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

Condition(s) targeted: Breast Cancer

Intervention: ZD9393 (Zoladex) (Drug); ZD9393 (Zoladex) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Justin Lindemann, PO, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy: The primary outcome variable is Progression Free Survival (PFS) at 24 weeks. A PF patient is defined as a patient for whom neither objective disease progression nor death (due to any cause) has been observed

Secondary outcome: Overall Response Rate (ORR) at 24 weeks: with response defined as either a complete or partial response based on the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Ver. 1.1)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, Kolkatta, India; Not yet recruiting

Research Site, Mumbai, India; Not yet recruiting

Research Site, Niigata, Japan; Recruiting

Research Site, Osaka, Japan; Recruiting

Research Site, Seoul, Korea, Republic of; Recruiting

Research Site, Pasay City, Philippines; Not yet recruiting

Research Site, Quezon City, Philippines; Recruiting

Research Site, Kaohsiung, Taiwan; Not yet recruiting

Research Site, Bangkok, Thailand; Not yet recruiting

Research Site, Chaing Mai, Thailand; Not yet recruiting

Research Site, Songkla, Thailand; Not yet recruiting

Research Site, Nagoya, Aichi, Japan; Recruiting

Research Site, Hyderabad, Andhrapradesh, India; Not yet recruiting

Research Site, New Delhi, Delhi, India; Not yet recruiting

Research Site, Ahmedabad, Gujarat, India; Recruiting

Research Site, Matsubaracho, Kagoshima, Japan; Recruiting

Research Site, Bangalore, Karnataka, India; Not yet recruiting

Research Site, Nagpur, Maharashtra, India; Not yet recruiting

Research Site, Pune, Maharashtra, India; Not yet recruiting

Research Site, Sakai, Osaka, Japan; Recruiting

Research Site, Jaipur, Rajasthan, India; Not yet recruiting

Research Site, Mitaka, Tokyo, Japan; Recruiting

Starting date: February 2010
Last updated: May 13, 2010