NCT03735966

Brief Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2018

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

November 5, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

December 1, 2022

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

November 5, 2018

Last Update Submit

November 28, 2022

Conditions

HER2 Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathological Complete Response (pCR)

    Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • EFS

    Following surgery until Year 5

  • DFS

    Following surgery until Year 5

  • DDFS

    Following surgery until Year 5

  • ORR

    Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Study Arms (1)

Pyrotinib plus trastuzumab and docetaxel and carboplatin

EXPERIMENTAL

Pyrotinib + trastuzumab + docetaxel+carboplatin

Drug: Pyrotinib plus trastuzumab and docetaxel and carboplatin

Interventions

Pyrotinib plus trastuzumab and docetaxel and carboplatinDRUG

pyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles

Pyrotinib plus trastuzumab and docetaxel and carboplatin

Eligibility Criteria

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

You may qualify if:

  • female patients, 18 years ≤ age ≤ 75 years.
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
  • HER2 positive (HER2+++ by IHC or FISH+)
  • Life expectancy of more than 3 months
  • Known hormone receptor status.
  • Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.
  • Signed the informed consent form prior to patient entry.

You may not qualify if:

  • metastatic disease (Stage IV) or inflammatory breast cancer.
  • Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
  • clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
  • Unable or unwilling to swallow tablets.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

pyrotinibTrastuzumabDocetaxelCarboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Zhenzhen Liu

    Study Principal Investigator Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 8, 2018

Study Start

November 20, 2018

Primary Completion

October 20, 2020

Study Completion

October 20, 2020

Last Updated

December 1, 2022

Record last verified: 2020-04

Locations

CN(1)