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
52P - Reverse Warburg effect-related mitochondrial activity and 18F-FDG uptake in invasive ductal carcinoma
Presenter: Byung Wook Choi
Session: Poster display session
Resources:
Abstract
53P - Phase II study of atorvastatin in combination with radiotherapy and temozolomide in patients with glioblastoma (ART): Final analysis report
Presenter: Abdullah Altwairgi
Session: Poster display session
Resources:
Abstract
54P - Association between Parkinson’s disease and brain tumours: A nationwide population-based cohort study
Presenter: Joo-hyun Park
Session: Poster display session
Resources:
Abstract
55P - Toxicity profiles of treatment with modern fractionated radiotherapy, contemporary stereotactic radiosurgery, or transsphenoidal surgery in non-functioning pituitary macroadenoma
Presenter: Kevin Sheng-Po Yuan
Session: Poster display session
Resources:
Abstract
56P - Hippocampal avoidance in WBRT for metastases: Comparative neurocognitive and dosimetric assessment
Presenter: Vibhay Pareek
Session: Poster display session
Resources:
Abstract
57P - Multidisciplinary brain metastasis clinic: Is it effective and worthwhile?
Presenter: Annu Rajpurohit
Session: Poster display session
Resources:
Abstract
58P - Functional status as a determinant prognostic factor for overall survival in adult patients with medulloblastoma treated with chemotherapy and radiotherapy
Presenter: Juan Ayala Alvarez
Session: Poster display session
Resources:
Abstract
59P - Pattern of care in high-grade gliomas after recurrence
Presenter: Nandini Menon
Session: Poster display session
Resources:
Abstract
60P - Five fractions plus “SRS” boost combined with temozolamide for newly diagnosed and recurrent glioblastoma multiforme (GBM)
Presenter: Azhar Rashid
Session: Poster display session
Resources:
Abstract
64P - Entrectinib in locally advanced/metastatic ROS1 and NTRK fusion-positive non-small cell lung cancer (NSCLC): Updated integrated analysis of STARTRK-2, STARTRK-1 and ALKA-372-001
Presenter: Filippo de Braud
Session: Poster display session
Resources:
Abstract