Status:
COMPLETED
FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Hospital de Clinicas de Porto Alegre
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer;
Detailed Description
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 therap...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Female gender
- Post-menopausal(no age limit) defined as:
- Radiation-induced menopause or surgical bilateral oophorectomy, or
- Women with an intact uterus and
- i. \> 55 years of age or ii. without menses for the last 5 years or iii. £ 55 years of age and has not had menses for at least the last 12 months (but has had menses in the last 5 years) and has postmenopausal levels of FSH c. Women without an intact uterus and i. \> 55 years of age or ii. £ 55 years of age and has postmenopausal levels of FSH
- Contraindications for the use of neoadjuvant/adjuvant chemotherapy, refusal by the patient to receive chemotherapy or if the investigator believes the patient is a suitable candidate for this protocol.
- WHO performance status \< 1
- Histologically-confirmed ductal or lobular operable adenocarcinoma of the breast (stage I, II and III)
- Confirmed absence of liver, lung and bone metastases.
- Primary tumor of at least 2 cm, measured clinically and/or radiologically
- Multifocal invasive tumors are not eligible, unless a biopsy showing ER positivity can be obtained from each tumor lesion.
- ER-positive and/or PgR-positive tumors, defined according to immunohistochemistry (i.e. \> 10% of positive cells after immunostaining), if woman younger 70 years; ER-positive or PgR-positive tumors if woman older than 70 years.
- Fixed and frozen samples from the primary tumor, obtained before treatment, must be available for evaluation of biological markers (cDNA microarrays, EGFR, HER-2, intra-tumoral aromatase).
- No concurrent second malignancy, including contralateral breast cancer (exceptions are: adequately treated basal cell carcinoma of the skin and in situ carcinoma of the cervix). Any prior second malignancy must be in remission for ³ 5 years.
- No other serious illness or medical condition including:
- History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (\< 6 months) transmural infarction on ECG; poorly controlled hypertension (e.g. systolic \>180 mm Hg or diastolic greater than 100 mm Hg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias.
- Chronic lung disease
- History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia.
- Active concurrent infection
- No concurrent or previous anti-cancer treatment is allowed
- Adequate organ function as defined by:
- Neutrophils ³ 1.5 x 109/L
- Platelets ³ 100 x 109/L
- Bilirubin £ 1.5x upper limit of normal (ULN)
- Transaminases £ 2.5x ULN
- Creatinine £ 1.5x ULN
- Normal left ventricular ejection fraction by echocardiography or MUGA scan \[for combination studies only\]
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Before patient registration/randomization, informed consent must be given according to ICH/EU GCP, and national/local regulations.
- Exclusion crieria :
- Non specified
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00199134
Start Date
November 1 2004
End Date
December 1 2014
Last Update
January 6 2015
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000