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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT00949598
First received: July 29, 2009
Last updated: August 3, 2015
Last verified: August 2015
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT00949598     History of Changes
Other Study ID Numbers: CDR0000638373
Study First Received: July 29, 2009
Last Updated: August 3, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015