NCT04367090

Brief Summary

The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

May 28, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

April 24, 2020

Last Update Submit

September 15, 2023

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel

    Peak Plasma Concentration (Cmax) of pyrotinib

    Approximately 2 months

  • Pharmacokinetic parameter: AUC of pyrotinib and docetaxel

    Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel

    Approximately 2 months

Secondary Outcomes (4)

  • ORR

    Approximately 17 months

  • AEs+SAEs

    Approximately 17 months

  • λz

    Approximately 6 months

  • The incidence of≥3 grade diarrhea with different treatment

    Approximately 17 months

Study Arms (1)

Pyrotinib and docetaxel plus trastuzumab

EXPERIMENTAL
Drug: Docetaxel, trastuzumabDrug: Pyrotinib

Interventions

Docetaxel, trastuzumabDRUG

Docetaxel and trastuzumab once per cycle

Pyrotinib and docetaxel plus trastuzumab
PyrotinibDRUG

Pyrotinib 400/320 mg orally daily

Pyrotinib and docetaxel plus trastuzumab

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HER2 positive recurrent or metastasis breast cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate organ function.
  • Signed, written inform consent obtained prior to any study procedure.

You may not qualify if:

  • Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
  • History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
  • Assessed by the investigator to be unable receive systemic chemotherapy.
  • History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
  • Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.

    PMID: 39024777DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelTrastuzumabpyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 29, 2020

Study Start

May 28, 2020

Primary Completion

August 10, 2022

Study Completion

May 24, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

CN(1)