Recruiting

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

The investigators 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.

ClinicalTrials.gov IDNCT05891561
PhasePHASE2
Enrollment120
SponsorShanghai Jiao Tong University School of Medicine
Age18 Years – 75 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Breast Cancer

About this study

The investigators 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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.