Postmenopausal Women With Advanced Breast CancerPhase 2NCT00237211
Study of High-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 12 sites in Japan.
Trial summary
To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones. 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
- 31 participants
- Where
- 12 sitesJapan
- Study dates
- Jun 2001to Oct 2006
- 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 with histologically documented breast cancer.
- Patients with hormone receptor (ER and/or PgR) status of positive or unknown
- Patients who have been amenorrheic for the preceding 12 months or more.
- Patients who are 20 years or older and younger than 75 years.
- Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen.
- Patients with progressing lesions.
Show all 9Show fewer
- Patients with sufficient organ function to evaluate the safety
- Patients whose performance status (PS) is classified in 0～2.
- Patients who have no residual effects from previous treatments
Who cannot join
- Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).
- Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease)
- Patients who have previously received aromatase inhibitor.
- Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.
- Other protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8677
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Fukushima, 960-1295
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Kitaadachi-gun, Saitama, 338-8553
Novartis Investigative Site
kooriyama, Fukushima, 963-8501
Novartis Investigative Site
Kurashiki, Okayama-ken, 701-0192
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Matsuyama, Ehime, 791-0280
Novartis Investigative Site
Osaka, 537-8511
Novartis Investigative Site
Saitama, 338-8553
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
About this study
To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.
- 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
Measured: Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Measured: Until disease progression or appearance of unacceptable toxicity whichever comes first
Secondary outcomes (4)
Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
Measured: Maximum 28 weeks after initiate treatment
Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
Measured: Maximum 28 weeks after initiate treatment
Duration of response
Measured: From the first date of response confirmed and the last date of response confirmed
Time to progression
Measured: From the first date of response confirmed and the last date of response confirmed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJun 2001
- Primary completionOct 2006
- Study completionOct 2006
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
- 31 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
- NCT00237211
- Sponsor's protocol ID
- CFEM345F1201
- Status last verified
- Nov 2018
- First submitted
- 9 Oct 2005
- Last updated
- 14 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00237211
- Acronym / sponsor ID
- CFEM345F1201
- Keywords
- Aromatase inhibitor, letrozole, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- Jun 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Oct 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 and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.
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 (9 listed)
- Patients with histologically documented breast cancer.
- Patients with hormone receptor (ER and/or PgR) status of positive or unknown
- Patients who have been amenorrheic for the preceding 12 months or more.
- Patients who are 20 years or older and younger than 75 years.
- Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen.
Key exclusion criteria (5 listed)
- Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).
- Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease)
- Patients who have previously received aromatase inhibitor.
- Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.
- Other protocol-defined inclusion / exclusion criteria may apply.
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
Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
Response Rate during treatment
Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
4 secondary outcomes
Pharmacokinetics measurement at baseline and at every 4 weeks until 28 weeks
Time frame: Maximum 28 weeks after initiate treatment
Plasma estrogens level at baseline and at every 4 weeks until 28 weeks
Time frame: Maximum 28 weeks after initiate treatment
Duration of response
Time frame: From the first date of response confirmed and the last date of response confirmed
Time to progression
Time frame: From the first date of response confirmed and the last date of response confirmed
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 14 Nov 2018.
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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
12 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 12 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 9 inclusion and 5 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 (time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first). The study lists 2 primary outcomes in all. 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 14 Nov 2018.