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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03947242
Other study ID # HR-NeoBC-HN003
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date December 30, 2020

Study information

Verified date May 2019
Source Henan Cancer Hospital
Contact xiuchun Chen
Phone 18603719919
Email cxc701024@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Vinorelbine given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pyrotinib and Trastuzumab plus Vinorelbine
Pyrotinib:400mg orally daily Trastuzumab:8mg/kg ivgtt load followed by 6mg/kg ivgtt 3-weekly for a total of 4 cycles Vinorelbine :25mg/m2 ivgtt 3-weekly for a total of 4 cycles,d1 d8

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Henan Cancer Hospital

Outcome

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
See also
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Active, not recruiting NCT02993198 - A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging Phase 2