Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

NCT03756064 | Unknown

• 1 other identifier: TCHP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Neoplasm, Breast; Breast Diseases

Outcome Measures

Primary Outcomes (1)

• pCR

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

  through study completion, an average of 1 year

Secondary Outcomes (4)

• EFS

  Following surgery until Year 3

• DFS

  Following surgery until Year 3

• DDFS

  Following surgery until Year 3

• ORR

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

Study Arms (2)

Experimental group

EXPERIMENTAL

Pyrotinib+Trastuzumab+Docetaxel +Carboplatin

Drug: Pyrotinib; Drug: Trastuzumab; Drug: Docetaxel; Drug: Carboplatin

Control group

PLACEBO COMPARATOR

Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin

Drug: Trastuzumab; Drug: Docetaxel; Drug: Carboplatin; Drug: Placebo Oral Tablet

Interventions

Pyrotinib DRUG

Pyrotinib: 400mg orally daily

Experimental group

Trastuzumab DRUG

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

Control group; Experimental group

Docetaxel DRUG

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

Control group; Experimental group

Carboplatin DRUG

Carboplatin: AUC=5 for a total of 6 cycles

Control group; Experimental group

Placebo Oral Tablet DRUG

Placebo Oral Tablet: 400mg orally daily

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients, 18 years ≤ age ≤ 80 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

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• Ding Y, Mo W, Xie X, Wang O, He X, Zhao S, Gu X, Liang C, Qin C, Ding K, Yang H, Ding X. Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Oncol Res Treat. 2023;46(7-8):303-311. doi: 10.1159/000531492. Epub 2023 Jun 9.

  PMID: 37302393 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

pyrotinib; Trastuzumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Ding Xiaowen, DR.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ding Xiaowen, DR.

CONTACT

+86 13588054604; dingxw@zjcc.org.cn

Ding Yuqin

CONTACT

+86 13588255651; 13588255651@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 28, 2018
• Study Start: August 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2021
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CN (1)