Clinical trial NCT01073865: Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: ZOLADEX
Pre-menopausal
Oestrogen Receptor
Advanced Breast Cancer
Progression Free Survival
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 222
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.
* 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

Primary outcomes:
measure: Number of Patients With Progression-free Survival (PFS) at 24 Weeks
timeFrame: 24 weeks after the first dosing
Secondary outcomes:
measure: Number of Responders at 24 Weeks
timeFrame: 24 weeks after the first dosing
measure: Oestradiol (E2) Serum Concentrations at 24 Weeks
timeFrame: 24 weeks after the first dosing
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Hubli
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Nagpur
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Thiruvananthapuram
country: India
facility: Research Site
city: Amagasaki-shi
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hamamatsu
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kamogawa-shi
country: Japan
facility: Research Site
city: Kitaadachi
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Kyoto-shi
country: Japan
facility: Research Site
city: Mitaka-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sakai-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City
country: Philippines
facility: Research Site
city: Pasay City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Maharat Nakorn Ratchasima
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
city: Ubonratchathani
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Justin Lindemann, PO
role: STUDY_DIRECTOR
References: