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Clinical Study on Preoperative Treatment of Early or Locally Advanced HER-2 Positive breast cancer with Trastuzumab combined with Pertuzumab, Paclitaxel-albumin and Carboplatin

Clinical Study on Preoperative Treatment of Early or Locally Advanced HER-2 Positive breast cancer with Trastuzumab combined with Pertuzumab, Paclitaxel-albumin and Carboplatin

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104942
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Breast Cancer

Interventions

Experimental group:Trastuzumab combined with Pertuzumab, Paclitaxel-albumin, and Carboplatin

Sponsors

The 2nd Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female initial treatment patients aged>=18 years and =55%. 4) 12 lead electrocardiogram The QT interval (QTcF) corrected by the Fridericia method is less than 470 milliseconds. 6. The researcher determines that they can comply with the research protocol; 7. Understand and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Inflammatory breast cancer; 3. Have received previous anti-tumor treatment or radiation therapy for any malignant tumor; 4. Have a history of other malignant tumors within the past 5 years prior to signing the informed consent form; 5. Have received or are receiving targeted, immunotherapy or traditional Chinese patent medicines and simple preparations with clear anti-tumor indications for the disease; 6. The patient has undergone major surgical procedures within 4 weeks prior to enrollment and has not fully recovered from such surgical procedures; 7. Used any clinical trial drug within 4 weeks prior to enrollment; 8. Those who are HIV positive, anti HCV positive, HCV RNA positive and syphilis antibody positive before enrollment, hepatitis B surface antigen positive and HBV DNA quantitative test are determined as positive by the researcher according to local standards; 9. Prior to enrollment, there was severe heart disease or discomfort; 10. Allergic to any investigational drug or its components or excipients, or allergic to benzyl alcohol; 11. Breastfeeding women; 12. Bilateral breast cancer; 13. Diabetic patients with peripheral neuropathy; 14. According to the researcher's judgment, the subject may have complications that may interfere with the research plan or other situations that are not suitable for participating in clinical trials.

Design outcomes

Primary

MeasureTime frame
total pathological complete response (tpCR);

Secondary

MeasureTime frame
event-free survival;objective response rate;breast pathological complete response;safety;

Countries

China

Contacts

Public ContactGuo Baoliang

The 2nd Affiliated Hospital of Harbin Medical University

baoliangguo2020@hrbmu.edu.cn+86 139 3660 8299

Outcome results

None listed

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