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Demonstration Project on the Use of Trastuzumab for Injection in HER2-Positive Breast Cancer

Demonstration Project on the Use of Trastuzumab for Injection in HER2-Positive Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121381
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Breast cancer

Interventions

Retrospective cohort:None
Prospective cohort:None

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female individuals aged 18 or above. 2. Histological or cytological diagnosis of breast adenocarcinoma. 3. Based on the formalin-fixed paraffin-embedded tissue blocks collected from primary tumors or metastatic lesions, and according to the test results of FISH magnification >=2.0 or IHC score 3+, it is confirmed to be HER2 positive. It can also confirm the status of the Estrogen receptor/progesterone receptor (ER/PgR). 4. Measurable disease (with at least one measurable target lesion evaluated by centralized imaging reading).

Exclusion criteria

Exclusion criteria: 1. Retrospective studies with incomplete medical records. 2. Prospective studies where patients were unable to accept or complete follow-up

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Overall survival;Objective response rate;Adverse drug reaction rate;Serious adverse drug reaction rate;

Secondary

MeasureTime frame
Disease control rate;Disease-free survival;

Countries

China

Contacts

Public ContactLi Xiaoyu

Zhongshan Hospital Fudan University

li.xiaoyu@zs-hospital.sh.cn+86 158 0039 6535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026