Postmenopausal Women With Advanced Breast CancerPhase 2NCT00237198
Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment
A Phase 2 study testing Letrozole in people with Postmenopausal Women With Advanced Breast Cancer, run by Novartis Pharmaceuticals at 24 sites in Japan.
Trial summary
Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment To investigate changes in blood drug concentrations and blood hormone kinetics. Read more about this study
- Who is it for?
- Ages 20 to 79 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
- 47 participants
- Where
- 24 sitesJapan
- Study dates
- Mar 2004to Jul 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 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically documented breast cancer
- Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
- Patients with hormone receptor (ER and/or PgR) positive or both unknown.
- Postmenopausal patients between ages 20 and 79 years, inclusive
- Patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
- Patients with documented measurable or evaluable lesions.
- Patients with sufficient organ function to evaluate the safety
- Patients whose performance status (PS) is 0～2
Who cannot join
- Patients with diffuse lymphangitis carcinomatosa of the lung or CNS involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
- Patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
- Patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
- Patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
- Patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
- Patients with adrenal insufficiency (treated or untreated) or Cushing's syndrome
Show all 15Show fewer
- Patients with any of the following previous treatments
- Chemotherapy for metastatic and/or locoregional recurrent disease
- Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration
- Previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or LH-RH analogues treatment
- Patients who have not recovered from toxicity caused by previous therapy
- For patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic
- Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
- Patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8677
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Cyuo-ku, Tokyo, 104-8560
Novartis Investigative Site
Fukuoka, Fukuoka, 811-1395
Novartis Investigative Site
Fukushima, 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
Koto, Tokyo, 135-8550
Novartis Investigative Site
Kurashiki, Okayama-ken, 701-0192
Novartis Investigative Site
Kure, Hiroshima, 737-0023
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Matsuyama, Ehime, 791-0280
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Novartis Investigative Site
Nagoya, Aichi-ken, 465-0024
Novartis Investigative Site
Niigata, Niigata, 951-8566
Novartis Investigative Site
Osaka, Osaka, 537-8511
Novartis Investigative Site
Sapporo, Hokkaido, 003-0804
Novartis Investigative Site
Sapporo, Hokkaido, 060-0001
Novartis Investigative Site
Sapporo, Hokkaido, 063-0812
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
Novartis Investigative Site
Shizuoka, Shizuoka, 420-0881
Novartis Investigative Site
Sunto-gun, Shizuoka, 411-8777
Novartis Investigative Site
Yokohama, Kanagawa, 241-0815
About this study
- Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment
- To investigate changes in blood drug concentrations and blood hormone kinetics.
- To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole
- 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 (6)
Clinical Benefit Rate during treatment
Measured: Until disease progression or appearance of unacceptable toxicity whichever comes first
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
Time to treatment failure
Measured: from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks
Measured: Baseline, 52 weeks
Plasma estrogens level
Measured: baseline, 52 weeks
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 startMar 2004
- Primary completionJul 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
- 47 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
- NCT00237198
- Sponsor's protocol ID
- CFEM345F1203
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment
- ClinicalTrials.gov ID
- NCT00237198
- Acronym / sponsor ID
- CFEM345F1203
- Keywords
- Aromatase inhibitor, letrozole, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- Mar 2004
- Primary completion
- Jul 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.
- Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment
- To investigate changes in blood drug concentrations and blood hormone kinetics.
- To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole
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 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically or cytologically documented breast cancer
- Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
- Patients with hormone receptor (ER and/or PgR) positive or both unknown.
- Postmenopausal patients between ages 20 and 79 years, inclusive
- Patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
Key exclusion criteria (15 listed)
- Patients with diffuse lymphangitis carcinomatosa of the lung or CNS involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
- Patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
- Patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
- Patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
- Patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
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
6 secondary outcomes
Clinical Benefit Rate during treatment
Time frame: Until disease progression or appearance of unacceptable toxicity whichever comes first
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
Time to treatment failure
Time frame: from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression
Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks
Time frame: Baseline, 52 weeks
Plasma estrogens level
Time frame: baseline, 52 weeks
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 23 Feb 2017.
Related trials for Postmenopausal Women With Advanced Breast Cancer
RecruitingPhase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Metastatic Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Active, not recruitingPhase 3
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
Breast Cancer
Active, not recruitingPhase 2
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
Advanced Breast Cancer
Active, not recruitingPhase 2
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
Breast Neoplasms
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
24 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 24 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 8 inclusion and 15 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 23 Feb 2017.