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临床试验/CTRI/2016/06/007016
CTRI/2016/06/007016已完成3 期

A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment

ovartis Healthcare Private Limited0 个研究点目标入组 6 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
6
研究概览入排标准研究者记录与标识符相似试验

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. Patient is an adult = 18 years old at the time of informed consent and has signed informed
  • •consent before any trial related activities and according to local guidelines.
  • •2. Patient has adequate tumor tissue for the analysis of PIK3CA mutational status by a
  • •Novartis designated laboratory. One new or recent biopsy(collected at screening if feasible) or archival tumor block or slides(15 slides
  • •minimum from a surgical specimen, 20 slides minimum from a biopsy) must be provided. it is recommended to provide a tumor sample collected after the most recent progression or recurrence.
  • •3. Patient has identified PIK3CA status (mutant or non-mutant; determined by a Novartis
  • •designated laboratory).
  • •4. If female, then the patient is postmenopausal. Postmenopausal status is defined either by:
  • •a. Prior bilateral oophorectomy
  • •b. Age less than or equal to 60
  • •c. Age greater than 60 and amenorrheic for 12 or more months in the absence of chemotherapy,
  • •tamoxifen, toremifene, or ovarian suppression and Follicle-stimulating Hormone
  • •(FSH) and estradiol in the postmenopausal range per local normal range.
  • •5. Patient has radiological or objective evidence of recurrence or progression.
  • •6. Patient has a histologically and/or cytologically confirmed diagnosis of ER positive and/or PgR positive breast cancer by local laboratory.
  • •7. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or
  • •an IHC status of 0, 1 positive or 2 positive.If IHC is 2 positive,a negative in situ hybridization (FISH, CISH, or
  • •SISH) test is required by local laboratory testing.
  • •8. Patient has either:
  • •a. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (a
  • •lesion at a previously irradiated site may only be counted as a target lesion if there is
  • •clear sign of progression since the irradiation ) OR
  • •b. If no measurable disease is present, then at last one predominantly lytic bone lesion
  • •must be present (patients with no measurable disease and only one predominantly
  • •lytic bone lesion that has been previously irradiated are eligible if there is documented
  • •evidence of disease progression of the bone lesion after irradiation).
  • •9. Patient has advanced (loco regionally recurrent not amenable to curative therapy or
  • •metastatic) breast cancer.
  • •Patients may be:
  • •a.relapsed with documented evidence of progression while on or after
  • •completion of (neo)adjuvant endocrine therapy with no treatment for metastatic
  • •b.relapsed with documented evidence of progression more than 12 months from
  • •completion of adjuvant endocrine therapy and then subsequently progressed with
  • •documented evidence of progression after one line of endocrine therapy for metastatic
  • •c.newly diagnosed advanced breast cancer, then relapsed with documented evidence of
  • •progression while on or after one line of endocrine therapy.
  • •10. Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole,
  • •anastrozole, exemestane). AI therapy does not need to be the latest treatment regimen.
  • •11. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • •12. Patient has adequate bone marrow and organ function as defined by the following <br/

排除标准

  • •1. Patient with symptomatic visceral disease or any disease burden that makes the patientineligible for endocrine therapy per the investigator’s best judgment.
  • •2. Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant
  • •chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor
  • •3. Patient has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients
  • •of alpelisib or fulvestrant.
  • •4. Patient with inflammatory breast cancer at screening.
  • •5. Patient is concurrently using other anti-cancer therapy.
  • •6. Patient has had surgery within 14 days prior to starting study drug or has not recovered
  • •from major side effects.
  • •7. Patient has not recovered from all toxicities related to prior anticancer therapies to NCI
  • •CTCAE version 4.03 Grade less than or equal to 1. Exception to this criterion: patients with any grade of
  • •alopecia are allowed to enter the study.
  • •8. Patients with Child pugh score B or C.
  • •9. Patient has received radiotherapy less than or equal to 4 weeks or limited field radiation for palliation less than or equal to 2
  • •weeks prior to randomization, and who has not recovered to grade 1 or better from related
  • •side effects of such therapy (with the exception of alopecia) and/or from whom greater than or equal to 25percentage of
  • •the bone marrow was irradiated.
  • •10. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with
  • •the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • •11. Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
  • •(based on FPG and HbA1c, see inclusion criterion 12)
  • •12. Patient has impairment of gastrointestinal (GI) function or GI disease that may
  • •significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled
  • •nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • •13. Patient has a known history of Human Immunodeficiency Virus (HIV) infection (testing
  • •not mandatory)
  • •14. Patient has any other concurrent severe and/or uncontrolled medical condition that would,
  • •in the investigator’s judgment, contraindicate patient participation in the clinical study (e.g chronic active hepatitis, severe hepatic impairment, etc.)
  • •15. Patient has currently documented pneumonitis (the chest CT scan performed at baseline
  • •for the purpose of tumor assessment should be reviewed to confirm that there are no
  • •relevant pulmonary complications present).
  • •16. Patient has clinically significant, uncontrolled heart disease and/or recent cardiac events
  • •including any of the following:
  • •a.History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within
  • •12 months prior to study entry
  • •b. History of documented congestive heart failure (New York Heart Association
  • •functional classification III-IV)
  • •c. Documented cardiomyopathy
  • •d.Patient has a Left Ventricular Ejection Fraction (LVEF) less than 50percentage as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
  • •d.History of any cardiac arrhythmias, (e.g., ventricular tachycardia),complete left bundle block, high

研究者

发起方
ovartis Healthcare Private Limited

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