Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments zd9393 (zoladex)
Phase phase 3
Sponsor AstraZeneca
Start date February 2010
End date September 2012
Trial size 286 participants
Trial identifier NCT01073865, D8666C00001

Summary

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with advanced or recurrent breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days). One oral tamoxifen 20 mg tablet also will be taken daily
zd9393 (zoladex) Zoladex
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
(Active Comparator)
Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
zd9393 (zoladex) Zoladex
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Primary Outcomes

Measure
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
time frame: 24 weeks after the first dosing

Secondary Outcomes

Measure
Number of Responders at 24 Weeks
time frame: 24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
time frame: 24 weeks after the first dosing

Eligibility Criteria

Female participants from 20 years up to 130 years old.

Inclusion Criteria: - Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation. For patients who have had a hysterectomy, it is acceptable to meet only - Hormone sensitivity (ER positive) of primary or secondary tumour tissue. - Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer. Exclusion Criteria: - Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer - Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation - Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or

Additional Information

Official title An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.