- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735966
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
Status
Completed
Conditions
Intervention / Treatment
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:
- female patients, 18 years ≤ age ≤ 75 years.
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Histologically confirmed invasive breast cancer(early stage or locally advanced):Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Life expectancy of more than 3 months
- Known hormone receptor status.
- 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.
- Signed the informed consent form prior to patient entry.
Exclusion Criteria:
- metastatic disease (Stage IV) or inflammatory breast cancer.
- 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);
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-NeoBC-HN002
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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