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A cohort study using ctDNA for HER2-positive breast cancer with sustained therapeutic effects from anti-HER2 treatment

Personalized Detection of ctDNA for Patients with HER2 Positive Metastatic Breast Cancer who Achieved Durable Response by Anti-HER2 Treatment - HER2CR

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055735
Enrollment
50
Registered
2024-10-03
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive metastatic breast cancer

Interventions

None listed

Sponsors

Nagoya City University
Lead Sponsor
Natera
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Histologically invasive breast cancer. Diagnosed with unresectable HER2-positive breast cancer Drug therapy, including anti-HER2 therapy, was initiated between January 1, 2000, and December 31, 2021. Maintained partial or complete response for more than two years with drug therapy, including anti-HER2 therapy. Women aged 20 years or older.

Exclusion criteria

Exclusion criteria: Patients deemed unsuitable as research subjects by the physicians' judgment, such as those possibly receiving inappropriate treatment.

Design outcomes

Primary

MeasureTime frame
The positivity rate of ctDNA

Secondary

MeasureTime frame
Association between ctDNA status and treatment response Comparison between ctDNA-negative and ctDNA-positive groups

Countries

Japan

Contacts

Public ContactKazuki Nozawa

Nagoya City University Department of Advanced Clinical Research and Development

kazuki.nozawa7@gmail.com0528538628

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026