NCT05649475

Brief Summary

In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 24, 2023

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

November 30, 2022

Last Update Submit

February 22, 2023

Conditions

Stage I-III Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Miller-Payne grading system

    3 years

  • Residual cancer burden (RCB)

    3 years

Study Arms (1)

Patients receiving neoadjuvant therapy

Eligibility Criteria

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

Patients with stage I-III breast cancer

You may qualify if:

  • Patient is ≥ 18 years-old at the time of consent to participate this trial
  • Patients with stage I-III invasive breast cancer
  • No prior anti-cancer treatment
  • Felt to be a possible candidate for neoadjuvant therapy by their physician

You may not qualify if:

  • Known to have other aggressive malignant tumor in the past 5 years.
  • Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
  • There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
  • The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yunxiang Zhou

CONTACT

+8615868131018yxzhou@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 14, 2022

Study Start

August 31, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

February 24, 2023

Record last verified: 2022-11

Locations

CN(1)