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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Pertuzumab

• Registration Number: NCT05891561
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-21
• Study First Submitted QC: 2023-06-04
• Study First Posted: 2023-06-07
• Study Start: 2023-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pertuzumab	Pertuzumab	4 cycles of taxane, Pertuzumab, Trastuzumab

Primary Outcome Measures

Name	Time	Method
Disease free survival [DFS]	3 year	Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival [OS]	3 year	Time from surgery to death from any cause
Distant disease-free survival [DDFS]	3 year	Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 year	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China