Postmenopausal Women With Advanced Breast CancerPhase 2NCT00247663
Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
A Phase 2 study testing Letrozole in people with Postmenopausal Women With Advanced Breast Cancer, run by Novartis Pharmaceuticals at 10 sites in Japan.
Trial summary
To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Postmenopausal Women With Advanced Breast Cancer
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesJapan
- Study dates
- Dec 1999to Dec 2005
- Phase
- Phase 2
- 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 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients which participated in double blind study
Who cannot join
- Patients with intolerable toxicity.
- Patients which confirmed progressive disease during double blind study.
- Patients which have received concurrent anti-cancer therapy during double blind study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Novartis Investigative Site
Amagasaki, Hyōgo, 660-8511
Novartis Investigative Site
Chuo-Ku, Tokyo, 104-0045
Novartis Investigative Site
Cyuo-ku, Tokyo, 104-8560
Novartis Investigative Site
Fukuoka, 811-4395
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8558
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Kumamoto, 862-0909
Novartis Investigative Site
Nigata-honmachi, 951-8566
Novartis Investigative Site
Saitama, 338-8553
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
About this study
- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.
- Being tested
- Letrozole
- Keywords
- Aromatase inhibitor, letrozole, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called FEM345
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Not described Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety during treatment
Secondary outcomes (1)
No secondary outcomes/objectives planned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startDec 1999
- Primary completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247663
- Sponsor's protocol ID
- CFEM345 1601
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 2005
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00247663
- Acronym / sponsor ID
- CFEM345 1601
- Keywords
- Aromatase inhibitor, letrozole, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- Dec 1999
- Primary completion
- Dec 2005 (actual)
- First posted
- 2 Nov 2005 (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.
- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients which participated in double blind study
Key exclusion criteria (3 listed)
- Patients with intolerable toxicity.
- Patients which confirmed progressive disease during double blind study.
- Patients which have received concurrent anti-cancer therapy during double blind study.
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 |
|---|---|---|
| LetrozoleAlso: FEM345 | Drug | Letrozole |
Primary outcome
Safety during treatment
1 secondary outcome
No secondary outcomes/objectives planned
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 19 Apr 2012.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Postmenopausal Women With Advanced Breast Cancer, run by Novartis Pharmaceuticals at 10 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 1 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety during treatment. 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 19 Apr 2012.