Clinical trial · Interventional
A Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
A Multi-Centre Randomized Study Comparing Two Standard of Care Adjuvant Chemotherapy Regimens for Lower Risk HER-2 Positive Breast Cancer
- 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)
Multi-center, open-label, randomized trial of patients with low-risk, HER2+ disease, who will receive adjuvant taxane-based chemotherapy (i.e. docetaxel and cyclophosphamide with trastuzumab \[TC-H\] or weekly paclitaxel with trastuzumab \[P-H\]) at the standard approved doses, aiming to gather more information regarding cost-effectiveness, toxicity, quality of life (QoL), patient reported outcomes and clinical benefits of the two treatment strategies.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TC-H x Paclitaxel (P) + Trastuzumab(T) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TC-H Chemotherapy
- description
- Docetaxel 75 mg/m2, Cyclophosphamide 600 mg/m2 and Trastuzumab 8 mg/kg followed by 6 mg/kg Day 1 every 21 days for 4 cycles. Trastuzumab 6 mg/kg Day 1 every 21 days to complete 1 year of Trastuzumab therapy.
- interventionNames
- Drug: TC-H x Paclitaxel (P) + Trastuzumab(T)
- type
- PLACEBO_COMPARATOR
- label
- Paclitaxel(P) + Trastuzumab(T)
- description
- Paclitaxel 80 mg/m2 weekly for 12 weeks and Trastuzumab 8 mg/kg followed by 6 mg/kg Day 1 every 21 days for 4 cycles. Trastuzumab 6 mg/kg Day 1 every 21 days to complete 1 year of Trastuzumab therapy. Alternatively Trastuzumab 4 mg/kg followed by 2 mg/kg weekly to complete 1 year of treatment can be used.
- interventionNames
- Drug: TC-H x Paclitaxel (P) + Trastuzumab(T)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HER-2 positive early stage breast cancer for whom TC-H or weekly P-H is being considered. * Able to provide verbal consent. * Willing to complete study related-questionnaires Exclusion Criteria: * Unable to give informed consent or complete questionnaires
References
Publications (0)
Data not yet available