Pharmacodynamic Study of Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients With Advanced Breast Cancer

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Goserelin

Criteria

Inclusion Criteria:

1. Pre-menopausal* female patients of 18 to 50 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 50 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]

2. BMI 18.5 to 30 kg/m2 (both inclusive).

3. Patient with a confirmed diagnosis of advanced breast cancer (stage III or stage IV or recurrent metastatic disease)

4. 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.

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

6. Patients with life expectancy of at least 3 months.

7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.

8. Patient should be able to comply with study requirement in the opinion of Investigator.

9. 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).

10. Patients must not have taken any anti-androgens, estrogen, antiestrogen, selective estrogen receptor modulators, 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.

Exclusion Criteria:

1. Patients who are not able to provide written informed consent.

2. Patients who are menopausal

3. Patients who are pregnant or breastfeeding.

4. 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

5. Patients with a clinically significant medical condition other than advanced 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.

6. Presence of clinically significant physical exam, laboratory, medical history, ECG/echocardiogram findings that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.

7. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.

8. Patients receiving anticoagulation medications.

9. Patients with uncontrolled diabetes mellitus at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)

10. Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically-confirmed brain metastasis.

11. Uncontrolled hypertension (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias. (Patients with hypertension controlled by antihypertensive therapies are eligible).

12. Patients with a QTc>450ms on the ECG at screening.

13. History of clinically significant cardiovascular disorder

14. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen which is not consistent with current medical treatment.

15. Concomitant use of medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.

16. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.

17. Patients who test positive for HIV and/or syphilis.

18. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with goserelin metabolism or to cause a drug-drug interaction.

19. Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.

20. Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures.

21. Presence of clinically significant findings on the physical exam, laboratory testing, medical history, ECG that in the opinion of the Investigator may interfere with trial conduct, patient safety, or interpretation of results.

22. Any contraindications for goserelin administration.

23. Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) throughout the trial and for 4 weeks after the last dose of study medication.