Abstract 36TiP
Background
Hormonal receptor-positive breast carcinoma constitutes the most common subtype of the disease. Neoadjuvant chemotherapy is the current standard of treatment for any locally advanced breast carcinoma. However, the hormone receptor-positive, Her-2 negative cancers are less likely to respond to neoadjuvant chemotherapy than other biologic subtypes. Studies have explored the efficacy of neoadjuvant hormone treatment in this cohort of patients and efforts are ongoing to identify the subgroup of patients who can be treated with hormonal therapy alone, hence avoiding the unnecessary toxicity of chemotherapy. Our study aims to assess the response to neoadjuvant hormonal therapy (NAHT) in the postmenopausal women who are considered to be low-risk subgroup and for whom chemotherapy can be safely avoided.
Trial design
Objectives Primary objective: To determine the clinical tumor response rate to NAHT. Secondary Objective: To assess the number of patients undergoing surgery and pCR rates. To assess biologic changes in the tumor, including hormonal receptor status and proliferation by Ki67 staining. Methods Type of study: Phase II Prospective single-center study. Patients: Postmenopausal women diagnosed with biopsy-proven, non-metastatic and potentially operable breast cancer. Inclusion Criteria: Clinical stage T3-T4c with node-negative or clinical stage T2-T4c with node-positive disease (N1, N2) ER-positive with Allred score 6-8, Her 2 negative and Ki67 < 14%. Exclusion Criteria: Past history of treatment for any other cancer, history of having received chemotherapy or use of hormone replacement therapy previously. Sample size: 35 patients. Study site and duration: Kidwai Cancer Institute, 1.5 years. Eligible patients will receive Neoadjuvant hormonal therapy with Aromatase inhibitor and will undergo regular monitoring of objective response rate using calipers at the time of diagnosis and monthly once. The response will be noted as per the WHO criteria. Progressive disease recorded at any time will lead to exclusion from the study and the patient will be started on chemotherapy. Toxicity assessment will be done regularly.
Clinical trial identification
Legal entity responsible for the study
Department of Medical Oncology, Kidwai Cancer Institute, Bengaluru.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
508P - Efficacy and safety of anti-PD-1 antibody SHR-1210 combined with apatinib in first-line treatment for advanced lung squamous carcinoma: A phase II study
Presenter: Jinliang Wang
Session: Poster display session
Resources:
Abstract
525P - Retrospective analysis of outcomes of cisplatin and irinotecan combination chemotherapy for unresectable thymic carcinoma
Presenter: Akito Fukuda
Session: Poster display session
Resources:
Abstract
524P - A study in recurrent small cell lung cancer patients, comparing weekly paclitaxel, irinotecan and temozolomide in second-line: A prospective study from a south Indian tertiary cancer hospital
Presenter: LALATENDU MOHARANA
Session: Poster display session
Resources:
Abstract
505P - PD-L1 expression in ALK rearranged NSCLC: All questions answered?
Presenter: Amrith B P
Session: Poster display session
Resources:
Abstract
487P - Afatinib versus gefitinib or erlotinib in first-line setting for Malaysia patients with EGFR mutant advanced lung adenocarcinoma
Presenter: Chee Shee Chai
Session: Poster display session
Resources:
Abstract
492P - Feasibility of rebiopsy and sequential treatment of EGFR tyrosine kinase inhibitors in real world patients with EGFR mutant non-small cell lung cancer
Presenter: Heekyung Ahn
Session: Poster display session
Resources:
Abstract
513P - Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed
Presenter: Shingo Kitagawa
Session: Poster display session
Resources:
Abstract
493P - Is exon 19 deletion different from exon 21 mutation in advanced non-small cell lung cancer: A single centre experience
Presenter: Sarita Shrivastva
Session: Poster display session
Resources:
Abstract
494P - Comparison of pattern of disease progression and prevalence of acquired T790M mutation in Malaysia patients with EGFR mutant lung adenocarcinoma upon failure of first-line afatinib, gefitinib and erlotinib
Presenter: Chee Shee Chai
Session: Poster display session
Resources:
Abstract
517P - High BRCA1 expression is independently correlated with decreased overall survival in lung adenocarcinoma: Evidence from meta and bioinformatics analyses
Presenter: Fengzhu Guo
Session: Poster display session
Resources:
Abstract