A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- ctDNA clearance after one cycle neoadjuvant treatment
Overview
Brief Summary
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
- •No prior treatment
Exclusion Criteria
- •Bilateral or metastatic breast cancer
- •History of other malignancies
- •Severe cardiovascular disease
- •Allergic to any of the regimens
Arms & Interventions
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
Intervention: pyrotinib (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
Intervention: pertuzumab (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
Intervention: trastuzumab (Drug)
Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
Intervention: docetaxel (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
Intervention: pertuzumab (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
Intervention: trastuzumab (Drug)
Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
Intervention: docetaxel (Drug)
Outcomes
Primary Outcomes
ctDNA clearance after one cycle neoadjuvant treatment
Time Frame: 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
Secondary Outcomes
- ctDNA clearance after two cycle neoadjuvant treatment(3 months after neoadjuvant treatment initation)
- pCR rate(6 months after neoadjuvant treatment initation)
- bpCR rate(6 months after neoadjuvant treatment initation)
- ORR(6 months after neoadjuvant treatment initation)
- EFS(2 years after surgery)
- DFS(2 years after surgery)
- OS(5 years after surgery)
Investigators
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine