Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03947242
• Other study ID #: HR-NeoBC-HN003
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Breast Cancer

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