Clinical trial · Interventional
Phase II Study in Patients With Operable Breast Cancer
A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu
NCT00518583CI-TRIAL-00003029unknownPhase 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 study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
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 (Doxil) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
- timeFrame
- within 18 weeks
Secondary outcomes (5)
- measure
- Identify the complete response rate
- timeFrame
- within 18 weeks
- measure
- Identify the partial response rate
- timeFrame
- within 18 weeks
- measure
- Identify the overall response rate
- timeFrame
- within 18 weeks
- measure
- Evaluate changes in cardiac function
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Dx of clinical T1c-T3, N0-1, M0 breast cancer * Interval between diagnosis and consent of \<- 62 days * Life expectancy of 10 years * LVEF by MUGA \>= lower limit of normal for the testing facility * Negative serum pregnancy test * Adequate bone marrow, renal, liver function * Negative bone scan * HRT discontinued before study entry * Adequate contraceptive methods Exclusion Criteria: * Male breast cancer * Less than 21 years of age * Ulceration, infiltration of the skin, complete fixation or severe skin edema * N3 disease in which nodes are matted and fixed * Suspicious palpable supraclavicular nodes * CT evidence of malignant internal mammary nodes * Pregnancy or breast feeding at time of study entry * Prior therapy for breast cancer * Prior anthracycline for any malignancy * Prior breast malignancy of the contralateral breast * Prior non-breast malignancy within 5 years * Non-malignant disease that would preclude follow up * MI within 6 months, NYHA Class II or greater heart failure * Psychiatric disorders or conditions that would preclude provision of informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.