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

NCT ID: NCT03847818

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-02-28

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.

Conditions

HER2-positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

Group Type: EXPERIMENTAL

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

Intervention Type: DRUG

Drug: Pyrotinib Pyrotinib: 400mg orally daily

Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;

Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles

Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles

Interventions

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

Drug: Pyrotinib Pyrotinib: 400mg orally daily

Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;

Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles

Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yu-Zhi Gang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Zhigang, DR.

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Shandong University

Central Contacts

Yu Zhigang, DR.

Role: CONTACT

yzg@medmail.com.cn

+86 13864182636

Other Identifiers

495573096

Identifier Type: -

Identifier Source: org_study_id