Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

Phase 3

Withdrawn

• Conditions: Breast Cancer; Ovarian Function
• Interventions: Drug: Goserelin acetate

• Registration Number: NCT00888082
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• Pathologically confirmed invasive breast carcinoma
• Candidates for adjuvant chemotherapy for primary breast cancer
• Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels

Exclusion Criteria

• Previous systemic chemotherapy
• Pregnancy
• Stage IV breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Goserelin acetate	Patient receiving goserelin acetate along with adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)	Each 3 months
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles	Each 3 months

Secondary Outcome Measures

Name	Time	Method
Quality of life (QOL) through-out the study measured by FACT-ES scale.	Each 3 months

Trial Locations

Locations (1)

Research Site; 🇹🇷 Kayseri, Turkey