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

Phase 3

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Pre-menopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer

• Registration Number: CTRI/2010/091/000255
• Lead Sponsor: AstraZeneca KK Osaka Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Female more or equal 20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2)

E2 more or equal 10 pg/mL and FSH less or equal 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 patients who have relapsed during adjuant chemotherapy or within 24 weeks after completion of adjuant chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified