A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
- Conditions
- HER2-positive Breast Cancer
- Sponsor
- Shandong University
- Enrollment
- 268
- Primary Endpoint
- Percentage of Participants With Pathological Complete Response (pCR)
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Detailed Description
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy. It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy. The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
Investigators
Yu-Zhi Gang
Director
The Second Hospital of Shandong University
Eligibility Criteria
Inclusion Criteria
- •female patients, 18 years ≤ age ≤75 years；
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Histologically confirmed invasive breast cancer（early stage or locally advanced）
- •HER2 positive (HER2+++ by IHC or FISH+)
- •Known hormone receptor status.
- •Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- •Signed informed consent form (ICF)
Exclusion Criteria
- •Metastatic disease (Stage IV) or inflammatory breast cancer.
- •Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
- •Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- •Unable or unwilling to swallow tablets.
Arms & Interventions
Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
Intervention: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin
Outcomes
Primary Outcomes
Percentage of Participants With Pathological Complete Response (pCR)
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
- Event-free survival(Following surgery until Year 3)
- Disease-free Survival(Following surgery until Year 3)
- Distance Disease-free Survival(Following surgery until Year 3)
- Objective Response Rate(Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months)