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

NCT03847818 | Unknown

• 1 other identifier: 495573096
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Response (pCR)

  through study completion, an average of 1 year

Secondary Outcomes (4)

• 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

Study Arms (1)

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

EXPERIMENTAL

Drug: Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

Interventions

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin 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

Pyrotinib+Trastuzumab+Docetaxel+Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients, 18 years ≤ age ≤75 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Officials

• Yu Zhigang, DR.

  The Second Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhigang, DR.

CONTACT

+86 13864182636; yzg@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5/6), for a total of 4 cycles.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: February 28, 2021
• Last Updated: March 1, 2019

Record last verified: 2019-02