HER2 Positive Breast Cancer Clinical Trial
Official title:
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Early Stage or Locally Advanced Breast Cancer Patients.
Verified date | May 2019 |
Source | Henan Cancer Hospital |
Contact | xiuchun Chen |
Phone | 18603719919 |
cxc701024[@]163.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2 positive early stage or locally advanced breast cancer.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | December 30, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 1. female patients, 18 years = age = 75 years. 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1. 3. Histologically confirmed invasive breast cancer:early stage or locally advanced,Primary tumour greater than 2 cm diameter 4. HER2 positive (HER2+++ by IHC or FISH+) 5. Subjects received neoadjuvant therapy with trastuzumab 2 weeks post-imaging evaluation Patients with a price of PD or SD. 6. Known hormone receptor status. 7. Required laboratory values including following parameters: ANC: = 1.5 x 10^9/L;Platelet count: = 100 x 10^9/L;Hemoglobin: = 9.0 g/dL;Total bilirubin: = 1.5 x upper limit of normal (ULN);ALT and AST: = 1.5 x ULN (or = 5×ULN in patients with liver metastases);BUN and creatine clearance rate: = 50 mL/min;LVEF: = 50%;QTcF: < 470 ms for female and < 450 ms for male. 8. Signed the informed consent form prior to patient entry. Exclusion Criteria: - 1. metastatic disease (Stage IV) or inflammatory breast cancer. 2. 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. 3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension =180/110); 4. Unable or unwilling to swallow tablets. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | Objective Response Rate | [Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months | |
Secondary | Pathological Complete Response (pCR) | Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated | Time Frame: through study completion, an average of 1 year | |
Secondary | EFS | Event-free survival | Time Frame: Following surgery until Year 5 | |
Secondary | DFS | Disease-free Survival | Time Frame: Following surgery until Year 5 | |
Secondary | DDFS | Distance Disease-free Survival | Time Frame: Following surgery until Year 5 |
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