Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Not Applicable

• Conditions: Breast Cancer; Breast Diseases; Neoplasm, Breast
• Interventions: Drug: Trastuzumab; Drug: Pyrotinib; Drug: Docetaxel; Drug: Placebo Oral Tablet; Drug: Carboplatin

• Registration Number: NCT03756064
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Status Verified: 2019-08
• Study Start: 2019-08-01
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-13
• Primary Completion: 2020-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. female patients, 18 years ≤ age ≤ 80 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 positive (HER2+++ by IHC or FISH+)
5. Known hormone receptor status.
6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
7. Signed informed consent form (ICF)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo Oral Tablet	Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
Control group	Trastuzumab	Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
Experimental group	Pyrotinib	Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Experimental group	Carboplatin	Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Experimental group	Trastuzumab	Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Experimental group	Docetaxel	Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
Control group	Carboplatin	Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
Control group	Docetaxel	Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin

Primary Outcome Measures

Name	Time	Method
pCR	through study completion, an average of 1 year	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

Secondary Outcome Measures

Name	Time	Method
DDFS	Following surgery until Year 3	Distance Disease-free Survival
ORR	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months	Objective Response Rate
EFS	Following surgery until Year 3	Event-free survival
DFS	Following surgery until Year 3	Disease-free Survival

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China