None listed
Conditions
Interventions
Letrozole will be administered orally at a dose of 2.5 mg / day for 10-21 days to allow variations in surgical programming. Patients should undergo surgical resection in their tumor within 24-72 hours of the last dose of Letrozole.
Sponsors
universidad de Vanderbilt,
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Performing the OncotypeDX test during the study. Measure:Variation in the recurrence score of the OncotypeDX test Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Performing the OncotypeDX test and RNA profiles during the study. Measure:Variation in the recurrence score of the OncotypeDX test and RNA profiles. Timepoints:During the study | — |
Contacts
Public ContactDENISSE BRETEL
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS - INEN
Outcome results
None listed