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

NCT00949598 | Completed Phase 3 DMC

• 1 other identifier: CDR0000638373
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate

  up to 24 months

Secondary Outcomes (2)

• Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma

  up to 24 months

• Survival rate

  up to 24 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral letrozole once daily for 16 weeks.

Drug: letrozole

Arm II

EXPERIMENTAL

Patients receive oral tamoxifen citrate once daily for 16 weeks.

Drug: tamoxifen citrate

Interventions

letrozole DRUG

Given orally

Arm I

tamoxifen citrate DRUG

Given orally

Arm II

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Philippe Rouanet, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (1)