Breast CancerPhase 3NCT01073865
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
A Phase 3 study testing ZD9393 (Zoladex) 10.8 mg and ZD9393 (Zoladex) 3.6 mg in people with Breast Cancer, run by AstraZeneca at 55 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 20 to 130 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ZD9393 (Zoladex) 10.8 mg and ZD9393 (Zoladex) 3.6 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 55 sitesin 6 countries
- Study dates
- 26 Feb 2010to 20 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
55 sites in 6 countries.
55 sites in 6 countries
Japan19 sites
Research Site
Amagasaki-shi, 660-8511
Research Site
Chiba, 260-8717
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 811-1395
Research Site
Hamamatsu, 430-0906
Research Site
Hiroshima, 730-8518
Research Site
Kagoshima, 892-0833
Research Site
Kamogawa-shi, 296-0041
Research Site
Kitaadachi, 362-0806
Research Site
Kumamoto, 862-8505
Research Site
Kyoto, 602-8566
Research Site
Mitaka-shi, 181-8611
Research Site
Nagoya, 464-8681
Research Site
Nagoya, 465-0024
Research Site
Niigata, 951-8566
Research Site
Osaka, 540-0006
Research Site
Osaka, 553-0003
Research Site
Sakaishi, 593-8304
Research Site
Sapporo, 003-0804
India15 sites
Research Site
Ahmedabad, 380009
Research Site
Bangalore, 560029
Research Site
Bangalore, 560090
Research Site
Chennai, 600010
Research Site
Hubli, 580025
Research Site
Hyderabad, 500024
Research Site
Jaipur, 302017
Research Site
Mumbai, 400012
Research Site
Nagpur, 440012
Research Site
New Delhi, 110060
Research Site
New Delhi, 110085
Research Site
Pune, 411001
Research Site
Pune, 411004
Research Site
Pune, 411005
Research Site
Thiruvananthapuram, 695011
Philippines6 sites
Research Site
Cebu City, 6000
Research Site
Iloilo City, 5000
Research Site
Lipa City, 4217
Research Site
Pasay
Research Site
Quezon City, 1104
Research Site
Quezon City
Thailand6 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Maharat Nakorn Ratchasima, 30000
Research Site
Songkhla, 90110
Research Site
Ubonratchathani, 34000
Taiwan5 sites
Research Site
Kaohsiung City, 807
Research Site
Taichung, 40705
Research Site
Taichung
Research Site
Taipei, 10002
Research Site
Taipei, 11217
South Korea4 sites
Research Site
Seoul, 05505
Research Site
Seoul, 135-710
Research Site
Seoul, 139-706
Research Site
Suwon, 16499
About this study
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.
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.
- Conditions
- Breast Cancer
- Being tested
- ZD9393 (Zoladex) 10.8 mg, ZD9393 (Zoladex) 3.6 mg
- Keywords
- ZOLADEX, Pre-menopausal, Oestrogen Receptor, Advanced Breast Cancer, Progression Free Survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD9393 (Zoladex) 10.8 mgDrug
Also called Zoladex
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
ZD9393 (Zoladex) 3.6 mgDrug
Also called Zoladex
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Drug: ZD9393 (Zoladex) 10.8 mg |
| 2 | Active comparator | 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. Receives: Drug: ZD9393 (Zoladex) 3.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks after the first dosing
Secondary outcomes (2)
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.
Measured: 24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
E2 serum concentrations (pg/mL) at 24 weeks
Measured: 24 weeks after the first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study start26 Feb 2010
- Primary completion19 Sep 2012
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin Lindemann, PO, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073865
- Sponsor's protocol ID
- D8666C00001
- Status last verified
- Nov 2018
- First submitted
- 22 Feb 2010
- Last updated
- 12 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01073865
- Acronym / sponsor ID
- D8666C00001
- Conditions
- Breast Cancer
- Keywords
- ZOLADEX, Pre-menopausal, Oestrogen Receptor, Advanced Breast Cancer, Progression Free Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2010 (actual)
- Primary completion
- 19 Sep 2012 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ZD9393 (Zoladex) 10.8 mgZoladex 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 |
| 2 | Active comparator | Drug: ZD9393 (Zoladex) 3.6 mgZoladex 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. |
Who may qualify
- Ages
- 20 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD9393 (Zoladex) 10.8 mgAlso: Zoladex10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days). | Drug | 1 |
| ZD9393 (Zoladex) 3.6 mgAlso: Zoladex3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days). | Drug | 2 |
Primary outcome
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
Time frame: 24 weeks after the first dosing
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.
2 secondary outcomes
Number of Responders at 24 Weeks
Time frame: 24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
Time frame: 24 weeks after the first dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D8666C00001ClinicalStudyProtocol\_personal\_info\_redacted\_12December.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Lindemann, PO study director
AstraZeneca
55 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZD9393 (Zoladex) 10.8 mg and ZD9393 (Zoladex) 3.6 mg in people with Breast Cancer, run by AstraZeneca at 55 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Japan, India, Philippines, Thailand, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Progression-free Survival (PFS) at 24 Weeks (time frame: 24 weeks after the first dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.