FRAGRANCE Trial(Femara Reanalysed Through Genomics for Response Assessment, Calibration and Empowerment)
The aromatase inhibitors are drugs already approved for the treatment of breast cancer in
the adjuvant and metastatic setting, and have demonstrated a superiority when compared to
other hormone therapy agents as tamoxifen. FRAGRANCE is a trial of neoadjuvant hormone
therapy activated in September 2004 at the Jules Bordet Institute. The main objective of
this study is to find a genetic signature of de novo resistance to letrozole The standard
dose of letrozol, 2,5 mg/day, is given orally during 4 months previous to the definitive
breast surgery. The advantages of the neoadjuvant setting are a) the possibility to directly
evaluate the response to therapy, which is of great value to decide adjuvant treatment; b)
the increase chance of performing breast conserving surgery; c) and, because a tumor sample
is obtained before and after treatment, the identification of predictive markers of response
or resistance to treatment, including a genetic signature, obtained using the microarray
technology. Eligible patients are women with early hormonal receptor positive breast cancer,
with any contra-indication or refusal to the administration of chemotherapy The side effects
of letrozole are already well known, and include more commonly hot flashes, nausea and
vomiting, headache, arthralgia/myalgia, fatigue, and oedema. After surgery, adjuvant
treatment will be done according to the standard practice of the Institute, considering the
possibility of continuing letrozole for a total of at least 5 years, if a satisfactory
response is achieved The first part of this trial will include 49 patients.
This trial will soon become a multicenter, multinational trial of 160 patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate Pathologic complete response rate
at the end of the study
No
Christos Sotiriou, MD, PhD
Study Chair
Jules Bordet Institute
Belgium: Ministry of Social Affairs, Public Health and the Environment
FRAGRANCE
NCT00199134
November 2004
December 2013
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