Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

NCT03412383 | Unknown Phase 2

• 1 other identifier: NCC201711008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Conditions

Breast Cancer; HER2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first

  up to 36 months

Secondary Outcomes (6)

• Adverse events (AEs)

  up to 36 months

• Overall Response rates (ORR)

  up to 36 months

• Clinical Benefit rate (CBR)

  up to 36 months

• Time to Progression (TTP)

  up to 36 months

• Quality of Life(QoL)

  up to 36 months

Interventions

Pyrotinib DRUG

Pyrotinib 400mg/day

Eligibility Criteria

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

You may qualify if:

• Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.
• At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.
• There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)\>70, life expectancy \> 12 weeks

You may not qualify if:

• Lack of adequate organ function as defined below within 2 weeks of registration:
• Absolute neutrophil count (ANC)\<1.5×109/L，platelet counts (PLT)\<75×109/L or hemoglobin (Hb)\<100g/L Total bilirubin (TBiL)\>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2.5×ULN（or\>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)\>2.5×ULN; serum creatinine concentration (Scr)\>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
• Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.
• Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

Fei Ma

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Yi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0.

  PMID: 39648226 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Fei Ma

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma, MD

CONTACT

+86-10-87787652; mafei@126.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: Clinical Professor

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 26, 2018
• Study Start: February 20, 2018
• Primary Completion: January 25, 2019
• Study Completion: June 25, 2019
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)