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

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05030519
Collaborator
(none)
50
1
23.4
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Study of Diarrhea and Intestinal Flora Changes Caused by Pyrotinib in Breast Cancer
Actual Study Start Date :
Jan 18, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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;

  2. Overall Survival(OS) [January 2021- December 2022]

    Time interval from randomization to death for any reason

  3. Progression Free Survival (PFS) [January 2021- December 2022]

    Time interval from randomization to first disease progression or death for any reason

  4. 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;

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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≥1.5×109/L; PLT≥90×109/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;

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Zhejiang Hangzhou China 310022

Sponsors and Collaborators

  • Zhejiang Cancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05030519
Other Study ID Numbers:
  • intestinal flora study
First Posted:
Sep 1, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022