Breast Cancer
Conditions
Keywords
breast cancer, pertuzumab, her2, adjuvant
Brief 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.
Interventions
DRUGPertuzumab
4 cycles of taxane, pertuzumab, trastuzumab
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival [DFS] | 3 year | Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival [OS] | 3 year | Time from surgery to death from any cause |
| Distant disease-free survival [DDFS] | 3 year | Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactXiaosong Chen
Backup ContactYiwei Tong
Outcome results
None listed