Phase 3
Completed N=222
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
Source: ClinicalTrials.gov NCT01073865 ↗Enrolled (actual)
222
Serious AEs
5.4%
Results posted
Jan 2014
Primary outcomePrimary: Number of Patients With Progression-free Survival (PFS) at 24 Weeks — 67; 68 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Progression-free Survival (PFS) at 24 Weeks |
67; 68 | — |
| SECONDARY Number of Responders at 24 Weeks |
21; 25 | — |
| SECONDARY Oestradiol (E2) Serum Concentrations at 24 Weeks |
20.302; 24.798 | — |
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
Data sourced from ClinicalTrials.gov (NCT01073865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.