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

Short-course Trastuzumab, Pertuzumab Combined With Taxanes in the Adjuvant Treatment of Early Human Epidermal Growth Factor Receptor 2-positive Breast Cancer: an Open-label, Single-arm 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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pertuzumab

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaosong Chen; Phone Number: +8621-64370045*602102; Email: chenxiaosong0156@hotmail.com
• Study Contact Backup: Name: Yiwei Tong; Phone Number: +8621-64370045*602107; Email: ash_yiwei@sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
      • Contact: Xiaosong Chen; Phone Number: +8621-64370045*602102
      • Contact: Yiwei Tong; Phone Number: +8621-64370045*602107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pertuzumab; 4 cycles of taxane, Pertuzumab, Trastuzumab	Drug: Pertuzumab; 4 cycles of taxane, pertuzumab, trastuzumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; adjuvant; pertuzumab; her2
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: RJBC-THP4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No