Spots Global Cancer Trial Database for Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients

Study Description

Brief Summary: Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.

Detailed Description: Patients will be randomized into two groups: The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines. The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients. * Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients. * All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery. * We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. * Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group. * Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment. * Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0. * Surgery will be performed between the 24th and 26th week. * Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A. The primary endpoint will be; * The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements. * A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1. Secondary endpoints will be; * The rate of pathological complete response (pCR). * The rate of breast conservation surgery. * Ki-67 changes. * The length of time to maximum response within a treatment period. * The Adverse events associated with each treatment arm.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial