Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC

NCT03876587 | Unknown Phase 2

• 1 other identifier: HR-BLTN-001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Pyrotinib Maleate; HER2 Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Ratio of CR and PR in all subjects

  from enrollment to progression or death (for any reason), assessed up to 100 months

Secondary Outcomes (4)

• PFS

  from enrollment to progression or death (for any reason),assessed up to 100 months

• DoR

  The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months

• Clinical Benefit Rate

  from enrollment to progression or death (for any reason),assessed up to 100 months

• OS

  from enrollment to death (for any reason).assessed up to 100 months

Other Outcomes (1)

• adverse event

  from enrollment to 30 days after the last dose administrate

Study Arms (1)

Pyrotinib Maleate combine with Docetaxel

EXPERIMENTAL

Pyrotinib Maleate combine with Docetaxel should be administrate to all subjects. Initial dose: Pyrotinib Maleate 400mg oral administration everyday plus Docetaxel 75mg per square of BSA every three weeks intravenous injection.

Drug: Pyrotinib Maleate combine with Docetaxel

Interventions

Pyrotinib Maleate combine with Docetaxel DRUG

Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer

Pyrotinib Maleate combine with Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
• HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
• do not chemotherapy for recurrent and metastatic lesions, but local treatment for local symptoms, such as radiotherapy for relieving bone pain, is allowed.
• if the patient is bilateral breast cancer, metastasis lesions must be HER2-positive.
• years old.
• ECOG PS 0～1.
• life expectancy is not less than 12 weeks.
• at least one measurable lesion according to RECIST 1.1.
• Endocrine therapy is allowed to relapse/metastasis disease; patients with previous adjuvant/neoadjuvant use of Taxus and trastuzumab, disease-free interval from the end of last adjuvant/neoadjuvant Taxus therapy to the progression of tumors (≥12 months), and disease-free interval from the end of last adjuvant/neoadjuvant trastuzumab to the progression of tumors (≥ 6 months).
• ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
• LVEF ≥ 50% and QTc≤480 ms.
• known hormone receptor status.
• Signed informed

You may not qualify if:

• Central nervous system metastasis.
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
• patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
• Participated in other drug clinical trials within 4 weeks before admission
• Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
• Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
• Receive other antitumour treatment at the same time
• A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
• Has suffered from any heart disease
• Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
• According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
• The patient did not recover from the toxicity of previous treatment to grade 0-1 (except hair loss).
• History of neurological or psychiatric disorders
• Along with CYP3A4 inhibitors or inducers or drugs that are using to prolong the QT interval
• Researchers believe that patients are not suitable for any other situation in this study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

• Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.

  PMID: 39024777 DERIVED

• Zheng Y, Cao WM, Shao X, Shi Y, Cai L, Chen W, Liu J, Shen P, Chen Y, Wang X, Li H, Li M, Chen Z, Wang X. Pyrotinib plus docetaxel as first-line treatment for HER2-positive metastatic breast cancer: the PANDORA phase II trial. Nat Commun. 2023 Dec 14;14(1):8314. doi: 10.1038/s41467-023-44140-y.

  PMID: 38097605 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jian Huang, chief doctor

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaojia Wang, PhD

CONTACT

86 13906500190; wxiaojia0803@163.com

Jian Huang, chief doctor

CONTACT

86 13588048995; huang_jian22@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Pyrotinib Maleate combine with Docetaxel

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 15, 2019
• Study Start: March 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: from the trial begin and for 10 years.
• Access Criteria: every one

Locations

CN (1)