A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer

H

Huihua Xiong

Status and phase

Not yet enrolling
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab+pyrotinib+taxene

Study type

Interventional

Funder types

Other

Identifiers

NCT06362096
pyrotinib diarrhra

Details and patient eligibility

About

To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib

Enrollment

72 estimated patients

Sex

All

Ages

17 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged ≥ 18 years, ≤75 years
  • Her2-positive recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
  • Did not receive any systemic antitumor therapy in the advanced stage;
  • At least one measurable lesion was present according to RECIST1.1 criteria.
  • The ECOG score is 0 to 1
  • The functional major organs must be normal
  • Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up

Exclusion criteria

  • Have received any systematic antitumor therapy at the recurrence/metastasis stage;
  • Tyrosine kinase inhibitor (TKI) formulations targeting HER have been used at any stage of breast cancer
  • Patients judged by the investigators to be unsuitable for systematic chemotherapy.
  • Patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases);
  • Had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment.
  • Serious heart disease or discomfort
  • Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

72 participants in 1 patient group

ARM1
Experimental group
Treatment:
Drug: Trastuzumab+pyrotinib+taxene

Trial contacts and locations

0

Loading...

Central trial contact

Xiong huihua

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems