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
175P - Hypermethylation of the PCDHB15 promoter predicts the prognosis in gastric cancer
Presenter: Yu-ting Lee
Session: Poster display session
Resources:
Abstract
176P - DCLK1 promotes tumour invasion and metastasis through epithelial-mesenchymal transition and the MEK/ERK pathway in esophageal squamous cell carcinoma
Presenter: Jiannan Yao
Session: Poster display session
Resources:
Abstract
177P - Comparison of nab-paclitaxel plus ramcirumab and paclitaxel plus ramcirumab in patients with pretreated metastatic gastric cancer
Presenter: Yosuke Horita
Session: Poster display session
Resources:
Abstract
178P - Chief cell in stomach have stem cell activity and potential to develop gastric cancer
Presenter: Akihiro Yamamura
Session: Poster display session
Resources:
Abstract
179P - Postoperative Adjuvant transarterial chemoembolization versus surgery alone for resected hepatocellular carcinoma: A propensity-score matching study
Presenter: Mingyu Chen
Session: Poster display session
Resources:
Abstract
180P - LHPP inhibit the cell proliferation and EMT via the TGFβ/SMAD3 signaling pathway in iCCA
Presenter: Dan Wang
Session: Poster display session
Resources:
Abstract
181P - The emerging role of third-line gemcitabine plus nab-paclitaxel in advanced pancreatic adenocarcinoma
Presenter: Andrew Dean
Session: Poster display session
Resources:
Abstract
182P - Durable response to second-line m-FOLFIRINOX for advanced pancreatic adenocarcinoma in patients with performance status of two or less
Presenter: Adarsh Das
Session: Poster display session
Resources:
Abstract
183P - Epidemiologic profile of gastric cancer in East Azerbaijan, Iran: 2 years population-based cancer registry results
Presenter: Pooneh Jabbaripour
Session: Poster display session
Resources:
Abstract
184P - Expression pattern of CDK12 protein in gastric cancer and its positive correlation with CD8+ cell density and CCL12 expression
Presenter: Jun Ji
Session: Poster display session
Resources:
Abstract