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The treatment mode and strategy of HER2- positive and HER2-low advanced breast cancer: an observational study

The treatment mode and strategy of HER2- positive and HER2-low advanced breast cancer: an observational study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093828
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-05-07
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

HER2 positive or HER-2 low expression advanced breast cancer

Interventions

Anti-HER-2 targeted therapy GROUP:NA

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age over 18 years old; 2.inoperable or metastatic breast cancer confirmed by pathology or imaging; 3.Pathological diagnosis of HER-2 positivity (definition: HER-2 IHC 2+and FISH+or IHC 3+) or HER-2 low expression (definition: HER2 IHC 2+/ISH - and IHC 1+); 4.at least one assessable target lesion; 5.anti-tumor therapy including anti-HER-2 targeted therapy; 6.Voluntarily participate in this study and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1.Unclear record of treatment drugs; 2.refuses to accept follow-up or explicitly refuses to sign an informed consent form;

Design outcomes

Primary

MeasureTime frame
Objective relief rate, ORR;

Secondary

MeasureTime frame
Survival time without progression, PFS;Overall Survival, OS;Disease control rate, DCR;Adverse reaction rate;

Countries

China

Contacts

Public ContactBei Xu

Zhongshan Hospital, Fudan University

xu.bei2@zs-hospital.sh.cn+86 21 52303355

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026