A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

University of Michigan Rogel Cancer Center6 个研究点分布在 1 个国家目标入组 30 人2024年2月27日

适应症Breast Cancer

干预措施Postoperative Radiation Therapy Ribociclib

概览

阶段: 1 期
干预措施: Postoperative Radiation Therapy
疾病 / 适应症: Breast Cancer
发起方: University of Michigan Rogel Cancer Center
入组人数: 30
试验地点: 6
主要终点: Dose limiting toxicity (DLT) of ribociclib administered concurrently with adjuvant RT 1 month post last RT dose
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer.

Once enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate standard of care adjuvant radiation therapy- 50 Gy in 25 fractions or 42.56 Gy in 16 fractions +/- 10 Gy boost including comprehensive nodal. Paitents will continue treatment with Ribociclib for up to 6 weeks.

注册库

clinicaltrials.gov

开始日期

2024年2月27日

结束日期

2030年6月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

Female

研究者

发起方

University of Michigan Rogel Cancer Center

责任方

Sponsor

入排标准

入选标准

•ER and/or PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with \> 3 lymph nodes involved on sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) OR have between 1-3 lymph nodes involved AND have T3 disease OR have between 1-3 lymph nodes involved and grade 3 breast cancer.
•Patients must have undergone gross total excision of all locoregional disease with negative margins (i.e. no tumor on ink). At least 21 days must elapse between surgical treatment for breast cancer and initiation of study treatment.
•Patients must have completed chemotherapy (either in neoadjuvant or adjuvant setting). If received adjuvant chemotherapy, chemotherapy must have completed at least 21 days prior to initiation of study treatment.
•Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and surgical side effects following definitive breast surgery except for neuropathy and alopecia
•Adequate baseline hematologic, hepatic and renal function as indicated below:
•Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by central laboratory for eligibility):
•Absolute neutrophil count ≥ 1.5 × 109/L
•Platelets ≥ 100 × 109/L
•Hemoglobin ≥ 9.0 g/dL
•INR ≤1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)

排除标准

•Prior history of radiation therapy to the chest wall and/or regional nodes is not allowed (but prior radiation therapy to other sites is permissible).
•Prior history of CDK4/6 inhibitor therapy.
•Patients who are pregnant or breastfeeding.
•Because radiation is known to be teratogenic, women of childbearing potential must have a documented negative pregnancy test performed prior to the start of study therapy (as above) and agree to use adequate contraception (hormonal or double barrier method of birth control; vasectomized partner; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
•Patient with distant metastases of breast cancer beyond regional lymph nodes and/or evidence of breast cancer recurrence prior to study enrollment.
•Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
•History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.
•Documented cardiomyopathy.
•Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)
•Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

研究组 & 干预措施

RT + Ribociclib

All patients will be treated with Ribociclib and standard of care radiation therapy

干预措施: Postoperative Radiation Therapy

RT + Ribociclib

All patients will be treated with Ribociclib and standard of care radiation therapy

干预措施: Ribociclib

结局指标

主要结局

Dose limiting toxicity (DLT) of ribociclib administered concurrently with adjuvant RT 1 month post last RT dose

时间窗: up through 30 days after the last dose of study drug or radiotherapy

Safety evaluations will be based on the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. Safety variables will be tabulated and presented for all patients in the study. Exposure to study drug and reasons for discontinuation of study treatment will be tabulated.

次要结局

Cumulative incidence of local failure (i.e. local recurrence events)(up through 2 years after completion of protocol therapy)
Recurrence-free survival(up through 2 years after completion of protocol therapy)
Overall survival(up through 2 years after completion of protocol therapy)
Disease free survival(up through 2 years after completion of protocol therapy)
Local failure-free survival(up through 2 years after completion of protocol therapy)