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
98P - Influence of DPYD*9, DPYD*6 and GSTP1 ile105val genetic polymorphisms on capecitabine and oxaliplatin (CAPOX) associated toxicities in colorectal cancer patients
Presenter: Ashok Varma
Session: Poster display session
Resources:
Abstract
99P - Patient-derived tumour model by new culture method leading to the precision medicine
Presenter: Norikatsu Miyoshi
Session: Poster display session
Resources:
Abstract
100P - Clinical impact and carcinogenic mechanism of NCAPG overexpression in colon cancer
Presenter: Kai-Yuan Lin
Session: Poster display session
Resources:
Abstract
101P - Combined cellular immunotherapy and chemotherapy improves clinical outcome and displays safety in the treatment of patients with colorectal cancer
Presenter: Chang Wang
Session: Poster display session
Resources:
Abstract
102P - Clinical features of anorectal cancer in patients with Crohn’s disease: Japanese single center study
Presenter: Kazuhiro Watanabe
Session: Poster display session
Resources:
Abstract
103P - Contrast-enhanced CT-based textural parameters as potential prognostic factors of survival for colorectal cancer patients receiving targeted therapy
Presenter: Yanfei Yang
Session: Poster display session
Resources:
Abstract
104P - Prognostic significance of tumour location to the oncologic outcome of colon cancer
Presenter: Sare Hosseini
Session: Poster display session
Resources:
Abstract
105P - Detection and clinical significance of circulating tumour cells in patients with rectal cancer
Presenter: Shuohui Dong
Session: Poster display session
Resources:
Abstract
106P - The risk of malignization incidence in patients with polyps and polyposis of the colon and rectum
Presenter: Yakov Ten
Session: Poster display session
Resources:
Abstract
107P - The efficacy of adjuvant chemotherapy according to the risk classification of recurrence based on the systemic inflammatory markers in patients with colorectal cancer liver metastases
Presenter: Masatsune Shibutani
Session: Poster display session
Resources:
Abstract