PER-059-01未知未知
PHASE III STUDY OF GEMCITABIN WITH PACLITAXEL VERSUS PACLITAXEL IN PATIENTS WITH NON-RESECTIOUS, METASTASIC OR LOCALLY ADVANCED BREAST CANCER
适应症
试验速览
- 阶段
- 未知
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients will have histological or cytological diagnosis that evidences unresectable, locally advanced or metastatic disease. Injuries should not be subject to surgery or radiation with healing intentions.
- •Women at least 18 years of age.
- •Patients who have relapsed after [a] receiving adjuvant / neoadjuvant chemotherapy with anthracycline, unless [b] is clinically contraindicated.
- •Treatment with humanized anit-HER2 antibody is allowed.
- •Clinically measurable disease defined as two-dimensionally measurable lesions with clear margins defined by imaging studies or physical examination. Ultrasound is not an acceptable method to document tumor measurements for this study. An indicator of injury that serves as measurable disease should be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or x-ray, or at least less 2 cm by 2 cm defined by a physical examination.
- •Measurable disease that is outside a previously irradiated area.
- •Radiation must end at least 2 weeks prior to enrollment. Patients must have recovered from the toxic effects of previous therapy.
- •Activity status from 79 to more on the Karnofsky Scale
- •Estimated Life Expectancy for at least 12 weeks
- •Adequate reserve of bone marrow: Absolute granulocyte count (AGC)> 1.5 x 10 6 / L, platelets> 100 x 10 6 / L, and hemoglobin> 9.0 g / dL.
- •Adequate liver function (bilirubin <1.5 times the normal limit [ULN], alanine transaminase (ALT) and aspartate transaminase ASI <2 times ULN (Venook et al., 1998).
- •Calcium <1.2 times ULN.
- •Adequate renal function (creatinine <1.5 times ULN).
- •Antitumor hormone treatment terminated prior to enrollment (until the day of randomization).
- •Bisphophonated therapy is allowed, however, therapy can not stop or start within 4 weeks prior to enrollment.
- •Patient compliance and geographic proximity that allows adequate follow-up.
- •Informed Consent signed by the patient.
- •Women with reproductive potential should use an approved contraceptive method (eg, intrauterine device [IUD], birth control pills or barrier device) during and for 3 months after the study.
排除标准
- •Previous therapy with gemcitabine or a taxane.
- •Previous chemotherapy for metastatic cancer to the breast.
- •Inflammatory breast cancer without evidence of metastatic disease.
- •Active heart disease not controlled by therapy and / or myocardial infarction within the preceding 6 months.
- •Knowledge or suspicion of metastasis / recurrence to the brain that requires treatment with steroids or radiation.
- •Active infection (at the investigator´s discretion).
- •Serious concomitant seismic disorders including uncontrolled diabetes mellitus) incompatible with the study (at the discretion of the investigator).
- •Second primary neoplasia (except carcinoma in situ cervix or basal cell carcinoma to adequately treated skin or squamous cell carcinoma to the skin without relapse for 5 previous years).
- •Bone metastasis, pleural effusions, or ascites as the sole focus of disease.
- •Bone marrow transplant or autologous cell stem infusion followed by high dose chemotherapy for adjuvant or metastatic disease.
- •Radiation greater than 20% of total bone marrow producing areas
- •Concurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy (including humanized HER2 antibody).
- •History of hypersensitive reactions with drugs formulated in Cremophor EL (polyoxyethylated castor oil).
- •Treatment with a drug within the last 30 days that has not received regulatory approval at the time of entry to the study.
- •Presence of severe psychiatric illness.
- •Pregnancy or breastfeeding.
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