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The Real World Study of Initumab in the Treatment of HER2 Positive Early breast cancer

The Real World Study of Initumab in the Treatment of HER2 Positive Early breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071186
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-06
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

breast cancer

Interventions

Treatment regimen containing inizumab:No intervention measures

Sponsors

Tianjin Medical University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Female patients aged = 18 years and = 70 years; 2. HER2 positive invasive breast cancer confirmed by pathological test, HER2 positive: immunohistochemical staining (IHC) showed that HER2 was 3+and/or fluorescence in situ hybridization (FISH) positive; 3. Patients who meet the indications for neoadjuvant and/or adjuvant therapy and plan to receive treatment regimen containing inizumab; 4. Cardiac ultrasound: Left ventricular ejection fraction (LVEF) = 50%; 5. Adequate organ function; 6. Volunteer to join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Allergic constitution or known history of allergies to the ingredients of the study drug; 2. Patients with severe heart disease or discomfort who cannot receive treatment; 3. Patients with mental illness or substance abuse who cannot cooperate; 4. Pregnant or lactating female patients who are unable to take effective contraceptive measures throughout the entire trial period; 5. Any other circumstances that the researcher deems unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
tPCR;

Secondary

MeasureTime frame
invasive disease-free survival,iDFS;Adverse Event, AE ;Significant Adverse Event, SAE;Severe Adverse Event, SAE;

Countries

CHINA

Contacts

Public Contactyangshaoshi

Tianjin Medical University Second Hospital

yang631231@126.com+86 13820082620

Outcome results

None listed

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