Clinical trial · Interventional
Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation
Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation
NCT00673335CI-TRIAL-00078443LIBERcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| brca1 Mutation Carrier | — | UNRESOLVED | — |
| brca2 Mutation Carrier | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Breast/Ovarian Cancer (brca1, brca2) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Letrozole, 1 tablet
- interventionNames
- Drug: letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Comparator, 1 tablet
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)
- timeFrame
- 2017
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Must meet the following criteria:
* With or without invasive unilateral breast cancer more than 5 years ago, with no recurrence
* No evidence of breast cancer by mammography or MRI within the past year
* Carrier of the BRCA1/BRCA2 deleterious mutation (nonsense mutation or stop)
* Refused preventive mastectomy
* No prior bilateral breast cancer
* No prior bilateral mastectomy
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Menopausal status as indicated by 1 of the following criteria:
* Age \> 60 years
* Bilateral oophorectomy
* Age ≤ 60 years with no hysterectomy or amenorrhea within the past 12 months
* Age ≤ 60 years with prior hysterectomy or FSH \> 20 IU/L
* Eastern Cooperative Oncology Group (ECOG) or WHO performance status 0-1
* absolute neutrophil count (ANC) \> 2,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 10 g/dL
* Bilirubin normal
* ALT and AST \< 2.5 times upper limit of normal
* Creatinine clearance ≥ 60 mL/min
* Adequate cardiovascular function (e.g., no history of myocardial infarction, angina pectoris, or heart failure)
* No osteoporosis by bone density scan (DEXA) within the past 2 years or prior osteoporotic fracture (femur, lumbar spine T score \> -2 DS)
Exclusion criteria:
* Invasive cancer diagnosed in the past 5 years, except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Prior cerebrovascular accident
* Prior cardiac ischemia
* Hypersensitivity to letrozole or its excipients, especially titanium oxide
* Renal or hepatocellular insufficiency, cholestasis, or cytolysis
* Geographical, social, or psychological reasons that preclude medical monitoring in this study
* Deprived of liberty or guardianship
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 months since prior and no concurrent hormone replacement therapy (e.g., thyroid-stimulating hormone)
* No prior hormonal therapy in the past year
* No concurrent participation in another therapeutic study with an experimental drugReferences
Publications (2)
- BACKGROUNDPujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4. PMID 22076253
- RESULTPujol P, Mijonnet S, Karen S, et al.: Breast cancer prevention by letrozole in post menopausal BRCA1/2 mutations carriers: The Onco-03/LIBER trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-1048, 2009.