Breast CancerPhase 3NCT00332852
Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
A Phase 3 study testing Letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 53 sites in Germany.
Trial summary
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer. This trial is not recruiting patients in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 53 sitesGermany
- Study dates
- Mar 2006to Jul 2010
- Phase
- Phase 3
- 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
- Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
- Nodal status negative or positive
- Good Health status 0-2 (Eastern Cooperative Oncology Group)
- Estrogen- and/or progesterone-receptor positive
- Adequate marrow, kidney and liver function
Who cannot join
- Metastatic or inflammatory breast cancer
- Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
- Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery
- Patients with primary overactive parathyroid
- Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
Germany53 sites
Novartis Investigative Site
Albstadt
Schorndorf
Augsburg
Novartis Investigative Site
Bamberg
Novartis Investigative Site
Berlin
Novartis Investigative Site
Bonn
Novartis Investigative Site
Bottrop
Novartis Investigative Site
Braunschweig
Novartis Investigative site
Celle
Novartis Investigative Site
Chemnitz
Novartis Investigative Site
Dortmund
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Fulda
Novartis Investigative Site
Gera
Novartis Investigative Site
Gütersloh
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Hamelin
Novartis Investigative Site
Hanover
Novartis Investigative Site
Herne
Novartis Investigative Site
Holzminden
Novartis Investigative Site
Höxter
Novartis Investigative Site
Ilsede
Novartis Investigative Site
Itzehoe
Novartis Investigative Site
Jena
Novartis Investigative Site
Karlsruhe
Novartis Investigative Site
Kempten
Novartis Investigative Site
Konigs
Schorndorf
Konstanz
Novartis Investigative Site
Lich
Novartis Investigative Site
Lohsa/Weisskollm
Novartis Investigative Site
Ludwigsburg
Novartis Investigative Site
Memmingen
Novartis Investigative Site
Mühlhausen
Novartis Investigative Site
München
Novartis Investigative Site
Münster
Novartis Investigative Site
Neumünster
Novartis Investigative Site
Neunkirchen
Novartis Investigative Site
Offenburg
Novartis Investigative Site
Pforzheim
Novartis Investigative Site
Rendsburg
Novartis Investigative Site
Saarbrücken
Novartis Investigative Site
Saarlouis
Novartis Investigative Site
Saint Wendel
Novartis Investigative Site
Salzgitter
Novartis Investigative Site
Schorndorf
Novartis Investigative Site
Schwetzingen
Novartis Investigative Site
Starnberg
Novartis Investigative Site
Stuttgart
Novartis Investigative Site
Tuttlingen
Novartis Investigative Site
Ulm
Novartis Investigative Site
Walsrode
Novartis Investigative Site
Westerburg
Novartis Investigative Site
Wiesbaden
Novartis Investigative Site
Wolfsburg
About this study
Official title: An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.
This trial is not recruiting patients in the United States.
- Conditions
- Breast Cancer
- Being tested
- Letrozole
- Keywords
- Postive breast cancer, postmenopausal, disease free survival, letrozole, early adjuvant treatment, primary hormone receptor
- 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 Femara, FEM345
2.5 mg/day - oraly
| 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.
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
Measured: after 24 months
Secondary outcomes (3)
Disease free survival (DFS)
Measured: every 6 months for 24 months
Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months
Measured: Every 6 months
Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332852
- Sponsor's protocol ID
- CFEM345DDE10
- Status last verified
- Feb 2017
- First submitted
- 31 May 2006
- 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
- An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT00332852
- Acronym / sponsor ID
- CFEM345DDE10
- Conditions
- Breast Cancer
- Keywords
- Postive breast cancer, postmenopausal, disease free survival, letrozole, early adjuvant treatment, primary hormone receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2010 (actual)
- First posted
- 2 Jun 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.
This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.
This trial is not recruiting patients in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: Letrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
- Nodal status negative or positive
- Good Health status 0-2 (Eastern Cooperative Oncology Group)
- Estrogen- and/or progesterone-receptor positive
- Adequate marrow, kidney and liver function
Key exclusion criteria (6 listed)
- Metastatic or inflammatory breast cancer
- Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
- Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery
- Patients with primary overactive parathyroid
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: Femara, FEM3452.5 mg/day - oraly | Drug | Letrozole |
Primary outcome
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
Time frame: after 24 months
3 secondary outcomes
Disease free survival (DFS)
Time frame: every 6 months for 24 months
Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months
Time frame: Every 6 months
Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation
Time frame: every 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 23 Feb 2017.
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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 Pharmeceuticals
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole in people with Breast Cancer, run by Novartis Pharmaceuticals at 53 sites in Germany.
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 5 inclusion and 6 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 53 sites in Germany. 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?
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?
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging (time frame: after 24 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 23 Feb 2017.