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Real-World Study on the Efficacy and Safety of Inetetamab Combined with Chemotherapy for HER2-Positive Advanced Breast Cancer

Real-World Study on the Efficacy and Safety of Inetetamab Combined with Chemotherapy for HER2-Positive Advanced Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129680
Enrollment
Unknown
Registered
2026-08-07
Start date
2025-05-16
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

HER2-positive breast cancer

Interventions

Inetetamab treatment group:None

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Only participants who meet all of the following inclusion criteria will be eligible for enrollment in this trial: 1. Age 18 to 80 years; 2.Histologically and/or cytologically confirmed diagnosis of advanced breast cancer; 3.Tumor with confirmed HER2 overexpression or gene amplification in the primary and/or metastatic site (immunohistochemistry [IHC] 3+ or IHC 2+ with fluorescence in situ hybridization [FISH] confirmation); 4.Presence of at least one measurable tumor lesion (according to RECIST 1.1); 5.Complete clinical data relevant to key study endpoints; 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 7.Life expectancy greater than 3 months.

Exclusion criteria

Exclusion criteria: 1.Participants who meet any of the following criteria will be ineligible for enrollment in this trial: Incomplete or missing medical records; 2.Symptomatic central nervous system metastasis; 3.Pregnant or breastfeeding women; 4.Presence of other malignancies within the past 5 years (except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or controlled basal cell carcinoma of the skin); 5.Any other reason that the investigator deems the participant unsuitable for participation in this study;

Design outcomes

Primary

MeasureTime frame
Progress-Free Survival;

Secondary

MeasureTime frame
Overall Response Rate;Disease Control Rate;Overall Survival;Adverse Events;

Countries

China

Contacts

Public ContactChen Wang

Tianjin Medical University Cancer Institute and Hospital

oncology@vip.qq.com+86 22 23340123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026