Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Val d'Aurelle - Paul Lamarque
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00949598
First received: July 29, 2009
Last updated: January 21, 2011
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: letrozole Drug: tamoxifen citrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase (Letrozole) vs a SERM (Tamoxifen) for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma [ Designated as safety issue: No ]
- Survival rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 177 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral letrozole once daily for 16 weeks.
|
Drug: letrozole
Given orally
|
|
Experimental: Arm II
Patients receive oral tamoxifen citrate once daily for 16 weeks.
|
Drug: tamoxifen citrate
Given orally
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949598
Locations
| France | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Philippe Rouanet, MD, PhD 04-67-61-3071 prouanet@valdorel.fnclcc.fr | |
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
| Principal Investigator: | Philippe Rouanet, MD, PhD | Centre Val d'Aurelle - Paul Lamarque |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00949598 History of Changes |
| Other Study ID Numbers: | CDR0000638373, CLCC-LETROTAM, VA 2007/09, INCA-RECF0916, EUDRACT-2007-000900-34 |
| Study First Received: | July 29, 2009 |
| Last Updated: | January 21, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
estrogen receptor-positive breast cancer stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Citric Acid Tamoxifen Letrozole Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013