Clinico-pathological features and prognosis of patients with pregnancy associated breast cancer: A matched case control study

abstracts

Kong). N. Kleinman: Research grant / Funding (institution): Amgen Asia Holding Limited (Hong Kong). J. Lange: Research grant / Funding (institution): Amgen Inc., Thousand Oaks, CA, USA. T.C. Lin: Research grant / Funding (institution): Amgen Inc., Thousand Oaks, CA, USA. All other authors have declared no conflicts of interest.

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Clinico-pathological features and prognosis of patients with pregnancy associated breast cancer: A matched case control study

R. Zhang, X.-R. Liu, H. Li Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China Background: The impact of pregnancy on clinico-pathological features and prognosis of breast cancer remains controversial.We aimed to evaluate the impact of the association of pregnancy with breast cancer on tumor feature and prognosis- overall survival (OS) and disease free survival (DFS). Methods: We defined Pregnancy Associated Breast Cancer (PABC) as breast cancer diagnosed during pregnancy or within a year following delivery. We enrolled PABC patients(pts) treated at our institution between December 2012 and December 2017 , and for each case, one non-PABC control was matched for stage, age, and year of diagnosis. Chis-quare and Fisher’s exact test, the Kaplan-Meier method, and Cox’s regression model were used. Univariate and multivariate analyses were performed to assess the parameters associated with prognosis. Results: 41 women with PABC were identified; 22 pts were diagnosed during pregnancy and 19 were diagnosed within one year of postpartum. There were more PR negative and triple negative tumors in the PABC(56.1% and 24.4%) than in the nonPABC(31.7% and 4.9%) (p ¼ 0.045 and 0.026 respectively). The HER2 positivity was the same in the two group, both 31.7%. Median DFS in PABC pts was 29.0 months (95% CI range 6.5-51.5 months ) compared with 40.9 months (95% CI range 22.8–58.8 months) in the non-PABC pts(p ¼ 0.167). Median OS in two groups were similar and even longer in PABC group, 82.8 months in PABC pts range(95% CI 39.3126.5months) compared with 80.1 months (95% CI range 56.7-103.6months) in the non-PABC pts( p ¼ 0.131). Conclusions: The results show histological features were similar in both groups, except that triple-negative tumors were more common in the PABC group. The survival analyses show similar OS for patients diagnosed with PABC compared with non-PABC patients, and DFS tends to be shorter for PABC but no significant difference was observed. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

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TRYbeCA-2: A randomized phase II/III study of eryaspase in combination with gemcitabine and carboplatin chemotherapy versus chemotherapy alone as first-line treatment in patients with metastatic or locally recurrent triple-negative breast cancer

A.H. Awada1, J. Corte´s2, S. Slater3, I. Macpherson3, T. Csoszi4, J.-B. Bertrand5, A.S. Clermont5, R. Pollard6, R. Chrestia-Blanchine5, N. Biswas-Baldwin5, H. Youssoufian6, I. El-Hariry6 1 Department of Medicine, Institute Jules Bordet, Brussels, Belgium, 2Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain, 3Medical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, UK, 4Oncology Department, Hetenyi Geza Korhaz, Onkologiai Kozpont, Szolnok, Hungary, 5Oncology Department, Erytech Pharma, Lyon, France, 6Oncology Department, Erytech Pharma, Boston, MA, USA Background: Triple Negative Breast Cancer (TNBC) represents approximately 15% of all breast cancer. It confers a poorer prognosis relative to the other breast cancer subtypes, with an increased likelihood of recurrence and death within 5 years of diagnosis. There is no standard of care specifically for patients presenting with TNBC. Altered amino acid metabolism have been shown to play a role in TNBC. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. In a recent randomized phase 2b study, eryaspase has demonstrated evidence of improved overall

v138 | Breast Cancer, Metastatic

survival (OS) and progression free survival (PFS) and acceptable safety when combinedwith gemcitabine or FOLFOX therapyinpatients with advanced pancreatic cancer whose disease progressed following first-line treatment (NCT02195180). The demonstration of ASNase activity of eryaspase in combination with chemotherapy including DNA-damaging agents in both preclinical and clinical settings provide a rationale to further test combination in TNBC. Trial design: TRYbeCA-2 is an international, randomized, open-label phase 2/3 trial (N ¼ 64 for phase 2) of eryaspase combined with chemotherapy in patients with locally recurrent or metastatic TNBC who have not received prior systemic therapy for locally recurrent or metastatic disease. Patients are randomized in a 1:1 ratio to receive gemcitabine/carboplatin with or without eryaspase, administered as IV infusion on Day 1 and Day 8 of each 3-week cycle. Key eligibility criteria include measurable lesion(s), performance status 0 or 1, and adequate organ function. The primary endpoint is the objective response rate (ORR) as determined by an independent radiological review. Key secondary endpoints include ORR as determined by the investigator’s assessment, clinical benefit rate, overall survival, progression-free survival, safety, biomarker research, pharmacokinetics and pharmacodynamics. Clinical trial identification: NCT03674242. Legal entity responsible for the study: Erytech. Funding: Erytech. Disclosure: J. Bertrand: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. A. Clermont: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. R. Pollard: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. R. Chrestia-Blanchine: Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. N. Biswas-Baldwin: Leadership role, Shareholder / Stockholder / Stock options, Full / Parttime employment: Erytech. I. El-Hariry: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: Erytech. All other authors have declared no conflicts of interest.

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CONTESSA TRIO: A multinational, multicenter, phase II study of tesetaxel plus 3 different PD-(L)1 inhibitors in patients with metastatic triple negative breast cancer (TNBC) and tesetaxel monotherapy in elderly patients with her2- metastatic breast cancer (MBC)

S.M. Tolaney1, J.L. Blum2, I. Bondarenko3, A. Chan4, N. DaCosta5, Y.-H. Feng6, Y. Izarzugaza7, S.-B. Kim8, M.-C. Liu9, M. Oliveira10, S.G.W. Ow11, M. Pavic12, M.E. Pere´z Lope´z13, H.S. Rugo14, L. Schwartzberg15, A. Stradella16, S. Kroll17, J. O’Connell18, T. Wei17, E.A. Mittendorf19 1 Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA, 2Medical Oncology, Texas Oncology - Baylor Sammons Cancer Center, Dallas, TX, USA, 3Oncology and Medical Radiology Department, City Clinical Hospital n. 4, Dnipro, Ukraine, 4Oncology, Breast Cancer Research Centre BCRC - WA, Nedlands, Australia, 5Oncology, North Shore Hematology Oncology Associates, East Setauket, NY, USA, 6Hematology and Medical Oncology, Chi Mei Medical Center, Tainan, Taiwan, 7Medical Oncology, Hospital Universitario Fundaci on Jime´nez Dıaz, Madrid, Spain, 8Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea, 9 Hematology and Medical Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan, 10Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, 11Haematology-Oncology, National University Cancer Institute, Singapore, 12Hemato-oncology, Centre Hospitalier Universitaire de Sherbrooke, na Universitary Hospital, La Coru~ na, Sherbrooke, QC, Canada, 13Oncology, A Coru~ Spain, 14Medicine, University of California San Francisco Comprehensive Cancer Center, 15 San Francisco, CA, USA, Oncology, West Cancer Center, Germantown, TN, USA, 16 Medical Oncology, Institut Catal a d’Oncologia, Barcelona, Spain, 17Research and Development, Odonate Therapeutics, Inc., San Diego, CA, USA, 18Medical and Clinical Affairs, Odonate Therapeutics, Inc., San Diego, CA, USA, 19Surgical Oncology, Brigham and Wome ns Hospital, Boston, MA, USA Background: Chemotherapy (CT) treatments with robust efficacy that preserve quality of life are needed. Tesetaxel (T) is a novel, oral taxane that has potential advantages over currently available taxanes, including: oral administration with a low pill burden and once every 3 week (Q3W) dosing; no observed hypersensitivity reactions; and preclinical evidence of central nervous system (CNS) penetration and improved activity against CT-resistant tumors. More than 600 pts have been treated with T in clinical studies. T had robust monotherapy activity in a phase 2 study in 38 pts with HER2-, HRþ MBC, with a confirmed objective response rate (ORR) per RECIST 1.1 of 45%. Trial design: CONTESSA TRIO is a 2-cohort, multinational, multicenter, Phase 2 study. In Cohort 1, 90 pts (with potential expansion to up to 150 pts) with metastatic TNBC who have not received prior CT for advanced disease will be randomized 1:1:1 to receive T at 27 mg/m2 Q3W plus either: (1) nivolumab at 360 mg Q3W; (2) pembrolizumab at 200 mg Q3W; or (3) atezolizumab at 1,200 mg Q3W. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are approved for the treatment of multiple types of cancer; atezolizumab, in combination with nabpaclitaxel, was recently approved in the U.S. for the treatment of metastatic TNBC. The dual primary endpoints for Cohort 1 are ORR and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the 3 PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the 3 approved PD-L1 diagnostic assays. CONTESSA TRIO is the first randomized clinical study to compare 3 approved PD(L)1 inhibitors. In Cohort 2, 40 elderly pts (with potential expansion to up to 60 pts) with HER2- MBC who have not received prior CT for advanced disease will receive T monotherapy at 27 mg/m2 Q3W. The primary endpoint for Cohort 2 is ORR.

Volume 30 | Supplement 5 | October 2019

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most prevalent BTA used was denosumab (7.7%) in Taiwan and zoledronate in Hong Kong (3.7%) and Korea (1.8%). Denosumab was not available in Korea during the study period. The mean duration of BTA use was 111 (SD 154) days in Taiwan, 110 (SD 148) in Hong Kong and 133 (SD 188) days in Korea. Conclusions: In this first analysis reporting on treatment patterns for BTA use in Asia, the results suggest variation in BTA use among places and a shorter treatment duration of BTA use in clinical practice compared with guideline recommendations. The study provided fundamental information for subsequent evaluations of how this variation in BTA use may be associated with optimal clinical outcomes in Asia. Legal entity responsible for the study: School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Funding: Amgen Asia Holding Limited (Hong Kong). Disclosure: S.N. Gao: Research grant / Funding (institution): Amgen Asia Holding Limited (Hong

Annals of Oncology