AzTrials
AzTrials

Breast CancerNCT05030519

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

An observational study of Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pyrotinib
How many people
50 participants
Where
1 siteChina
Study dates
18 Jan 2021to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with HER2-positive breast cancer

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Wenming Cao, Ph.D. contact

+86 057188122222

caowm@zjcc.org.cn

China1 site, 1 recruiting

  • China

    Zhejiang, Hangzhou, 310022

    Wenming Cao, Ph.D., +86 057188122222, caowm@zjcc.org.cn

    Wenming Cao, Ph.D.

    Recruiting

Other trials in China

About this study

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.

Conditions
Breast Cancer
Being tested
Pyrotinib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PyrotinibDrug

    Also called Trastuzumab/Inetetamab and other chemotherapy

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: January 2021- December 2022

Secondary outcomes (4)

  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;

    Measured: January 2021- December 2022

  2. Overall Survival（OS）

    Time interval from randomization to death for any reason

    Measured: January 2021- December 2022

  3. Progression Free Survival (PFS)

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

    Measured: 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;

    Measured: January 2021- December 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start18 Jan 2021
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030519
Sponsor's protocol ID
intestinal flora study
Status last verified
Feb 2022
First submitted
25 Aug 2021
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenming Cao, Ph.D. (+86 057188122222, caowm@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quantity of intestinal flora from breast cancer patients' fecal microflora at different follow-up nodes (time frame: January 2021- December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030519, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in