NCT03702868

Brief Summary

Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy. The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

September 2, 2018

Last Update Submit

January 26, 2021

Conditions

Breast CancerAdjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The incidence of chemotherapy related adverse reaction

    chemotherapy related adverse reaction are assessed by CTCAE protocol

    1 years

Secondary Outcomes (1)

  • disease free survival

    5years

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

early breast cancer patients ready to receive adjuvant chemotherapy.

You may qualify if:

  • Histologically diagnosed stage I-III breast cancer;
  • Plan to receive adjuvant chemotherapy in our hospital;
  • Sign the informed consent;
  • Good compliance and willing to follow up.

You may not qualify if:

  • Those who have started receiving adjuvant chemotherapy;
  • Chemotherapy contraindications;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

fresh fecal sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhong-yu Yuan, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Zhongyu Yuan

Study Record Dates

First Submitted

September 2, 2018

First Posted

October 11, 2018

Study Start

October 10, 2018

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

CN(1)