Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
Status:
Withdrawn
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
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.