Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.

November 28, 2022 updated by: Henan Cancer Hospital

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer : a Single-arm,Ahead , Open-label Study

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Study Overview

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 Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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. Life expectancy of more than 3 months
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyrotinib plus trastuzumab and docetaxel and carboplatin
Pyrotinib + trastuzumab + docetaxel+carboplatin
pyrotinib: 320mg orally daily,6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ,AUC 6 iv 3-weekly for a total of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR)
Time Frame: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS
Time Frame: Following surgery until Year 5
Event-free survival
Following surgery until Year 5
DFS
Time Frame: Following surgery until Year 5
Disease-free Survival
Following surgery until Year 5
DDFS
Time Frame: Following surgery until Year 5
Distance Disease-free Survival
Following surgery until Year 5
ORR
Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Objective Response Rate
Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zhenzhen Liu, Study Principal Investigator Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

October 20, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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