Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Goserelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00303524

Zoladex EBC Study

D8664C00004

Details and patient eligibility

About

The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Enrollment: 170 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.

Exclusion criteria

• Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

1

Experimental group

Description:

Zoladex 3-month depot

Treatment:

Drug: Goserelin acetate

Drug: Goserelin acetate

2

Experimental group

Description:

Zoladex 1-month depot

Treatment:

Drug: Goserelin acetate

Drug: Goserelin acetate