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

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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; HER2 Gene Mutation
• Intervention / Treatment: Drug: Pyrotinib

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Fei Ma
      • Contact: Fei Ma, MD; Phone Number: +86-10-87787652; Email: mafei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse events (AEs)	Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)	up to 36 months
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
Time to Progression (TTP)	Time from first use Pyrotinib to disease progression	up to 36 months
Quality of Life(QoL)	Using the EORTC quality of life questionnaire QLQ-C30	up to 36 months
Overall survival (OS)	Time from first use Pyrotinib to death	up to 52 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College
• Investigators: Principal Investigator: Fei Ma, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2018
• Primary Completion (Anticipated): January 25, 2019
• Study Completion (Anticipated): June 25, 2019

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 20, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC201711008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No