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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362096
• Other study ID #: pyrotinib diarrhra
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: Xiong huihua
• Phone: 13886073988
• Email: xionghuihua[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Diarrhea

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huihua Xiong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of = grade 3 diarrhea	Incidence of = grade 3 diarrhea	Up to 2 years