Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HER2 therapy disease-free survival
研究概览
简要总结
Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline.
Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.
详细描述
Patients with HER2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included.
Blood samples will be collected at baseline (before neoadjuvant start) for the analysis of CTCs and its positivity for HER2 by IHC and ISH.
Patients with pathological complete response will be included in the randomization phase of the study. There will be 2 cohorts: HER2 positive CTCs at baseline and HER2 negative/absent CTCs at baseline. In each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HER2 positive breast cancer (hormone receptors positive or negative)
- •Stage I to III
- •Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
- •Breast surgery after neoadjuvant therapy
- •Preserved coagnition
- •For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)
- •Agreement on participation and signature of de ICF
排除标准
- •Contradindication for trastuzumab or pertuzumab
- •Adjuvant chemotherapy. Hormone therapy is allowed
- •Second primary tumor < 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer
研究组 & 干预措施
Cohort 1, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
干预措施: Trastuzumab (Drug)
Cohort 1, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
干预措施: Circulating tumor cells (Other)
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
干预措施: Pertuzumab (Drug)
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
干预措施: Trastuzumab (Drug)
Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
干预措施: Circulating tumor cells (Other)
Cohort 2, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
干预措施: Trastuzumab (Drug)
Cohort 2, Arm A - trastuzumab
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
干预措施: Circulating tumor cells (Other)
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
干预措施: Pertuzumab (Drug)
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
干预措施: Trastuzumab (Drug)
Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
干预措施: Circulating tumor cells (Other)
结局指标
主要结局
HER2 therapy disease-free survival
时间窗: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
CTCs disease-free survival
时间窗: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
次要结局
- Correlation of CTCs and pathological complete response(At baseline)
- Prognostic factors for disease-free survival(At baseline and adjuvant therapy (18 months))
- Adverse events(Adjuvant period (1 year))
研究者
Marcelle Goldner Cesca
Clinical Oncologist
AC Camargo Cancer Center