Breast CancerPhase 3NCT00949598
Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
A Phase 3 study testing letrozole and tamoxifen citrate in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Read more about this study
- Who is it for?
- Ages 65 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- letrozole and tamoxifen citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Oct 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 65 to 120 years
- Women only
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast adenocarcinoma
- Clinically T2 tumor and/or > 1 cm by echography
- Estrogen receptor (ER)-positive and > 10% of the tumor cells positive
- No ER-negative disease
- No prior breast cancer
- No metastatic or inflammatory breast adenocarcinoma
PATIENT CHARACTERISTICS:
- Postmenopausal
- No cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
- No prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
- No mental incapacitation that would preclude consent
- No contraindication to tamoxifen citrate or letrozole
PRIOR CONCURRENT THERAPY:
- More than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
- No concurrent therapy that would modify the expression of the genes regulated by estrogen
- No concurrent participation in another clinical study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs tamoxifen citrate.
Secondary
- Compare the response after 4 months of therapy.
- Define the resistant forms of cancer in patients treated with these regimens.
- Define the molecular signature predictive of sensitivity or resistance to ER+ breast adenocarcinoma by gene and serum protein profiling.
- Search for serum protein profiles predictive of recurrence-free interval.
OUTLINE: Patients are randomized into 1 of 2 intervention arms.
- Arm I: Patients receive oral letrozole once daily for 16 weeks.
- Arm II: Patients receive oral tamoxifen citrate once daily for 16 weeks. Patients in both arms then undergo surgery.
Blood and tumor tissue samples are collected at baseline and after completion of neoadjuvant therapy for changes in Ki67 and PCNA and serum protein profiling analysis.
After completion of study therapy, patients are followed up every 6 months for 3 years, and then once a year for 5 years.
- Conditions
- Breast Cancer
- Being tested
- letrozole, tamoxifen citrate
- Keywords
- estrogen receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA 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
Given orally
tamoxifen citrateDrug
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral letrozole once daily for 16 weeks. Receives: Drug: letrozole |
| Arm II | Experimental | Patients receive oral tamoxifen citrate once daily for 16 weeks. Receives: Drug: tamoxifen citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
Measured: up to 24 months
Secondary outcomes (2)
Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma
Measured: up to 24 months
Survival rate
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2010
- Study completionOct 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 Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Rouanet, MD, PhD, Principal investigator, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949598
- Sponsor's protocol ID
- CDR0000638373
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2009
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.
- ClinicalTrials.gov ID
- NCT00949598
- Acronym / sponsor ID
- CDR0000638373
- Conditions
- Breast Cancer
- Keywords
- estrogen receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jul 2009 (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.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.
Detailed description
OBJECTIVES:
Primary
- Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs tamoxifen citrate.
Secondary
- Compare the response after 4 months of therapy.
- Define the resistant forms of cancer in patients treated with these regimens.
- Define the molecular signature predictive of sensitivity or resistance to ER+ breast adenocarcinoma by gene and serum protein profiling.
- Search for serum protein profiles predictive of recurrence-free interval.
OUTLINE: Patients are randomized into 1 of 2 intervention arms.
- Arm I: Patients receive oral letrozole once daily for 16 weeks.
- Arm II: Patients receive oral tamoxifen citrate once daily for 16 weeks. Patients in both arms then undergo surgery.
Blood and tumor tissue samples are collected at baseline and after completion of neoadjuvant therapy for changes in Ki67 and PCNA and serum protein profiling analysis.
After completion of study therapy, patients are followed up every 6 months for 3 years, and then once a year for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: letrozolePatients receive oral letrozole once daily for 16 weeks. |
| Arm II | Experimental | Drug: tamoxifen citratePatients receive oral tamoxifen citrate once daily for 16 weeks. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| letrozoleGiven orally | Drug | Arm I |
| tamoxifen citrateGiven orally | Drug | Arm II |
Primary outcome
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
Time frame: up to 24 months
2 secondary outcomes
Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma
Time frame: up to 24 months
Survival rate
Time frame: up to 24 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 13 Feb 2025.
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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.
Philippe Rouanet, MD, PhD principal investigator
Institut du Cancer de Montpellier - Val d'Aurelle
1 site 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 and tamoxifen citrate in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Feb 2025. 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 France. 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?
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate (time frame: up to 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 13 Feb 2025.