Clinical trial · Interventional
Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer
Phase I/II Trial of Primary Chemotherapy With Non-pegylated Liposomal Doxorubicin, Paclitaxel and Lapatinib in Patients With HER2-positive Early
- 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)
Open-label, multicenter phase I/II trial. Patients with HER2-positive (overexpressing or amplified), invasive breast cancer with T1c N1-2 or T2 N0-2 disease will be treated with * Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m\^2 i.v. day 1 q3 weeks), * Paclitaxel (175 mg/m\^2 i.v. day 1 q3 weeks), and * Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery) Treatment is planned for 6 cycles unless there is evidence of unacceptable toxicity, disease progression or inadequate efficacy (defined as a decrease in tumor size \<25% after 4 courses measured by ultrasound or MR-mammography), or if the patient requested to be released.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib (GW572016, Tykerb) | Drug | Lapatinib | ALIAS |
| Myocet (Non-pegylated liposomal doxorubicin (NPLD)) | Drug | Doxorubicin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LAPADO
- description
- Non-pegylated liposomal doxorubicin (NPLD; Myocet, 60 mg/m2 i.v. day 1 q3 weeks), Paclitaxel (175 mg/m2 i.v. day 1 q3 weeks), and Lapatinib (GW572016, Tykerb, 750-1500 mg/d orally daily until the day of the definitive surgery)
- interventionNames
- Drug: Myocet (Non-pegylated liposomal doxorubicin (NPLD))
- Drug: Paclitaxel
- Drug: Lapatinib (GW572016, Tykerb)
Primary outcomes (2)
- measure
- Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I)
- timeFrame
- every 3 weeks
- measure
- Evaluate the pathological response to NPLD, paclitaxel and lapatinib (phase II)
- timeFrame
- every 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer * T1c N1-2 or T2 N0-2 disease * HER2-positive tumours with 3+ intensity on immunohistochemical staining for HER2 or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) * No prior systemic treatment regimens for breast cancer * Adequate hematologic function (ANC 1500 cells/µl, platelet count 100000/µl, and hemoglobin 8g/dl). * Serum creatinine concentration \< 1.5 times the upper limit of normal (ULN) and/or creatinine clearance \>60 ml/min * Bilirubin level \< 1.5 X ULN * Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram or MUGA scan) * Karnofsky performance status 80% * Age 18 years * If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry * Written informed consent prior to admission to this study Exclusion Criteria: * Male patients * Inflammatory or bilateral breast cancer * Evidence of distant metastases * Previous systemic or local treatment for breast cancer (including surgery, radiotherapy, cytotoxic and endocrine treatments) * Past or current history of other neoplasms, except for * Curatively treated non-melanoma skin cancer * Adequately treated in situ carcinoma of the cervix * Other cancer curatively treated and with no evidence of disease for at least 5 years * Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure \>115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy * Preexisting sensoric or motor polyneuropathy Grade 2 according to NCI CTC * Serious intercurrent medical or psychiatric illness, including serious active infection * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry. * Detained persons or prisoners * Pregnant or nursing women
References
Publications (0)
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