A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
概览
- 阶段
- 2 期
- 干预措施
- Abemaciclib
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Dana-Farber Cancer Institute
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective Response Rate
- 状态
- 终止
- 最后更新
- 2个月前
概览
简要总结
This research study is studying a drug called Abemaciclib as a possible treatment for have metastatic triple-negative type of breast cancer.
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease. Some triple-negative breast cancers show expression of the Rb protein and are referred to as "Rb-positive." The Rb protein is important because it controls the way that cancer cells divide and grow. Drugs like abemaciclib work by changing the way that Rb functions. This can potentially stop cancer cells from dividing, and can also potentially lead to cancer cell death. In this research study, the investigators are are looking to see how safe abemaciclib is and how well it will work to help people with triple-negative breast cancer that is Rb-positive.
研究者
Sara Tolaney, MD
Principal Investigator
Dana-Farber Cancer Institute
入排标准
入选标准
- •Patients must have histologically or cytologically confirmed invasive breast cancer, which is recurrent, locally advanced, unresectable or metastatic.
- •Patients must have at least one lesion that is not within a previously radiated field and that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scans per RECIST version 1.
- •Bone lesions are not considered measurable.
- •Either the primary tumor and/or metastatic tumor must be triple-negative on the most recent sample as defined below:
- •Hormone receptor status: the invasive tumor must be ER- and PR-negative, or staining present in \<1% by immunohistochemistry (IHC)
- •HER2 status: the invasive tumor must be Human Epidermal Growth Factor Receptor 2 Negative (HER2-negative) by the ASCO CAP guidelines
- •Either the primary tumor and/or the metastatic tumor must be RB positive as defined below:
- •-RB status: the invasive tumor must have greater than 50% of tumor cells staining positive for RB.
- •Prior Chemotherapy:
- •Patients may have received 1-3 prior systemic therapies for metastatic disease (note: for patients who have first developed recurrent/metastatic disease within 12 months of completing any (neo)-adjuvant therapy for triple-negative breast cancer, the (neo)-adjuvant therapy is counted as a prior line of therapy).
排除标准
- •Received a prior CDK4/6 inhibitor.
- •Undergone major surgery within 14 days of the initial dose of study drug
- •Received another investigational agent (defined as any agent/device that has not received regulatory approval for any indication) within 14 days of the first dose of study drug for a nonmyelosupressive agent, or 21 days of the first dose of study drug for a myelosuppressive agent.
- •Has any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator.
- •Has an active bacterial, fungal, and/or known viral infection. Patients with known HIV infection are excluded given the potential for interactions between antiretroviral agents and abemaciclib, and the potential for increased risk of life-threatening infection with therapy that is myelosuppressive. Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable Hepatitis C RNA)
- •Documented brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Participants with previously diagnosed brain metastases are eligible if they have completed treatment at least one month prior to trial registration, are neurologically stable, and have recovered from effects of radiotherapy or surgery.
- •Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥2 weeks before the first study drug.
- •Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery, or a combination as was deemed appropriate by the treating physician.
- •Patients who meet the above criteria and are clinically stable on anti-convulsant medication are eligible only if their anti-convulsant does not alter hepatic cytochrome P450 activity in a way that might interfere with metabolism of abemaciclib.
- •Pregnant women are excluded from this study because of the potential for teratogenic effects.
研究组 & 干预措施
Abemaciclib
-Abemaciclib will be administered orally, twice daily on days 1 to 28
干预措施: Abemaciclib
结局指标
主要结局
Objective Response Rate
时间窗: 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Overall Response Rate(ORR) = (CR + PR)/sample size.
次要结局
- Overall Survival(Baseline to date of death due to any cause, or at date last known alive.Participants will be followed once every 6 months until death.Those removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization.)
- Progression Free Survival(Baseline to the earlier of progression (per Response Evaluation Criteria in Solid Tumors 1.1), date of death due to any cause, or date of last disease evaluation. Participants will be followed up up to 16.5 months.)
- Disease Control Rate(2 years)
- Clinical Benefit Rate(2 years)