Randomized Phase II Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 40
- 主要终点
- Progression Free Survival Using the RECIST 1.1 Criteria
研究概览
简要总结
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.
详细描述
The standard or usual treatment of this type of breast cancer is endocrine therapy. Palbociclib is a new type of drug for breast cancer. Laboratory tests as well as studies in animals and people show that it may help slow the growth of breast cancer. The most widely tested regimen of Palbociclib for patients with metastatic/advanced breast cancer is 125 mg every day for 21 days out of a 28 day cycle in combination with standard endocrine (hormone) therapy. This study explores if administering a lower dose of palbociclib - 100 mg given every day of a 28 day cycle in combination with standard endocrine (hormone) therapy - may result in more tumour shrinkage and be better tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal and postmenopausal women 18 years of age or older.
- •Histologically confirmed adenocarcinoma of the breast, with ER positive and HER2 negative status based on local testing on most recent pathological tumour specimen.
- •Patients must satisfy the following criteria for prior therapy:
- •Progressed during treatment or within 12 months of completion of adjuvant endocrine therapy or
- •Progressed during prior endocrine therapy for advanced/metastatic disease. Note: 'Progressed during endocrine therapy' means that the patient progressed while on or within 1 month after discontinuation of endocrine therapy.
- •One line of chemotherapy for advanced/metastatic disease (regardless of prior adjuvant chemotherapy use) is allowed in addition to endocrine therapy.
- •Patients must have evidence of disease to be eligible for the study, but measurable disease is not mandatory.
- •For those patient with measureable disease who will be included in the response assessment, the following criteria must apply:
- •X-ray ≥ 20 mm
- •Spiral CT scan or physical exam ≥ 10 mm (lymph nodes must be ≥ 15 mm in the short axis)
- •Conventional CT scan, MRI ≥ 20 mm
- •Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.
- •Tumor lesions previously irradiated or subjected to other loco regional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.
- •Eastern Cooperative Oncology Group (ECOG) 0-
- •Adequate organ and bone marrow function as defined by:
- •ANC ≥ 1,500/mm3 (1.5 x 109/L)
- •Platelets ≥ 100,000/mm3 (100 x 109/L)
- •Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥60 ml/min as calculated using the method standard for the institution;
- •Total serum bilirubin ≤ 1.5 x ULN (<3 ULN if Gilbert's disease).
- •Patient must agree to provide tumour tissue from the most recent pathological tumour specimen.
- •Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
- •Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
- •Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.
- •In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient randomization.
- •Women of childbearing potential must have agreed to use a highly effective contraceptive method.
排除标准
- •Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term.
- •Patients with symptomatic CNS involvement, meningeal or parenchymal, that is uncontrolled or requires steroids.
- •Prior treatment with any CDK 4/6 inhibitor.
- •Prior treatment with mTOR inhibitors.
- •Active second malignancy, regardless of ongoing treatment.
- •Any concurrent medical condition that in the opinion of the investigator would interfere with the safe administration of the study drug and participation in the study.
- •Participation in a prior anti-cancer investigational study within 30 days prior to enrollment.
研究组 & 干预措施
Palbociclib (125mg)
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
干预措施: Fulvestrant or Tamoxifen or Aromatase Inhibitor (Drug)
Palbociclib (125mg)
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
干预措施: Palbociclib 125mg (Drug)
Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
干预措施: Fulvestrant or Tamoxifen or Aromatase Inhibitor (Drug)
Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
干预措施: Palbociclib 100mg (Drug)
结局指标
主要结局
Progression Free Survival Using the RECIST 1.1 Criteria
时间窗: 2 years
progression free survival (PFS) is defined as time from randomization to progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Duration of Response(2 years)
- Overall Survival(2 years)
- Number of Participants With Response or No Response(2 years)