A Study of Diarrhea and Intestinal Flora Changes Caused by Pyrotinib in Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT05030519
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

By measuring the intestinal flora abundance and bacterial count of patients in the early stage of using pyrotinib to clarify the relationship between diarrhea caused by pyrotinib and changes in intestinal flora in breast cancer patients, the correlation between the change of intestinal flora and the relief of diarrhea are also explored after two-cycle treatment.

Detailed Description

In recent years, small-molecule tyrosine kinase inhibitors (TKI) have achieved good results in anti-HER2 therapy and have been widely used in clinical practice, such as Breast cancer. However, such drugs can easily cause diarrhea and disorders of intestinal flora , may affect the efficacy of the drug and lead to the occurrence of other diseases.This study is to clarify the connection between the diarrhea caused by pyrotinib and the change of intestinal flora, pave the way for studying on whether the flora affects the efficacy of the drug and whether the flora should be supplemented appropriately in the future.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-09-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-13
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female breast cancer patients aged 18-75 years.
2. ECOG performance status of 0 to 1;
3. Known hormone receptor status;
4. HER2 positive breast cancer and previously reveived ≤2 anti-HER2 therapy;
5. Breast cancer patients are about to receive pyrotinib monotherapy or combined with Trastuzumab/Inetetamab and chemotherapy；
6. Patients with adequate organ function before enrollment (no blood transfusion, no white blood cell or platelet-elevating drugs used within 2 weeks before screening): 1) Blood routine:ANC≥1.5×10^9/L; PLT≥90×10^9/L; Hb≥90 g/L；2)Blood biochemistry: TBIL≤1.5×ULN;ALT and AST ≤1.5×ULN; alkaline phosphatase ≤ 2.5×ULN; BUN and Cr≤1.5×ULN；3) Cardiac color Doppler ultrasound:LVEF≥55%；4) 12-lead ECG: QTcF < 470 msec;
7. Signed the informed consent form prior to patient entry, and have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria

1. patients with Severe heart disease or discomfor;
2. Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors ;
3. Inability to swallow, intestinal obstruction, or other factors that affect the taking and absorption of the drug;
4. Allergy to pyrotinib; history of immunodeficiency, including HIV positive, active HBV/HCV, other acquired or congenital immunodeficiency disease and organ transplantation history;
5. Patients during pregnancy or lactation, patients with childbearing potential tested positive in baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial and 7 months after the last study medication;
6. patients with intestinal disease, serious concomitant diseases, or other comorbid diseases that will interfere with the planned treatment, or patients not eligible for this study judged by the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The quantity of intestinal flora from breast cancer patients' fecal microflora at different follow-up nodes	January 2021- December 2022	Fecal samples were collected from patients at each follow-up node to detect the number of bacterial species in the intestinal flora
The abundance of intestinal flora from breast cancer patients' fecal microflora at different follow-up nodes	January 2021- December 2022	Fecal samples were collected at each follow-up node to detect the richness of different bacterial species in intestinal flora

Secondary Outcome Measures

Name	Time	Method
Overall Survival（OS）	January 2021- December 2022	Time interval from randomization to death for any reason
Disease Control Rate（DCR）	January 2021- December 2022	DCR=CR+PR+SD Complete Remission(CR): All target lesions disappeared, no new lesions appeared, and tumor markers were normal, for at least 4 weeks; Partial Remission(PR): The sum of the maximum diameter of the target lesion is reduced by ≥30% and maintained for at least 4 weeks; Stable Disease(SD): The maximum diameter and reduction of the target lesion did not reach the PR, or the enlargement did not reach the PD;
Progression Free Survival (PFS)	January 2021- December 2022	Time interval from randomization to first disease progression or death for any reason
Objective Response Rate (ORR)	January 2021- December 2022	ORR=CR+PR Complete Remission(CR): All target lesions disappeared, no new lesions appeared, and tumor markers were normal, for at least 4 weeks; Partial Remission(PR): The sum of the maximum diameter of the target lesion is reduced by ≥30% and maintained for at least 4 weeks;

Trial Locations

Locations (1)

China; 🇨🇳 Zhejiang, Hangzhou, China