Clinical trial · Interventional
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pertuzumab
- description
- 4 cycles of taxane, Pertuzumab, Trastuzumab
- interventionNames
- Drug: Pertuzumab
Primary outcomes (1)
- measure
- Disease free survival [DFS]
- timeFrame
- 3 year
- description
- Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause
Secondary outcomes (3)
- measure
- Overall survival [OS]
- timeFrame
- 3 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available