Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: ZD9393 (Zoladex) 10.8 mg; Drug: ZD9393 (Zoladex) 3.6 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01073865

D8666C00001

Details and patient eligibility

About

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 estrogen receptor positive advanced 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.

Enrollment: 222 patients

Sex: Female

Ages: 20 to 130 years old

Volunteers: No Healthy Volunteers

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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: ZD9393 (Zoladex) 10.8 mg

2

Active Comparator group

Description:

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.

Treatment:

Drug: ZD9393 (Zoladex) 3.6 mg