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

Phase 2
Conditions
HER2 Gene Mutation
Breast Cancer
Registration Number
NCT03412383
Lead Sponsor
Peking Union Medical College
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
14
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

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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Progression-free survival (PFS)up to 36 months

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

Secondary Outcome Measures
NameTimeMethod
Adverse events (AEs)up to 36 months

Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)

Overall Response rates (ORR)up to 36 months

Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

Clinical Benefit rate (CBR)up to 36 months

Defined as CR+PR+stable disease (SD), assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

Time to Progression (TTP)up to 36 months

Time from first use Pyrotinib to disease progression

Quality of Life(QoL)up to 36 months

Using the EORTC quality of life questionnaire QLQ-C30

Overall survival (OS)up to 52 months

Time from first use Pyrotinib to death

Trial Locations

Locations (1)

Fei Ma

🇨🇳

Beijing, Beijing, China

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