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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891561
• Other study ID #: RJBC-THP4
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xiaosong Chen
• Phone: +8621-64370045*602102
• Email: chenxiaosong0156[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pertuzumab
4 cycles of taxane, pertuzumab, trastuzumab

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival [OS]	Time from surgery to death from any cause	3 year
Secondary	Distant disease-free survival [DDFS]	Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause	3 year
Secondary	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