A study of Goserelin 3.6 mg Injection in patients with Breast cancer.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/02/023101
- Lead Sponsor
- Eurofarma Laboratorios SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
9. Patient should have recovered from any toxic effects of previous
chemotherapy as judged by the Investigator.
10. Patient should be able to comply with study requirement in the opinion of Investigator.
11. 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).
12. 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.
13. Adequate hematologic status, renal and liver function.
14. Women of childbearing potential must not be pregnant or breastfeeding (as documented by a negative serum pregnancy test at screening
and negative urine pregnancy test at baseline).
15. Women of childbearing potential or her partner must use an acceptable and effective non-hormonal method of avoiding pregnancy,
starting at least four weeks before the study drug administration and up to 12 weeks after the after the last dose of study drug administration. Cessation of birth control after this point should be discussed with the responsible physician. For this study, acceptable and effective methods of contraception include:
a) Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1)
b) Barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom)
c) Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom)
d) Absolute sexual abstinence (no sexual intercourse or genital contact with a
male partner). If the patient becomes sexually active during the study, then she is required to use a double barrier method of contraception.
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
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
10. 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 health or the outcome of the trial as judged by the investigator.
11. 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.
12. Patients with a known hypersensitivity to GnRH, GnRH-agonist analogues or any of the components in IMP.
13. Patients receiving anticoagulation medications.
14. Patients with uncontrolled diabetes mellitus (HbA1c > 8 % as per ADA) at randomization (those who have controlled blood sugar (fasting) will be eligible for randomization)
15. Patients with confirmed signs or symptoms related to cerebral metastasis or radiographically confirmed brain metastasis.
16. 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).
17. Patients with a QTc >450ms on the ECG at screening.
18. History of clinically significant cardiovascular disorder
19. 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.
20. 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.
21. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
22. Patients who test positive for HIV and
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation and comparision of the pharmacodynamics of test product against <br/ ><br>reference product and establish non-inferiority.Timepoint: For pharmacodynamics <br/ ><br>Serum Estradiol: <br/ ><br>Day 1, Day 2, Day 8, Day15, Day 22, Day 29, Day-36, <br/ ><br> Day 43, Day 50, Day 57, <br/ ><br>Day 64, Day 7), Day 78 and Day 85 <br/ ><br>Serum LH: <br/ ><br>Day 1, Day 2, Day15, Day 29, Day 43, Day 57, Day 71 and Day 85 <br/ ><br>Serum FSH: <br/ ><br>Day 1, Day 29, Day 57 and Day 85
- Secondary Outcome Measures
Name Time Method Evaluation of the pharmacokinetic and safety of the test product as compared to reference product.Timepoint: For pharmacokinetic <br/ ><br>Pre-dose, Day 1, Day 2, Day 3, Day 6, Day 9, Day 13, Day 14, Day 15, Day 16, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29 <br/ ><br>