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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412383
• Other study ID #: NCC201711008
• Status: Recruiting
• Phase: Phase 2
• First received: January 14, 2018
• Last updated: January 28, 2018
• Start date: February 20, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: January 2018
• Source: Peking Union Medical College
• Contact: Fei Ma, MD
• Phone: +86-10-87787652
• Email: mafei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: June 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2 Gene Mutation

Intervention

Drug:
• Pyrotinib
Pyrotinib 400mg/day

Locations

Country	Name	City	State
China	Fei Ma	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events (AEs)	Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)	up to 36 months
Secondary	Overall Response rates (ORR)	Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.	up to 36 months
Secondary	Clinical Benefit rate (CBR)	Defined as CR+PR+stable disease (SD), assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.	up to 36 months
Secondary	Time to Progression (TTP)	Time from first use Pyrotinib to disease progression	up to 36 months
Secondary	Quality of Life(QoL)	Using the EORTC quality of life questionnaire QLQ-C30	up to 36 months
Secondary	Overall survival (OS)	Time from first use Pyrotinib to death	up to 52 months