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

NCT ID: NCT03876587

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-12-31

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.

Detailed Description

A multi-center, one-arm, open label design study,which is planned to enroll 79 patients with HER2-positive metastatic breast cancer receiving first-line treatment with pyrotinib and docetaxel. The main purpose of this study was to observe the efficacy and safety of first-line treatment with pyrrolidine and docetaxel for HER2-positive metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Study Design

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

Study Groups

Pyrotinib Maleate combine with Docetaxel

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.

Group Type: EXPERIMENTAL

Pyrotinib Maleate combine with Docetaxel

Intervention Type: DRUG

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

Interventions

Pyrotinib Maleate combine with Docetaxel

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 18-70 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaojia Wang(xj wang)

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Huang, chief doctor

Role: STUDY_DIRECTOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Xiaojia Wang, PhD

Role: CONTACT

wxiaojia0803@163.com

86 13906500190

Jian Huang, chief doctor

Role: CONTACT

huang_jian22@aliyun.com

86 13588048995

References

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.

Reference Type: DERIVED

PMID: 39024777 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38097605 (View on PubMed)

Other Identifiers

HR-BLTN-001

Identifier Type: -

Identifier Source: org_study_id