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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaosong Chen
chenxiaosong0156@hotmail.com
+8621-64370045*602102
Backup
Yiwei Tong
ash_yiwei@sjtu.edu.cn
+8621-64370045*602107
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: Pertuzumab
4 cycles of taxane, Pertuzumab, Trastuzumab
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov