Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer

Not Applicable

• Conditions: HER2-positive Breast Cancer
• Interventions: Drug: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

• Registration Number: NCT03847818
• Lead Sponsor: Shandong University

Brief Summary

This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy 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 (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) 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

• Status Verified: 2019-02
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Last Update Submitted: 2019-02-28
• Study Start: 2019-03-01
• Last Update Posted: 2019-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 268

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）
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)

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyrotinib+Trastuzumab+Docetaxel+Carboplatin	Pyrotinib+Trastuzumab+Docetaxel+Carboplatin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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