Breast Cancer Clinical Trial
Official title:
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients Undergoing Adjuvant Chemotherapy: An Open Label, Randomised, Multi-Centre, Phase IIIb Study
Primary objective of this study is to determine the effectiveness of goserelin acetate
(Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant
chemotherapy for primary invasive breast cancer by documenting persistence or resumption of
regular menses via menstrual history, serum FSH and E2 measurements.
The secondary objectives of this study are as follows: To investigate the impact of
treatment with chemotherapy with or without goserelin acetate (i.e. impact of the
expectation of ovarian function preservation) on participants' quality of life (QOL) by
FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups
by evaluation of adverse events.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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