Advanced Breast CancerPhase 1NCT00328120
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients
A Phase 1 study testing Fulvestrant in people with Advanced Breast Cancer, run by AstraZeneca at 5 sites in Japan.
Trial summary
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 5 sitesJapan
- Study dates
- Apr 2004to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Postmenopausal woman who fulfils any one of the following criteria:
- Histological or cytological confirmation of breast cancer
- Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).
Who cannot join
- Having received any one of the following therapy for advanced or recurrent breast cancer
- 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Research Site
Chiba
Research Site
Fukuoka
Research Site
Nagoyata
Research Site
Osaka
Research Site
Tokyo
About this study
Official title: An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
- Conditions
- Advanced Breast Cancer
- Being tested
- Fulvestrant
- Keywords
- Advanced breast cancer, Faslodex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Also called Faslodex, ZD9238
500 mg intramuscular injection
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the tolerability of 500mg fulvestrant
Measured: assessed when all patients have been in the study for 6 months
Secondary outcomes (6)
Pharmacokinetics
Measured: each visit
Time to progression
Measured: assessed when all patients have been in the study for 6 months
ORR
Measured: assessed when all patients have been in the study for 6 months
Clinical benefit rate
Measured: assessed when all patients have been in the study for 6 months
Time to response
Measured: assessed when all patients have been in the study for 6 months
duration of response and changes in serum tumour markers
Measured: assessed when all patients have been in the study for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startApr 2004
- Primary completionApr 2006
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Breast Cancer Established Brands Team Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328120
- Sponsor's protocol ID
- D6995C00004
- Other IDs
- 9238IL/0062
- Status last verified
- Nov 2010
- First submitted
- 18 May 2006
- Last updated
- 17 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT00328120
- Acronym / sponsor ID
- D6995C00004
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced breast cancer, Faslodex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent
- Postmenopausal woman who fulfils any one of the following criteria:
- Histological or cytological confirmation of breast cancer
- Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).
Key exclusion criteria (2 listed)
- Having received any one of the following therapy for advanced or recurrent breast cancer
- 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
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 |
|---|---|---|
| FulvestrantAlso: Faslodex, ZD9238500 mg intramuscular injection | Drug | – |
Primary outcome
The primary objective of this study is to assess the tolerability of 500mg fulvestrant
Time frame: assessed when all patients have been in the study for 6 months
6 secondary outcomes
Pharmacokinetics
Time frame: each visit
Time to progression
Time frame: assessed when all patients have been in the study for 6 months
ORR
Time frame: assessed when all patients have been in the study for 6 months
Clinical benefit rate
Time frame: assessed when all patients have been in the study for 6 months
Time to response
Time frame: assessed when all patients have been in the study for 6 months
duration of response and changes in serum tumour markers
Time frame: assessed when all patients have been in the study for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2010.
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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.
Breast Cancer Established Brands Team Medical Science Director, MD study director
AstraZeneca
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fulvestrant in people with Advanced Breast Cancer, run by AstraZeneca at 5 sites in Japan.
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 4 inclusion and 2 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 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to assess the tolerability of 500mg fulvestrant (time frame: assessed when all patients have been in the study for 6 months). 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 17 Nov 2010.