Primary outcomeCount of participants· 24 weeks after the first dosing
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
| Group | Value (Participants) |
|---|---|
| Zoladex 10.8 mg | 67 |
| Zoladex 3.6 mg | 68 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataStudy to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
NCTNCT01073865 (opens ClinicalTrials.gov in a new tab)Other idD8666C00001
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 222 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Open label (no masking)
- Countries
6 countries
India, Japan, Philippines, South Korea, Taiwan, Thailand
- Start
- 26 Feb 2010
- Primary completion
- 19 Sept 2012
- Completion
- 20 Nov 2017
- First posted
- 23 Feb 2010 (estimated)
- Last update posted
- 12 Dec 2018
- Conditions
- Breast Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102012201420162018
- Ph 3
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
NCT0107386526 Feb 2010 to 20 Nov 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ZD9393 (Zoladex) 10.8 mgDrug
- ZD9393 (Zoladex) 3.6 mgDrug
Arms2
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
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
Time frame · 24 weeks after the first dosing
Registry description
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.
Secondary outcomes(2)
Number of Responders at 24 Weeks
Time frame · 24 weeks after the first dosing
Registry description
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.
Oestradiol (E2) Serum Concentrations at 24 Weeks
Time frame · 24 weeks after the first dosing
Registry description
E2 serum concentrations (pg/mL) at 24 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeCount of participants· 24 weeks after the first dosing
Number of Responders at 24 Weeks
| Group | Value (Participants) |
|---|---|
| Zoladex 10.8 mg | 21 |
| Zoladex 3.6 mg | 25 |
Secondary outcomeMean· 24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Zoladex 10.8 mg | 20.302 | 12.251 |
| Zoladex 3.6 mg | 24.798 | 28.149 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Zoladex 10.8 mgZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks | 4 / 108 | 4 / 108 | 47 / 108 |
| Zoladex 3.6 mgZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks | 3 / 113 | 8 / 113 | 52 / 113 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 20 Years up to 130 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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