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

NCT05030519 | Unknown

• 1 other identifier: intestinal flora study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  January 2021- December 2022

• 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

  January 2021- December 2022

Secondary Outcomes (4)

• Disease Control Rate（DCR）

  January 2021- December 2022

• Overall Survival（OS）

  January 2021- December 2022

• Progression Free Survival (PFS)

  January 2021- December 2022

• Objective Response Rate (ORR)

  January 2021- December 2022

Interventions

Pyrotinib DRUG

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

Also known as: Trastuzumab/Inetetamab and other chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2-positive breast cancer

You may qualify if:

• Female breast cancer patients aged 18-75 years.
• ECOG performance status of 0 to 1;
• Known hormone receptor status;
• HER2 positive breast cancer and previously reveived ≤2 anti-HER2 therapy;
• Breast cancer patients are about to receive pyrotinib monotherapy or combined with Trastuzumab/Inetetamab and chemotherapy；
• 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;
• Signed the informed consent form prior to patient entry, and have good compliance and are willing to cooperate with follow-up.

You may not qualify if:

• patients with Severe heart disease or discomfor;
• Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors ;
• Inability to swallow, intestinal obstruction, or other factors that affect the taking and absorption of the drug;
• Allergy to pyrotinib; history of immunodeficiency, including HIV positive, active HBV/HCV, other acquired or congenital immunodeficiency disease and organ transplantation history;
• 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;
• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

China

Zhejiang, Hangzhou, 310022, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 19330168 RESULT

• 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.

  PMID: 19450579 RESULT

• 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.

  PMID: 16497592 RESULT

• 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.

  PMID: 30110974 RESULT

• 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.

  PMID: 30981803 RESULT

• 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.

  PMID: 27709424 RESULT

• 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.

  PMID: 16859501 RESULT

• 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.

  PMID: 30185547 RESULT

• 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.

  PMID: 32468338 RESULT

• 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.

  PMID: 26032724 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Identify the abundance of intestinal flora and the number of bacteria through metagenomic sequencing

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wenming Cao, Ph.D.

  Department of Breast Medical Oncology, Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenming Cao, Ph.D.

CONTACT

+86 057188122222; caowm@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: January 18, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)