CTRI/2020/02/023101
Not yet recruiting
Phase 3
A phase III, two arm, multicentric, randomized, open label, parallel, multiple dose pharmacodynamics study of Goserelin 3.6 mg Injection (Eurofarma Laboratorios S. A.) administered subcutaneously in comparison with the reference drug ZOLADEX® 3.6 mg Injection (AstraZeneca) administered subcutaneously in premenopausal patients with advanced Breast cancer.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Sponsor
- Eurofarma Laboratorios SA
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Pre\-menopausal female patients of 18 to 50 years of age (both inclusive).
- •2\. BMI 18\.5 to 30 kg/m2 (both inclusive).
- •3\. Patient with a confirmed diagnosis of advanced breast cancer (TNM stage III or
- •stage IV or recurrent metastatic disease) who are scheduled to start goserelin
- •therapy as per Investigator discretion.
- •4\. Hormone sensitivity (ER positive) of primary or secondary tumour tissue
- •5\. Patients with baseline estradiol levels \>30 pg/mL
- •6\. 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.
- •7\. Eastern Cooperative Oncology Group (ECOG) performance status \<\= 2\.
- •8\. Patients with life expectancy of at least 3 months as judged by the Investigator.
Exclusion Criteria
- •1\. Patients who are not able to provide written informed consent.
- •2\. Patients who are menopausal.
- •3\. Patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.
- •4\. Patients who are already on GnRH receptor agonist or antagonist therapy.
- •5\. Patients who have previously failed on GnRH receptor agonist or antagonist therapy.
- •6\. 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.
- •7\. Patients who are intended to be started on any medication apart from study drug that can have impact on any of the study endpoints.
- •8\. Patients who are pregnant or breastfeeding.
- •9\. Concurrent malignancy or history of malignancy (apart from disease condition
Outcomes
Primary Outcomes
Not specified
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