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

April 8, 2024 updated by: Huihua Xiong

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged ≥ 18 years, ≤75 years
  2. 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.
  3. Did not receive any systemic antitumor therapy in the advanced stage;
  4. At least one measurable lesion was present according to RECIST1.1 criteria.
  5. The ECOG score is 0 to 1
  6. The functional major organs must be normal
  7. Volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM1
Drug: Trastuzumab+pyrotinib+taxene
Trastuzumab (first cycle 8mg/Kg, subsequent 6mg/Kg, iv, q3w) Pyrrotinib * po, qd, q3w The first cycle 240mg+ montmorillonite powder, the second cycle 320mg+ montmorillonite powder prevention Subsequent cycle 400mg+* montmorillonite powder used when necessary taxenes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ≥ grade 3 diarrhea
Time Frame: Up to 2 years
Incidence of ≥ grade 3 diarrhea
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huihua Xiong

Investigators

  • Principal Investigator: Xiong huihua, Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pyrotinib diarrhra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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