CTRI/2019/09/021333招募中2 期
A phase II randomized study of the combination ofRibociclib plus goserelin acetate with Hormonal Therapyversus physician choice chemotherapy in premenopausalor perimenopausal patients with hormone receptorpositive/HER2-negative inoperable locally advanced ormetastatic breast cancer - RIGHT Choice Study
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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 female 18 years old to 60 years old at the time of informed consent. Written informed consent must be obtained
- •prior to any screening procedures
- •2. Patient has a histologically and or cytologically confirmed diagnosis of estrogen receptor positive and or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should be more than 10 percent ER
- •positive or Allred more than or equal to 5 by local laboratory testing.
- •3. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 or 2. If IHC is 2, a
- •negative in situ hybridization FISH, CISH, or SISH test is required by local laboratory testing and based on the most recently analyzed
- •tissue sample.
- •4. Women with advanced locoregionally recurrent or metastatic breast cancer not amenable to curative therapy. Patients must fulfill at least
- •one of the following criteria to be considered that combination chemotherapy is needed according to PIs judgment
- •Symptomatic visceral metastases
- •Rapid progression of disease or impending visceral
- •compromise.
- •Markedly symptomatic non visceral disease if the treating physician opt to give chemotherapy for rapid palliation of patients symptoms.
- •5. Patient is premenopausal or perimenopausal at the time of study entry.
- •a. Premenopausal status is defined as either:
- •Patient had last menstrual period within the last 12 months.
- •If on tamoxifen within the past 14 days, plasma estradiol must be more than 10 pg/mL and or FSH less than 40 IU/l or in the premenopausal range, according to local laboratory definition.
- •In case of therapy induced amenorrhea, with a plasma estradiol more than 10 pg/mL and or FSH less than 40 IU/l or in the premenopausal range according to local laboratory
- •definition.
- •Patients who have undergone bilateral oophorectomy are not eligible.
- •b. Perimenopausal status is defined as neither premenopausal nor postmenopausal
- •6. Patients must have not received any prior hormonal therapy and chemotherapy for advanced breast cancer, except LHRH agonist.
- •Patients who received less than 14 days of tamoxifen or a NSAI (letrozole or anastrozole) with or without LHRH agonist for advanced breast cancer prior to randomization are eligible. Patient must have 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 a clear sign of progression since the irradiation)
排除标准
- •1. Patient has received prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy, or any CDK4 6 inhibitor for
- •advanced breast cancer.
- •Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included aromatase inhibitors, the disease free interval must be greater
- •than 12 months from the completion of aromatase inhibitor treatment until randomization.
- •Patients who are receiving less than 14 days of tamoxifen or NSAI or LHRH agonists less than 28 days for advanced breast cancer prior to
- •randomization are eligible.
- •2. Patient has received extended field radiotherapy or limited field radiotherapy less than 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy with the
- •exception of alopecia or other toxicities not considered a safety risk for the patient at investigators discretion. Patient from whom more than 25 percent of the bone marrow has been previously irradiated are also excluded.
- •3. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal or
- •squamous cell skin carcinoma non melanomatous skin cancer or curatively resected cervical cancer.
- •Note CNS involvement must be ruled out by assessments if a patient has
- •any signs or symptoms indicating potential central nervous system metastases.
- •4. Patients who have lung metastases with oxygen demand in resting status.
- •5. Patients who have liver metastases with bilirubin more than 1.5 mg/dL
- •6. Patients with CNS involvement unless they meet ALL of the following
- •At least 4 weeks from prior therapy completion including radiation and or surgery to starting the study treatment.
- •Clinically stable CNS tumor at the time of screening and not receiving steroids and or enzyme inducing anti epileptic medications for brain metastases.
- •Leptomeningeal metastases is not allowed, even with stable clinical condition.
研究者
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