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A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
Full description
A phase III, two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with breast cancer
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
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Central trial contact
Luiza Terranova; Gleyce Lima
Data sourced from clinicaltrials.gov
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