NCT07681323

Brief Summary

This multicenter, prospective observational cohort study aims to investigate the impact of circulating tumor DNA (ctDNA) level and key actionable gene mutation status on prognosis and treatment response in patients with advanced breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress2%
Jul 2026Jun 2029

First Submitted

Initial submission to the registry

June 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

July 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

June 26, 2026

Last Update Submit

July 20, 2026

Conditions

Advanced Breast Cancer

Keywords

ctDNAmultigene testingtreatment strategy

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    From diagnosis until death or study completion, up to 3 years

Secondary Outcomes (4)

  • Progression-Free Survival (PFS)

    From treatment initiation to progression or death, assessed every 8-12 weeks

  • Objective Response Rate (ORR)

    From treatment initiation to end of treatment, assessed every 8-12 weeks

  • Correlation of ctDNA level, gene mutations , clonality with treatment response and OS

    From diagnosis to death, up to 3 years

  • Correlation of testing timing (first-line vs. later-line) and clinical decision-making with OS

    From diagnosis to death, up to 3 years

Eligibility Criteria

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

Patients with histologically confirmed advanced breast cancer.

You may qualify if:

  • Histologically confirmed advanced breast cancer
  • Age ≥18 years
  • Expected survival \>3 months
  • Willing to undergo ctDNA testing and sign informed consent form

You may not qualify if:

  • The subject has not signed the informed consent form.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100100, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma specimens

Central Study Contacts

Fei Ma, MD

CONTACT

+8615010127581drmafei@126.com

Study Design

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

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 2, 2026

Study Start

July 8, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)