Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation (LIBER)
|ClinicalTrials.gov Identifier: NCT00673335|
Recruitment Status : Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : May 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2)||Drug: letrozole Drug: Placebo||Phase 3|
- Evaluate the reduction of the incidence of invasive breast cancer in postmenopausal women with the BRCA1/BRCA2 mutation treated with letrozole.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||386 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
U.S. FDA Resources
Experimental: Treatment arm
Letrozole, 1 tablet
Other Name: Femara
Placebo Comparator: Placebo
Comparator, 1 tablet
- Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer) [ Time Frame: 2017 ]
- Survival without invasive breast cancer at 5 years [ Time Frame: 2017 ]
- Invasive cancer-free survival at 10 years [ Time Frame: 2022 ]
- Breast cancer in situ-free survival at 5 and 10 years [ Time Frame: 2022 ]
- Relapse-free (local or metastatic disease) survival in patients with history of breast cancer at 5 and 10 years [ Time Frame: 2017 and 2022 ]
- Second cancer-free survival at 5 and 10 years [ Time Frame: 2017 and 2022 ]
- Event- free (local relapse or metastatic, contralateral, or second cancer) survival at 5 and 10 years [ Time Frame: 2017 and 2022 ]
- Overall survival at 5 and 10 years [ Time Frame: 2017 and 2022 ]
- Toxicity according to CTCAE version 3.0 [ Time Frame: 2017 and 2022 ]
- Lipid tolerance or cardiovascular or bone event [ Time Frame: 2017 and 2022 ]
- Quality of life according to MRS and SF36 questionnaires [ Time Frame: 2017 and 2022 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673335
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Hopital Arnaud de Villeneuve|
|Montpellier, France, 34295|
|Centre Catherine de Sienne|
|Nantes, France, 02|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Centre Hospitalier General de Niort|
|Niort, France, 79021|
|Hopital Saint Michel|
|Paris, France, 75015|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Institut Curie Hopital|
|Paris, France, 75248|
|Poitiers, France, 86021|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|CHU Sainte-Etienne - Hopital Nord|
|Sainte-Etienne, France, 42055|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Pascal Pujol, MD||Hopital Arnaud de Villeneuve|