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

NCT06362096 | Not Yet Recruiting Phase 2

• 1 other identifier: pyrotinib diarrhra
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of ≥ grade 3 diarrhea

  Incidence of ≥ grade 3 diarrhea

  Up to 2 years

Study Arms (1)

ARM1

EXPERIMENTAL

Drug: Trastuzumab+pyrotinib+taxene

Interventions

Trastuzumab+pyrotinib+taxene DRUG

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

ARM1

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huihua Xiong: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiong huihua

  Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiong huihua

CONTACT

13886073988; xionghuihua@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04