CTRI/2015/07/006016尚未招募未知
An observational study to assess the safety and efficacy of Maintenance Metronomic Chemotherapy (MMCT) of low-dose oral Cyclophosphamide and Methotrexate after first line or second line chemotherapy for Metastatic Triple Negative Breast cancer (TNBC)
Jehangir Clinical Development centre Pvt ltd0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Females above 18 years and < 80 years of age.
- •2.Patients who are being prescribed (by their treating oncologists) metronomic therapy within 6 weeks of completion of 1st/2nd line chemotherapy for TNBC.
- •3.Women with triple negative phenotype [Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) negative invasive breast cancer confirmed on IHC] with metastatic disease (based on chest, abdominal, bone imaging performed within 3 months prior to screening).
- •[Note: HER2 negative by FISH or HER2 0 or 1+ by IHC].
- •4.Unidimensionally measurable disease according to RECIST 1.1.
- •5.Pre-treated with not more than 1 regimen in metastatic setting.
- •6.Peripheral WBC count >= 3,000 mm3, absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3 based on previous reports within 15 days from screening.
- •7.Normal myocardial left ventricular function > 50% based on previous reports within 6 months from screening.
- •8.Must have an adequate renal function (serum creatinine <= 2 X upper limits normal) and good hepatic function (total bilirubin and SGPT/SGOT <=2.5 X upper limits normal for subjects without liver metastasis or <=5 X upper limits normal for subjects with liver metastasis) within 15 days from screening.
- •9.Must be in good general health (Eastern Cooperative Oncology Group (ECOG)) performance <= 2.
- •10.Life expectancy > 6 months.
- •11.Must be willing to or likely to comply with all study requirements.
- •12.Must be able and willing to provide written informed consent.
- •13.Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use acceptable method of contraception during the study.
排除标准
- •1.If a subject has a biopsy done at the time of metastasis, showing a receptor change.
- •2.Inflammatory breast cancer (T4d).
- •3.Active brain metastasis. (If the subject has brain metastasis which is treated and stable, s/he is eligible).
- •4.Another active cancer present.
- •5.Known contraindications to receive cyclophosphamide or methotrexate or any medical condition where the subject may be unable to swallow.
- •6.Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin.
- •7.Pregnant or breast-feeding women.
- •8.Known HIV infection.
- •9.Currently participating or had participated in other interventional study for last 3 months prior to screening.
- •10.Any other clinically significant medical condition e.g. active infections, cardiac, psychiatric, neurological, pulmonary or immunological conditions etc. which may, in the judgment of the investigator, interfere with the subjectâ??s ability to participate in the study.
研究者
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