Short-course treatment for early HER2-positive breast cancer
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
This study is testing a shorter treatment plan with two medications for early HER2-positive breast cancer to see if it works just as well as the usual year-long treatment but with fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation, trastuzumab, pertuzumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05891561 on ClinicalTrials.gov |
What this trial studies
This phase II, open-label, single-arm clinical study investigates the effectiveness of a short-course regimen combining trastuzumab and pertuzumab with taxanes for patients with early HER2-positive breast cancer. The goal is to determine if four courses of this dual HER2 blockade can achieve similar outcomes to the standard one-year trastuzumab monotherapy while minimizing adverse effects. Participants will receive the treatment and be monitored for their response and side effects.
Who should consider this trial
Good fit: Ideal candidates include patients with unilateral primary invasive HER2-positive breast cancer who meet specific clinical criteria.
Not a fit: Patients with bilateral or metastatic breast cancer, or those who have received prior treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less toxic treatment option for patients with early HER2-positive breast cancer.
How similar studies have performed: While similar approaches have been explored, this specific combination and short-course regimen is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaosong Chen
- Email: chenxiaosong0156@hotmail.com
- Phone: +8621-64370045*602102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.