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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT00949598
• Date of registration: 29/07/2009
• Prospective Registration: No
• Primary sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Public title: Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer
• Scientific 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.
• Date of first enrolment: December 2008
• Target sample size: 177
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00949598
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Philippe Rouanet, MD, PhD
• Affiliation: Institut du Cancer de Montpellier - Val d'Aurelle

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: letrozole

Drug: tamoxifen citrate

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

CDR0000638373

Source(s) of Monetary Support

Please refer to primary and secondary sponsors