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

NCT05891561 | Recruiting Phase 2

• 1 other identifier: RJBC-THP4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; pertuzumab; her2; adjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival [OS]

  3 year

• Distant disease-free survival [DDFS]

  3 year

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3 year

Study Arms (1)

Pertuzumab

EXPERIMENTAL

4 cycles of taxane, Pertuzumab, Trastuzumab

Drug: Pertuzumab

Interventions

Pertuzumab DRUG

4 cycles of taxane, pertuzumab, trastuzumab

Pertuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaosong Chen

CONTACT

+8621-64370045*602102; chenxiaosong0156@hotmail.com

Yiwei Tong

CONTACT

+8621-64370045*602107; ash_yiwei@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 7, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)