PRE-SURGICAL TEST OF LETROZOL IN POST MENOPAUSE PATIENTS WITH BREAST CANCER SENSITIVE OPERABLE HORMONE

universidad de Vanderbilt,0 个研究点目标入组 0 人开始时间: 2010年4月9日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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.

发起方

universidad de Vanderbilt,