Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
Recruiting · NCT05891561 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital - Shanghai, Shanghai Municipality, China