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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073865
• Other study ID #: D8666C00001
• Status: Completed
• Phase: Phase 3
• Start date: February 26, 2010
• Est. completion date: November 20, 2017

Study information

• Verified date: November 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 20, 2017
• Est. primary completion date: September 19, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ZD9393 (Zoladex) 10.8 mg
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
• ZD9393 (Zoladex) 3.6 mg
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Locations

Country	Name	City	State
India	Research Site	Ahmedabad
India	Research Site	Bangalore
India	Research Site	Bangalore
India	Research Site	Chennai
India	Research Site	Hubli
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Mumbai
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Pune
India	Research Site	Pune
India	Research Site	Pune
India	Research Site	Thiruvananthapuram
Japan	Research Site	Amagasaki-shi
Japan	Research Site	Chiba
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hamamatsu
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kamogawa-shi
Japan	Research Site	Kitaadachi
Japan	Research Site	Kumamoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Mitaka-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Osaka
Japan	Research Site	Osaka-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Sapporo-shi
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Philippines	Research Site	Cebu City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City
Philippines	Research Site	Pasay City
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Maharat Nakorn Ratchasima
Thailand	Research Site	Songkla
Thailand	Research Site	Ubonratchathani

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

India,  Japan,  Korea, Republic of,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Progression-free Survival (PFS) at 24 Weeks	A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.	24 weeks after the first dosing
Secondary	Number of Responders at 24 Weeks	Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.	24 weeks after the first dosing
Secondary	Oestradiol (E2) Serum Concentrations at 24 Weeks	E2 serum concentrations (pg/mL) at 24 weeks	24 weeks after the first dosing

External Links

•   D8666C00001ClinicalStudyProtocol_personal_info_redacted_12December.pdf