Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Zhejiang Cancer Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Breast Cancer Neoplasm, Breast Breast Diseases

Interventions

PyrotinibDRUG

Pyrotinib: 400mg orally daily

TrastuzumabDRUG

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

DocetaxelDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) 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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

pCR

Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.

Time frame: through study completion, an average of 1 year

Secondary Outcomes

EFS

Event-free survival

Time frame: Following surgery until Year 3

DFS

Disease-free Survival

Time frame: Following surgery until Year 3

DDFS

Distance Disease-free Survival

Time frame: Following surgery until Year 3

ORR

Objective Response Rate

Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Central Contacts

Ding Xiaowen, DR.

CONTACT

+86 13588054604 dingxw@zjcc.org.cn

Ding Yuqin

CONTACT

+86 13588255651 13588255651@163.com

Data from ClinicalTrials.gov

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