Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation
- Conditions
- brca1 Mutation CarrierBreast CancerHereditary Breast/Ovarian Cancer (brca1, brca2)brca2 Mutation Carrier
- Interventions
- Drug: Placebo
- Registration Number
- NCT00673335
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate the reduction of the incidence of invasive breast cancer in postmenopausal women with the BRCA1/BRCA2 mutation treated with letrozole.
Secondary
* Determine the reduction of the incidence of in situ breast cancer in these women.
* Determine the recurrence rate of local or metastatic disease in women who have had breast cancer.
* Determine the incidence of non-breast cancer, especially ovarian, colon, or endometrial cancer.
* Assess the tolerance of this drug in terms of lipid, cardiovascular, and bone effects.
* Determine the quality of life of women treated with this drug.
* Identify serological markers that allow early diagnosis of hereditary predisposition for breast cancer.
* Conduct pharmacogenetic analysis.
* Identify biomarkers or genes involved in the occurrence of cardiovascular and rheumatologic metabolic aromatase inhibitors.
* Study the phenotypic characteristics of cancers that occur during treatment with letrozole, in particular hormonal markers (estrogen and progesterone receptor) and expression profiles of resistance to therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to nature of mutation (BRCA1 vs BRCA2), oophorectomy in premenopausal state (yes vs no), and prior breast cancer (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral letrozole once daily.
* Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 5 years in the absence of unacceptable toxicity or development of cancer or recurrent disease.
Blood samples are collected periodically for pharmacogenetic studies and analysis of biomarkers or genes associated with hereditary predisposition for breast cancer, toxicities, and resistance to therapy.
After completion of study treatment, patients are followed for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Comparator, 1 tablet Treatment arm letrozole Letrozole, 1 tablet
- Primary Outcome Measures
Name Time Method Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer) 2017 Survival without invasive breast cancer at 5 years 2017
- Secondary Outcome Measures
Name Time Method Overall survival at 5 and 10 years 2017 and 2022 Toxicity according to CTCAE version 3.0 2017 and 2022 Lipid tolerance or cardiovascular or bone event 2017 and 2022 Relapse-free (local or metastatic disease) survival in patients with history of breast cancer at 5 and 10 years 2017 and 2022 Second cancer-free survival at 5 and 10 years 2017 and 2022 Event- free (local relapse or metastatic, contralateral, or second cancer) survival at 5 and 10 years 2017 and 2022 Quality of life according to MRS and SF36 questionnaires 2017 and 2022 Invasive cancer-free survival at 10 years 2022 Breast cancer in situ-free survival at 5 and 10 years 2022
Trial Locations
- Locations (23)
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Centre Hospitalier General de Niort
🇫🇷Niort, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Polyclinique De Courlancy
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Oscar Lambret
🇫🇷Lille, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopital Saint Michel
🇫🇷Paris, France
Hotel Dieu de Paris
🇫🇷Paris, France
Institut Curie Hopital
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
CHU Sainte-Etienne - Hopital Nord
🇫🇷Saint-Étienne, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France