A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers
概览
- 阶段
- 2 期
- 干预措施
- SOC Chemotherapy
- 疾病 / 适应症
- Metastatic Breast Cancer
- 发起方
- Kathy Miller
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- Overall response rate
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.
详细描述
Randomized phase II using a two-stage Bayesian optimal phase II two-arm design (BOP2). Patients are randomized 1:1 to either the monotherapy or combination arms. This requires 42 patients (21 per treatment arm) in stage I for each race-based cohort. If the no. of response in experimental - no. of response in control is no greater than -1, the trial is early stopped at stage I for futility. Otherwise, additional 42 patients for each race-based cohort will be enrolled and randomized to the study in stage II.
研究者
Kathy Miller
Ballvé-Lantero Professor of Medicine
Indiana University
入排标准
入选标准
- •≥ 18 years old at the time of informed consent
- •Ability to provide written informed consent and HIPAA authorization
- •Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-low (ER and PR ≤ 9% weak staining)
- •Received up to 2 prior therapies for metastatic disease
- •Prior (neo)adjuvant therapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of completion of (neo)adjuvant therapy.
- •Participation in this protocol as either first, second and third-line therapy is allowed.
- •Planned standard of care chemotherapy based on NCCN guidelines.
- •Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.
- •Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents.
- •Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.
排除标准
- •Prior treatment with or known contraindication to treatment with tocilizumab or other IL-6/IL-6R targeted agent
- •Active infection requiring parenteral antibiotics
- •Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
- •Active or symptomatic CNS disease
- •Patients with HER2+ disease Note: HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \> 2.0 or \> 6 total HER2 gene copies per cell.
- •Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded
- •Radiation therapy within 2 weeks of registration
- •Hormone therapy within 2 weeks of registration
- •Planned treatment with Olaparib or other PARP inhibitor.
研究组 & 干预措施
Black Monotherapy
干预措施: SOC Chemotherapy
Black Combination treatment
干预措施: SOC Chemotherapy
Black Combination treatment
干预措施: Tocilizumab
Non-Black Monotherapy
干预措施: SOC Chemotherapy
Non-Black Combination treatment
干预措施: SOC Chemotherapy
Non-Black Combination treatment
干预措施: Tocilizumab
结局指标
主要结局
Overall response rate
时间窗: through study completion (i.e. up to 2 years)
Efficacy of tocilizumab in Black and non-Black patients
时间窗: through study completion (i.e. up to 2 years)
efficacy defined as using the difference in difference approach across race based cohorts
Progression-free survival
时间窗: through study completion (i.e. up to 2 years)
次要结局
- Safety of SOC chemotherapy monotherapy compared to SOC chemotherapy combined with tocilizumab using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0(through study completion (i.e. up to 2 years))
- Evaluate the differences in inflammatory pathways between Black and non-Black patients(Baseline)
- Evaluate the impact of Duffy genotype on efficacy in Black patients(Baseline)