Two Arm, Multicentric, Randomized, Open Label, Parallel, Multiple Dose Study Subcutaneous Injection of Goserelin 3.6 Mg (Eurofarma) Vs ZOLADEX 3.6 Mg (AstraZeneca) Administered Subcutaneously in Premenopausal Patients with Breast Cancer.

Eurofarma Laboratorios S.A.1 site in 1 country6 target enrollmentOctober 30, 2020

ConditionsBreast Cancer

InterventionsGoserelin acetate 3.6 mg Injection ZOLADEX® 3.6mg Injection

DrugsGoserelin acetate 3.6 mg Injection ZOLADEX® 3.6mg Injection

Overview

Phase: Phase 3
Intervention: Goserelin acetate 3.6 mg Injection
Conditions: Breast Cancer
Sponsor: Eurofarma Laboratorios S.A.
Enrollment: 6
Locations: 1
Primary Endpoint: To evaluate and compare the pharmacodynamics
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.

Detailed Description

A phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with breast cancer

Registry

clinicaltrials.gov

Start Date

October 30, 2020

End Date

January 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Eurofarma Laboratorios S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pre-menopausal\* female patients of 18 to 59 years of age (both inclusive)
•\* Premenopausal female is defined by one of the following criteria: menstruating actively (\< 4 months since last menstrual period \[LMP\]) or between 4 and 12 months after LMP with a premenopausal FSH level; patients younger than 59 years of age who became amenorrheic while on adjuvant chemotherapy will be eligible only if the FSH level is in the premenopausal range (\<22.3 IU/litre). \[1\]
•BMI 18.5 to 30 kg/m2 (both inclusive).
•Patient with a confirmed diagnosis of early or advanced breast cancer (TNM stage I, II, III or stage IV or recurrent metastatic disease) who are scheduled to start goserelin therapy as per Investigator discretion.
•Hormone sensitivity (ER positive) of primary or secondary tumour tissue
•Patients with baseline estradiol levels \>30 pg/mL
•Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•Patients with life expectancy of at least 3 months as judged by the Investigator.
•Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.

Exclusion Criteria

•Patients who are not able to provide written informed consent.
•Patients who are menopausal
•Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
•Patients who are already on GnRH receptor agonist or antagonist therapy.
•Patients who have previously failed on GnRH receptor agonist or antagonist therapy for breast cancer treatment..
•Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree (proven or suspected) of brain or leptomeningeal involvement (past or present) or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of the disease.
•Patients who are intended to be started on any medication apart from study drug that can have impact on any of the study endpoints.
•Patients who are pregnant or breastfeeding.
•Concurrent malignancy or history of malignancy (apart from disease condition under study) within last 5 years before screening except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
•Patients with a clinically significant medical condition other than breast cancer including but not limited to renal, hepatic, gastrointestinal, endocrine, cardiovascular, neurological or psychiatric disease, alcohol or substance abuse, or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.