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Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949598
First Posted: July 30, 2009
Last Update Posted: August 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate [ Time Frame: up to 24 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 177
Study Start Date: December 2008
Study Completion Date: October 2010
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

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949598


Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Principal Investigator: Philippe Rouanet, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT00949598     History of Changes
Other Study ID Numbers: CDR0000638373
First Submitted: July 29, 2009
First Posted: July 30, 2009
Last Update Posted: August 5, 2015
Last Verified: August 2015

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
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
Letrozole
Tamoxifen
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents