Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof Dirk Elling
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Lapatinib; Liposomal doxorubicin; Paclitaxel

Criteria

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