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

NCT03947242 | Unknown

• 1 other identifier: HR-NeoBC-HN003
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HER2 Positive Breast Cancer

Keywords

Trastuzumab-refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pathological Complete Response (pCR)

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

• EFS

  Time Frame: Following surgery until Year 5

• DFS

  Time Frame: Following surgery until Year 5

• DDFS

  Time Frame: Following surgery until Year 5

Study Arms (1)

Pyrotinib + trastuzumab +Vinorelbine

EXPERIMENTAL

Pyrotinib in Combination With Trastuzumab Plus Vinorelbine

Drug: Pyrotinib and Trastuzumab plus Vinorelbine

Interventions

Pyrotinib and Trastuzumab plus Vinorelbine DRUG

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

Pyrotinib + trastuzumab +Vinorelbine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Interventions

pyrotinib; Trastuzumab; Vinorelbine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• xiuchun Chen

  Study Principal Investigator Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiuchun Chen

CONTACT

18603719919; cxc701024@163.com

jianghua Qiao

CONTACT

13592581572; qiaojianghua1997@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 30, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05