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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01073865
First received: February 22, 2010
Last updated: December 21, 2012
Last verified: December 2012
History of Changes

February 22, 2010
December 21, 2012
February 2010
September 2012   (final data collection date for primary outcome measure)
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 [ Time Frame: At baseline, at week 12 and at week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01073865 on ClinicalTrials.gov Archive Site
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) [ Time Frame: At baseline, at week 12 and at week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: ZD9393 (Zoladex)
    10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
    Other Name: Zoladex
  • Drug: ZD9393 (Zoladex)
    3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
    Other Name: Zoladex
  • Experimental: 1

    Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).

    One oral tamoxifen 20 mg tablet also will be taken daily

    Intervention: Drug: ZD9393 (Zoladex)
  • Active Comparator: 2
    Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
    Intervention: Drug: ZD9393 (Zoladex)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
222
July 2014
September 2012   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   Japan,   Korea, Republic of,   Philippines,   Taiwan,   Thailand
 
NCT01073865
D8666C00001
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Justin Lindemann, PO AstraZeneca
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP