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The Efficacy, Cardiac Safety, and Pharmacokinetic Characteristics of Subcutaneous Pertuzumab and Trastuzumab Injection in Combination with Docetaxel and Carboplatin in Neoadjuvant Therapy for HER-2 Positive Breast Cancer: A Real-World Study

The Efficacy, Cardiac Safety, and Pharmacokinetic Characteristics of Subcutaneous Pertuzumab and Trastuzumab Injection in Combination with Docetaxel and Carboplatin in Neoadjuvant Therapy for HER-2 Positive Breast Cancer: A Real-World Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106240
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-07-21
Completion date
Unknown
Last updated
2025-08-18

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

Observation group (single-arm study):Adjust the dose and duration of chemotherapy drugs

Sponsors

Chongqing General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Female breast cancer patients aged >=18 years, who are planned to receive neoadjuvant treatment with trastuzumab emtansine injection (subcutaneous) in combination with docetaxel and carboplatin; 2.Patients with breast cancer confirmed as HER-2 positive (HER-2 immunohistochemistry staining 3+, or HER-2 immunohistochemistry staining 2+ and confirmed positive by FISH) organized by the central laboratory; 3.Conscious, without mental disorders, and with good compliance, can follow medical advice for treatment and follow-up; 4.Voluntarily join this study and have the ability to sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.HER-2 negative breast cancer patients; 2.Pregnant or planning to become pregnant and breastfeeding women; 3.Patients with allergic constitution and known or suspected allergy to drugs used in the study; 4.Patients who have participated or plan to participate in other clinical trials within the past 4 weeks; 5.Other circumstances where the researcher believes it is not appropriate to participate in this study;

Design outcomes

Primary

MeasureTime frame
Pathological complete response rate, pCR;

Secondary

MeasureTime frame
Tumor shrinkage rate;Security Analysis;Overall Response Rate;

Countries

China

Contacts

Public ContactChai Fan

Chongqing General Hospital

chaifanmail@163.com+86 23 6339 0625

Outcome results

None listed

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