Short-course Trastuzumab, Pertuzumab With Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

We plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Pertuzumab

Criteria

Inclusion Criteria:

• Histologically diagnosed unilateral primary invasive breast cancer patient with pT1, pN0, and M0 disease

• HER2-positive, ie. immunohistochemistry [IHC] 3+ or IHC 2+ and fluorescence in situ hybridisation [FISH]-positive according to ASCO/CAP 2018 guidelines

• complete clinical pathological information

• Eastern Cooperative oncology Group [ECOG] 0-1

• Currently not pregnant or breast-feeding

• Fine organ function

• Have good compliance with planned treatment, understand the study process and sign a written informed consent

Exclusion Criteria:

• Bilateral or metastatic breast cancer

• Receiving neoadjuvant treatment

• Other malignancies within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer

• Severe systemic infections or other serious illnesses

• HIV infection, active hepatitis B or C infection

• Known allergy to or intolerance to a therapeutic drug or its excipients

• Prior history of chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason

• Enrollment of another investigational study within 4 weeks prior to initial administration of the investigational treatment

• Receiving live vaccine within 30 days prior to initial administration of the investigational treatment

• History of mental illness or drug abuse that may affect compliance with the trial requirements

• The researchers determine that the patients were not suitable for the study