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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Completed

CT.gov ID

NCT00949598

Collaborator

(none)

177

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: letrozole Drug: tamoxifen citrate	Phase 3

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

Study Type:

Interventional

Actual Enrollment :

177 participants

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.

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate [up to 24 months]

Secondary Outcome Measures

Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma [up to 24 months]
Survival rate [up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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