%) and pneumonia (5% vs 0%). More pts receiving IPAT+P than PBO+P had an AE leading to dose reduction of IPAT/PBO (21% vs 6%) or P (38% vs 11%) but median cumulative dose intensity was similar (IPAT/PBO: 99% vs 100%; P: 100% vs 100%). AEs led to IPAT/PBO discontinuation in 13% vs 11% of pts, respectively; 2 pts (3%) discontinued IPAT for grade 3 diarrhea. Conclusions: Adding IPAT to P for TNBC modestly improved PFS in the ITT pts. The effect was more pronounced in the prespecified subgroup with PIK3CA/AKT1/PTEN alterations, warranting further evaluation of IPAT in these pts. AEs were manageable. Clinical trial information: NCT02162719

PTEN low by IHC
PIK3CA/AKT1/PTEN-altered by NGS
    Events/pts (%)39/62 (63)45/62 (73)16/25 (64)18/23 (78)12/26 (46)13/16 (81)
    Median, mo6.
    HR (90% CI)0.60 (0.40–0.91)a0.68 (0.39–1.21)b0.44 (0.22–0.87)b
ORR, %403248265044
Median DoR, mo7.

aStratified, bUnstratified.

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. 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).

Meeting: 2017 ASCO Annual Meeting Abstract No: 1007 First Author: Nicholas C. Turner
Category: Breast Cancer—Metastatic - Triple-Negative


3. 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