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

Sponsor
Peking Union Medical College (Other)
Overall Status
Unknown status
CT.gov ID
NCT03412383
Collaborator
(none)
14
Enrollment
1
Location
16.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Anticipated Study Start Date :
Feb 20, 2018
Anticipated Primary Completion Date :
Jan 25, 2019
Anticipated Study Completion Date :
Jun 25, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Adverse events (AEs) [up to 36 months]

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

  2. 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.

  3. 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.

  4. Time to Progression (TTP) [up to 36 months]

    Time from first use Pyrotinib to disease progression

  5. Quality of Life(QoL) [up to 36 months]

    Using the EORTC quality of life questionnaire QLQ-C30

  6. Overall survival (OS) [up to 52 months]

    Time from first use Pyrotinib to death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fei Ma Beijing Beijing China 100021

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fei Ma, Clinical Professor, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT03412383
Other Study ID Numbers:
  • NCC201711008
First Posted:
Jan 26, 2018
Last Update Posted:
Jan 30, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jan 30, 2018