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

NCT ID: NCT06362096

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ARM1

Group Type: EXPERIMENTAL

Trastuzumab+pyrotinib+taxene

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huihua Xiong

OTHER

Sponsor Role: lead

Responsible Party

Huihua Xiong

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiong huihua

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Xiong huihua

Role: CONTACT

xionghuihua@hotmail.com

13886073988

Other Identifiers

pyrotinib diarrhra

Identifier Type: -

Identifier Source: org_study_id