PRE-SURGICAL TEST OF LETROZOL IN POST MENOPAUSE PATIENTS WITH BREAST CANCER SENSITIVE OPERABLE HORMONE
- Conditions
- -C508 Overlapping lesion of breastOverlapping lesion of breastC508
- Registration Number
- PER-083-09
- Lead Sponsor
- universidad de Vanderbilt,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• Patients must give written informed consent.
• Operating status ECOG 0-1.
• Invasive breast carcinoma, stage I or II (T or T, N or N), which is ^ 1c 2 or 1 RE-positive for IHC and Her2-negative for Herceptest (0 or 1+) or not having an over- FISH expression.
• Measurable Tumor
• Measurable disease: a mass that can be reproducible, measurable by physical examination and / or ultrasound and is at least 1 cm in size.
• Consultations: All patients should be evaluated by a surgeon before study entry.
• Core biopsies available at the time of diagnosis. These may include sections of paraffin fixed material.
• Post-menopausal female subjects> 18 years of age
• No previous chemotherapy for this primary breast cancer.
• Patients with a previous history of contralateral breast cancer are eligible if they have no evidence of recurrence in their initial primary breast cancer.
• Women may have taken tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug at least 21 days prior to Westudio recruitment.
• Subjects must have completed hormone replacement therapy (HRT) (eg, conjugated estrogen tablets, USP, [Premarin]), at least one month (30 days) prior to receiving the first dose of randomized therapy.
• Patients must have adequate liver and kidney function. All tests must be obtained within 4 weeks of entering the study.
• Able to swallow and retain oral medication.
• Patients with locally advanced disease who are candidates for pre-surgical chemotherapy at the time of the initial evaluation.
• Locally recurrent breast cancer.
• Evidence of distant metastatic disease (eg, lung, liver, bone, brain, etc.).
• Serious medical illness that, in the judgment of the attending physician, places the patient at high risk of surgical mortality.
• Severe uncontrolled malabsorption disease or condition (eg diarrhea grade 11/111; severe malnutrition, short bowel syndrome).
• History of another malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of non-melanoma skin cancer, completely resected or in situ carcinomas treated successfully are eligible.
• Dementia, altered mental state, or any psychiatric condition that does not allow the understanding or representation of informed consent.
• Concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, hormone therapy, or any biological therapy).
• Concurrent treatment with an investigative agent.
• Use of a research drug in the 30 days or 5 periods, the one that has more time, preceding the first dose of the study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Performing the OncotypeDX test during the study.<br>Measure:Variation in the recurrence score of the OncotypeDX test<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Performing the OncotypeDX test and RNA profiles during the study.<br>Measure:Variation in the recurrence score of the OncotypeDX test and RNA profiles.<br>Timepoints:During the study<br>