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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    68
  • sponsor
    Eurofarma Laboratorios S.A.
Updated on 25 March 2022
estrogen
advanced breast cancer
estradiol
adjuvant chemotherapy
mammogram

Summary

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

Description

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

Details
Condition Breast Cancer
Treatment Goserelin acetate 3.6 mg Injection, ZOLADEX® 3.6mg Injection
Clinical Study IdentifierNCT03936933
SponsorEurofarma Laboratorios S.A.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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 ≤ 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)

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
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
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)
Patients with a QTc>450ms on the ECG at screening
History of clinically significant cardiovascular disorder
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
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
A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies
Patients who test positive for HIV and/or syphilis
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
Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 180 days prior to receiving the first dose of study medicine
Patients with a mental incapacity, unwillingness, or language barrier that precludes the ability to understand or cooperate with study procedures
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
Any contraindications for goserelin administration
Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) 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
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