CTRI/2018/06/014620招募中2 期
A multicentric open label phase II safety and efficacy study of ormeloxifene in tamoxifen resistant metastatic/recurrent breast cancer patients. -
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
- •1.Ability to provide written informed consent for participation in the study.
- •2.Female patients with ââ?°Â¥ 18 years, Who are either
- •premenopausal as confirmed by no irregularities in last three consecutive menstrual periods OR serum
- •estrogen (E2) level that is the premenopausal range. OR Who were premenopausal at the time of diagnosis of breast cancer but who have undergone bilateral oophorectomy and/or radiotherapy ovarian
- •ablation and/or gonadotropin releasing hormone agonist treatment, as part of treatment for breast
- •3.Histologically or cytologically confirmed breast cancer from most recent historical reports of
- •histopathology.
- •4.Immunohistochemistry (IHC) evidence of estrogen receptor positive (allred score of >3/8) and IHC or FISH evidence of negative cerb B2 status.
- •5.IHC or FISH evidence for negative Cerb B2 status
- •Ã¢â?¬Â¢In case of historical reports of IHC confirming evidence of ER-positive and Cerb B2 negative status, a repeat IHC is not required.
- •6.Patients whose cancer has evidence of tamoxifen resistance as suggested by at least one of the following:
- •i)Development of recurrence of and/or metastasis while patient on adjuvant tamoxifen
- •ii)Development of recurrence of and/or metastasis within one year of completing adjuvant tamoxifen.
- •iii)Progression of metastatic/recurrent disease while patient was on tamoxifen or progression of metastatic/recurrent disease within 6 months of stopping tamoxifen.
- •7.Stage I: Patient treated with not more than 2 chemotherapy regimens, including (neo) adjuvant chemo regimens.
- •Stage II: Patient treated with not more than 4 chemotherapy regimens, including (neo) adjuvant chemo regimens.
- •8.Patients should have at least one measurable lesion as defined by RECIST criteria (version 1.1).
- •9.Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •10.Patients with normal liver, kidney and marrow function, resolution of all toxic effects of prior therapy or surgical procedures, as per the investigatorââ?¬•s clinical judgement.
- •11.Life expectancy of at least 6 months in the opinion of the investigator.
排除标准
- •1.Patients with extensive advanced, symptomatic visceral disease that requires chemotherapy.
- •2.Patients with known uncontrolled or symptomatic CNS metastases.
- •3.Patients with major surgery or any anti-cancer therapy within 2 weeks prior to enrolment.
- •4.History of prior invasive malignancy, except breast cancer or non-melanoma skin cancer.
- •5.Women of childbearing potential without adequate contraception.
- •Ã¢â?¬Â¢Unwilling to use at least one reliable method of contraception (e.g., a barrier method [condom or occlusive cap] with spermicidal foam/gel/film/cream/suppository, a non-hormone releasing intrauterine device or intrauterine system, sterilisation of sole male partner, abstinence) throughout the study period and for 6 months after the last study drug treatment.
- •Ã¢â?¬Â¢Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy during the study is not allowed.
- •6.Women who are pregnant or breast feeding.
- •7.Women in their post-menopausal state - a period of continuous absence of menstrual cycles for 12 months or more as calculated at the time of screening
- •8.Any history of cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not limited to: active cardiac disease - angina pectoris that requires the use of anti-anginal medication; recent history of unstable angina or myocardial infarction within last 6 months, ventricular arrhythmias except for benign premature ventricular contractions; supra ventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic congestive heart failure or pericarditis; history of cardiac disease - myocardial infarction documented by elevated cardiac enzymes, or a cardiac troponin or cardiac myoglobin or persistent regional wall abnormalities on assessment of left ventricular function; New York Heart Association (NYHA) class III or IV congestive heart failure; and/or documented cardiomyopathy.
- •9.Acute or active chronic infections which, in the opinion of the Investigator, may affect patient safety or participation in the study.
- •10.Known history of alcohol/drug abuse.
- •11.Known history of allergy to any of the study treatments.
- •12.History of stem cell or bone marrow transplantation.
- •13.Active use of potent CYP3A4 inhibitors or inducers (e.g. carbamazepine, dexamethasone and ethosuximide; cimetidine, amiodarone, azithromycin etc.).
- •14.Participation in any other clinical study or administration of any other investigational medications within 30 days of enrolment or 5 half- lives, whichever is longer.
研究者
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