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

Primary Purpose

HER2 Positive Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Pyrotinib and Trastuzumab plus Vinorelbine

About this trial

This is an interventional treatment trial for HER2 Positive Breast Cancer focused on measuring Trastuzumab-refractory

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib + trastuzumab +Vinorelbine

Arm Description

Pyrotinib in Combination With Trastuzumab Plus Vinorelbine

Outcomes

Primary Outcome Measures

ORR

Objective Response Rate

Secondary Outcome Measures

Pathological Complete Response (pCR)

Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated

EFS

Event-free survival

DFS

Disease-free Survival

DDFS

Distance Disease-free Survival

Full Information

NCT ID

NCT03947242

First Posted

May 9, 2019

Last Updated

May 13, 2019

Sponsor

Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03947242

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Anticipated)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HER2 Positive Breast Cancer

Keywords

Trastuzumab-refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pyrotinib + trastuzumab +Vinorelbine

Arm Type

Experimental

Arm Description

Pyrotinib in Combination With Trastuzumab Plus Vinorelbine

Intervention Type

Drug

Intervention Name(s)

Pyrotinib and Trastuzumab plus Vinorelbine

Intervention Description

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

Primary Outcome Measure Information:

Title

ORR

Description

Objective Response Rate

Time Frame

[Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Secondary Outcome Measure Information:

Title

Pathological Complete Response (pCR)

Description

Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated

Time Frame

Time Frame: through study completion, an average of 1 year

Title

EFS

Description

Event-free survival

Time Frame

Time Frame: Following surgery until Year 5

Title

DFS

Description

Disease-free Survival

Time Frame

Time Frame: Following surgery until Year 5

Title

DDFS

Description

Distance Disease-free Survival

Time Frame

Time Frame: Following surgery until Year 5

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiuchun Chen

Phone

18603719919

cxc701024@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

jianghua Qiao

Phone

13592581572

qiaojianghua1997@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xiuchun Chen

Organizational Affiliation

Study Principal Investigator Henan Cancer Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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