Back to resultsNeoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
Primary Purpose
Breast Cancer, Neoplasm, Breast, Breast Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Trastuzumab
Docetaxel
Carboplatin
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- female patients, 18 years ≤ age ≤ 80 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- HER2 positive (HER2+++ by IHC or FISH+)
- Known hormone receptor status.
- Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
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.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
Outcomes
Primary Outcome Measures
pCR
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Secondary Outcome Measures
EFS
Event-free survival
DFS
Disease-free Survival
DDFS
Distance Disease-free Survival
ORR
Objective Response Rate
Full Information
NCT ID
NCT03756064
First Posted
November 21, 2018
Last Updated
August 8, 2019
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03756064
Brief Title
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
Detailed Description
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.
It is proposed that 100 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic therapy.
The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoplasm, Breast, Breast Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.
Placebo Comparator: Placebo Oral Tablet (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Pyrotinib: 400mg orally daily
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel: 75mg/m2 for a total of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin: AUC=5 for a total of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo Oral Tablet: 400mg orally daily
Primary Outcome Measure Information:
Title
pCR
Description
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
EFS
Description
Event-free survival
Time Frame
Following surgery until Year 3
Title
DFS
Description
Disease-free Survival
Time Frame
Following surgery until Year 3
Title
DDFS
Description
Distance Disease-free Survival
Time Frame
Following surgery until Year 3
Title
ORR
Description
Objective Response Rate
Time Frame
Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients, 18 years ≤ age ≤ 80 years；
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
Histologically confirmed invasive breast cancer（early stage or locally advanced）
HER2 positive (HER2+++ by IHC or FISH+)
Known hormone receptor status.
Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
Signed informed consent form (ICF)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Xiaowen, DR.
Phone
+86 13588054604
Email
dingxw@zjcc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ding Yuqin
Phone
+86 13588255651
Email
13588255651@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Xiaowen, DR.
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaowen ding, Dr.
Phone
+8613588054604
Email
dingxw@zjcc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
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