Clinical trial · Interventional
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
NCT01206881CI-TRIAL-00005157completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.
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 |
|---|---|---|---|
| pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- clinical response rate
- timeFrame
- 24 weeks
- description
- evaluation of treatment efficacy every 2.cycle
Secondary outcomes (1)
- measure
- pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen
- timeFrame
- up to 30 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * pathologically proven breast cancer * inflammatory, locally advanced breast cancer or a tumor \> 5 cm * ECOG performance status \< 2 * LVEF \> 50% measured by MUGA (HER2 positive patients) * adequate bone marrow, liver and renal function * written informed consent must be obtained Exclusion Criteria: * another malignancy within 5 years prior to study entry * concurrent treatment with an investigational agent * other disease or condition that contraindicates participation in the study * pregnant or lactating females
References
Publications (1)
- DERIVEDTuxen MK, Cold S, Tange UB, Balslev E, Nielsen DL. Phase II study of neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in locally advanced breast cancer. Acta Oncol. 2014 Oct;53(10):1440-5. doi: 10.3109/0284186X.2014.921727. Epub 2014 Jul 3. No abstract available. PMID 24991893