Clinical trial · Interventional
Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer
The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.
NCT03221881CI-TRIAL-00028687completedN/AClinicalTrials.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)
In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.
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 and docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pegylated Liposomal Doxorubicin and docetaxel
- description
- Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.
- interventionNames
- Drug: Pegylated Liposomal Doxorubicin and docetaxel
Primary outcomes (1)
- measure
- PCR rate
- timeFrame
- 12 months
- description
- pathologic complete response rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly diagnosed breast cancer; 2. Age \>18 years; 3. Eastern Cooperative Group (ECOG) performance status 0-2; 4. measurable disease (as per radiological imaging); life 5. expectancy \>12 months; 6. adequate haematologic blood profile; 7. normal liver and kidney function; 8. adequate cardiac function; 9. no metastatic disease; 10. negative pregnancy test (premenopausal women); 11. signed informed consent. Exclusion Criteria: 1. Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ; 2. Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures); 3. Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;
References
Publications (0)
Data not yet available
No reference posted for this study.