LBCTR2019060241已完成2 期
A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
ovartis Pharma Services Inc.0 个研究点目标入组 5 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 至 59（—）
- 性别
- Female
入选标准
- •1.Patient is an adult female = 18 years old and < 60 years old at the time of informed consent.
- •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% ER positive or Allred =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
- •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 PI's 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. OR
- •?If on tamoxifen within the past 14 days, plasma estradiol must be = 10 pg/mL and/or FSH = 40 IU/l or in the premenopausal range, according to local laboratory definition.
- •?In case of therapy induced amenorrhea, with a plasma estradiol =10 pg/mL and/or FSH =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 = 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.
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 = 14 days of tamoxifen or NSAI or LHRH agonists = 28 days for advanced breast cancer prior to randomization are eligible.
- •2.Patient has received extended-field radiotherapy or limited field radiotherapy = 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 investigator's discretion). Patient from whom = 25% 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.
- •4.Patients who have lung metastases with oxygen demand in resting status.
- •5.Patients who have liver metastases with bilirubin > 1.5 mg/dL
- •6.Patients with CNS involvement unless they meet ALL of the following criteria:
- •?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
相似试验
进行中（未招募）
1 期
The effect of anti-latency reversing therapy and broadly neutralizing antibodies on the HIV-1 reservoir in patients on antiretroviral therapy - a randomized trial (ROADMAP)HIV infectionMedDRA version: 20.0Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 100000004848MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-005238-23-DKRockefeller University30
进行中（未招募）
1 期
A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP).EUCTR2015-005238-23-DEThe Rockefeller University30
招募中
不适用
A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary PeritonealKCT0004526Asan Medical Center350
进行中（未招募）
2 期
A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)carcinoma, ovarian epithelialD000077216JPRN-jRCT2031190097Fujiwara Keiichi24
进行中（未招募）
不适用
Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium. - JASINT 1Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]MedDRA version: 9.1Level: LLTClassification code 10044412EUCTR2010-020620-22-ITPIERRE FABRE MEDICAMENT68