Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer

NCT03936933 | Terminated Phase 3 DMC

• 1 other identifier: EF 160
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate and compare the pharmacodynamics

  Percentage of patients with a mean estradiol concentration \<30 pg/mL at day 85 days (EOS)

  85 days

Study Arms (2)

Goserelin acetate 3.6 mg Injection

EXPERIMENTAL

3.6 mg, Subcutaneously at every 28 days

Drug: Goserelin acetate 3.6 mg Injection

ZOLADEX® 3.6mg Injection.

ACTIVE COMPARATOR

3.6 mg, Subcutaneously at every 28 days

Drug: ZOLADEX® 3.6mg Injection

Interventions

Goserelin acetate 3.6 mg Injection DRUG

3.6 mg, Subcutaneously at every 28 days

Also known as: Goserelin acetate

Goserelin acetate 3.6 mg Injection

ZOLADEX® 3.6mg Injection DRUG

3.6 mg, Subcutaneously at every 28 days

Also known as: Zoladex

ZOLADEX® 3.6mg Injection.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ≤ 2.
• 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.
• Patient should be able to comply with study requirement in the opinion of Investigator.
• Non-smoker defined as non-smoker for at least 6 months (i.e. subject has not smoked or used any tobacco products for the 6 months prior to the screening visit).
• Patients must not have taken any anti-androgens, estrogen, antiestrogen, aromatase inhibitors or hormonal forms of contraception within past one month of screening. Patient may have had recent use of oral contraceptive pills but these must be discontinued 30 days prior to dosing.
• Adequate hematologic status, renal and liver function.
• Women of childbearing potential (WOCBP\*) must not be pregnant or breastfeeding (as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at baseline).

You may not qualify if:

• 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.
• Presence of clinically significant physical exam, laboratory, medical history, ECG findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.
• Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
• Patients receiving anticoagulation medications.
• Patients with uncontrolled diabetes mellitus (HbA1c \> 8 % as per ADA) at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
• Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically confirmed brain metastasis.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Mahatma Gandhi Cancer Hospital & Research Institute

Visakhapatnam, Andhra Pradesh, 530017, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Goserelin acetate 3.6 mg Injection Eurofarma Laboratorios S.A Dose: 3.6 mg, Subcutaneously at every 28 days Reference product -R ZOLADEX® 3.6mg Injection. Dose: 3.6 mg, Subcutaneously at every 28 days

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 3, 2019
• Study Start: October 30, 2020
• Primary Completion: September 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)