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Status unknownNCT05030519Updated Mar 2, 2022

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

An observational study in Breast Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Zhejiang Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 50 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with HER2-positive breast cancer

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugPyrotinib

    Pyrotinib 400 mg once daily(monotherapy or combined Trastuzumab/Inetetamab and chemotherapy)

    Also known as: Trastuzumab/Inetetamab and other chemotherapy

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What researchers measure

Primary outcomes

  1. The quantity of intestinal flora from breast cancer patients' fecal microflora at different follow-up nodes

    Fecal samples were collected from patients at each follow-up node to detect the number of bacterial species in the intestinal flora

    Time frame: January 2021- December 2022

  2. The abundance of intestinal flora from breast cancer patients' fecal microflora at different follow-up nodes

    Fecal samples were collected at each follow-up node to detect the richness of different bacterial species in intestinal flora

    Time frame: January 2021- December 2022

Secondary outcomes

  1. Disease Control Rate（DCR）

    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;

    Time frame: January 2021- December 2022

  2. Overall Survival（OS）

    Time interval from randomization to death for any reason

    Time frame: January 2021- December 2022

  3. Progression Free Survival (PFS)

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

    Time frame: January 2021- December 2022

  4. Objective Response Rate (ORR)

    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;

    Time frame: January 2021- December 2022

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Study locations

1 of 1 sites recruiting
  • China
    Zhejiang, Hangzhou 310022, China
    • Wenming Cao, Ph.D. · Contact · caowm@zjcc.org.cn · +86 057188122222
    • Wenming Cao, Ph.D. · Principal investigator
    Recruiting
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References and documents

Publications

  • Ross JS. Breast cancer biomarkers and HER2 testing after 10 years of anti-HER2 therapy. Drug News Perspect. 2009 Mar;22(2):93-106. doi: 10.1358/dnp.2009.22.2.1334452. PubMed 19330168 ↗
  • Freudenberg JA, Wang Q, Katsumata M, Drebin J, Nagatomo I, Greene MI. The role of HER2 in early breast cancer metastasis and the origins of resistance to HER2-targeted therapies. Exp Mol Pathol. 2009 Aug;87(1):1-11. doi: 10.1016/j.yexmp.2009.05.001. Epub 2009 May 18. PubMed 19450579 ↗
  • Ley RE, Peterson DA, Gordon JI. Ecological and evolutionary forces shaping microbial diversity in the human intestine. Cell. 2006 Feb 24;124(4):837-48. doi: 10.1016/j.cell.2006.02.017. PubMed 16497592 ↗
  • Fernandez MF, Reina-Perez I, Astorga JM, Rodriguez-Carrillo A, Plaza-Diaz J, Fontana L. Breast Cancer and Its Relationship with the Microbiota. Int J Environ Res Public Health. 2018 Aug 14;15(8):1747. doi: 10.3390/ijerph15081747. PubMed 30110974 ↗
  • Parida S, Sharma D. The power of small changes: Comprehensive analyses of microbial dysbiosis in breast cancer. Biochim Biophys Acta Rev Cancer. 2019 Apr;1871(2):392-405. doi: 10.1016/j.bbcan.2019.04.001. Epub 2019 Apr 11. PubMed 30981803 ↗
  • Yang J, Tan Q, Fu Q, Zhou Y, Hu Y, Tang S, Zhou Y, Zhang J, Qiu J, Lv Q. Gastrointestinal microbiome and breast cancer: correlations, mechanisms and potential clinical implications. Breast Cancer. 2017 Mar;24(2):220-228. doi: 10.1007/s12282-016-0734-z. Epub 2016 Oct 5. PubMed 27709424 ↗
  • Ma H, Bernstein L, Pike MC, Ursin G. Reproductive factors and breast cancer risk according to joint estrogen and progesterone receptor status: a meta-analysis of epidemiological studies. Breast Cancer Res. 2006;8(4):R43. doi: 10.1186/bcr1525. PubMed 16859501 ↗
  • Gaudet MM, Gierach GL, Carter BD, Luo J, Milne RL, Weiderpass E, Giles GG, Tamimi RM, Eliassen AH, Rosner B, Wolk A, Adami HO, Margolis KL, Gapstur SM, Garcia-Closas M, Brinton LA. Pooled Analysis of Nine Cohorts Reveals Breast Cancer Risk Factors by Tumor Molecular Subtype. Cancer Res. 2018 Oct 15;78(20):6011-6021. doi: 10.1158/0008-5472.CAN-18-0502. Epub 2018 Sep 5. PubMed 30185547 ↗
  • Wu AH, Tseng C, Vigen C, Yu Y, Cozen W, Garcia AA, Spicer D. Gut microbiome associations with breast cancer risk factors and tumor characteristics: a pilot study. Breast Cancer Res Treat. 2020 Jul;182(2):451-463. doi: 10.1007/s10549-020-05702-6. Epub 2020 May 28. PubMed 32468338 ↗
  • Goedert JJ, Jones G, Hua X, Xu X, Yu G, Flores R, Falk RT, Gail MH, Shi J, Ravel J, Feigelson HS. Investigation of the association between the fecal microbiota and breast cancer in postmenopausal women: a population-based case-control pilot study. J Natl Cancer Inst. 2015 Jun 1;107(8):djv147. doi: 10.1093/jnci/djv147. Print 2015 Aug. PubMed 26032724 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05030519
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Sep 1, 2021
Start date
Jan 18, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Mar 2, 2022

Study contacts

Wenming Cao, Ph.D.
Contact
caowm@zjcc.org.cn
+86 057188122222
Wenming Cao, Ph.D.
principal investigator · Department of Breast Medical Oncology, Zhejiang Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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