Metastatic Breast CancerPhase 4eLEcTRANCT00171847
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer
A Phase 4 study testing Letrozole and Trastuzumab plus Letrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Letrozole and Trastuzumab plus Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Oct 2008
- Phase
- Phase 4
- 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
- Postmenopausal
- Her-2 overexpression and ER and/or PgR positive
- Metastatic Breast Cancer
Who cannot join
- Previous treatment with trastuzumab
- Significant Liver or renal impairment
- Erbb2 negative and/or ER and PgR negative
- Other protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
- Conditions
- Metastatic Breast Cancer
- Being tested
- Letrozole, Trastuzumab plus Letrozole
- Keywords
- Breast cancer, Metastatic, Trastuzumab, Letrozole
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A - HER-2 +ve patients with Femara alone | Experimental | Not described Receives: Drug: Letrozole |
| B - HER-2 +ve patients with Femara + Herceptin | Experimental | Not described Receives: Drug: Trastuzumab plus Letrozole |
| C - HER-2 -ve patients with Femara alone | Experimental | Not described Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
Measured: 3 months
Secondary outcomes (4)
Objective response rate/Clinical Benefit rate
Measured: 3 months
Time to treatment failure
Measured: 3 months
Duration of response/clinical benefit during treatment
Measured: 3 months
Overall survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche - Prof. Dr. Jens Huober et al.
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171847
- Sponsor's protocol ID
- CFEM345C2403
- Acronym
- eLEcTRA
- Status last verified
- Mar 2010
- First submitted
- 13 Sep 2005
- Last updated
- 31 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT00171847
- Acronym / sponsor ID
- eLEcTRA / CFEM345C2403
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, Metastatic, Trastuzumab, Letrozole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Roche - Prof. Dr. Jens Huober et al.
- Study start
- Mar 2003
- Primary completion
- Oct 2008 (actual)
- First posted
- 15 Sep 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.
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - HER-2 +ve patients with Femara alone | Experimental | Drug: Letrozole |
| B - HER-2 +ve patients with Femara + Herceptin | Experimental | Drug: Trastuzumab plus Letrozole |
| C - HER-2 -ve patients with Femara alone | 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 (3 listed)
- Postmenopausal
- Her-2 overexpression and ER and/or PgR positive
- Metastatic Breast Cancer
Key exclusion criteria (4 listed)
- Previous treatment with trastuzumab
- Significant Liver or renal impairment
- Erbb2 negative and/or ER and PgR negative
- 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 |
|---|---|---|
| Letrozole | Drug | A - HER-2 +ve patients with Femara alone |
| Trastuzumab plus Letrozole | Drug | B - HER-2 +ve patients with Femara + Herceptin |
| Letrozole | Drug | C - HER-2 -ve patients with Femara alone |
Primary outcome
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
Time frame: 3 months
4 secondary outcomes
Objective response rate/Clinical Benefit rate
Time frame: 3 months
Time to treatment failure
Time frame: 3 months
Duration of response/clinical benefit during treatment
Time frame: 3 months
Overall survival
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole and Trastuzumab plus Letrozole in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months (time frame: 3 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 31 Mar 2010.