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

February 13, 2022 updated by: Zhejiang Cancer Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

50

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

Study Locations

  • China
    • Hangzhou
      • Zhejiang, Hangzhou, China, 310022
        • Recruiting
        • China
        • Contact:
        • Principal Investigator:
          • Wenming Cao, Ph.D.

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with HER2-positive breast cancer

Description

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 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate（DCR）
Time Frame: 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;
January 2021- December 2022
Overall Survival（OS）
Time Frame: January 2021- December 2022
Time interval from randomization to death for any reason
January 2021- December 2022
Progression Free Survival (PFS)
Time Frame: January 2021- December 2022
Time interval from randomization to first disease progression or death for any reason
January 2021- December 2022
Objective Response Rate (ORR)
Time Frame: 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;
January 2021- December 2022

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Wenming Cao, Ph.D., Department of Breast Medical Oncology, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 18, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intestinal flora study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Breast Cancer

Clinical Trials on Pyrotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe