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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00673335

NCT00673335
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You carry a harmful change (mutation) in the BRCA1 or BRCA2 gene (specifically a nonsense mutation or stop mutation)
  • You have chosen not to have preventive (risk-reducing) mastectomy (breast removal surgery)
  • If you have had breast cancer before, it was only in one breast, it was more than 5 years ago, and there has been no sign of it coming back
  • You have had a mammogram or MRI scan of the breast within the past year that showed no signs of breast cancer
  • You meet one of the following criteria related to menopause: you are over 60 years old; you have had both ovaries removed; you are 60 or under, have not had a hysterectomy, and have not had a period in the last 12 months; or you are 60 or under, have had a hysterectomy, and a specific hormone level (FSH) in your blood is above 20 IU/L
  • You are generally healthy and able to carry out normal daily activities (confirm with trial site)
  • Your blood counts are at healthy levels — including white blood cells, platelets, and haemoglobin (red blood cells)
  • Your liver and kidney function are within acceptable ranges
  • Your heart and cardiovascular system are in good health, with no history of heart attack, angina, or heart failure
  • A recent bone density scan (within the past 2 years) shows you do not have osteoporosis, and you have not had a bone fracture related to osteoporosis

Who may not be able to join:

  • You have been diagnosed with any invasive cancer in the past 5 years (certain common skin cancers and a specific type of cervical pre-cancer are exceptions — confirm with trial site)
  • You have had cancer in both breasts at any point
  • You have already had both breasts removed
  • You have had a stroke in the past
  • You have had a heart attack or been diagnosed with cardiac ischemia (reduced blood supply to the heart)
  • You have a known allergy or sensitivity to letrozole (the study drug) or any of its ingredients, particularly titanium oxide
  • You have significant kidney problems, liver problems, or bile flow problems
  • There are geographical, social, or personal reasons that would make it difficult for you to attend regular medical check-ups as required by this study (confirm with trial site)
  • You are currently under legal guardianship or have restrictions on your personal freedom
  • You have used hormone replacement therapy (e.g., certain thyroid medications) within the past 3 months
  • You have used any hormonal therapy within the past year
  • You are currently taking part in another clinical trial involving an experimental drug

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
UNICANCER
Registry
clinicaltrials_gov
Start date
1 May 2008
Est. completion
1 June 2019

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer); Survival without invasive breast cancer at 5 years

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov