Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05891561
- Run by
- Shanghai Jiao Tong University School of Medicine
- People needed
- 120
- Starts
- 2023-11-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-11-27
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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