Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.

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

Details

• Lead Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Cephalon; Sanofi
• Treatments: Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer.

• In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion.

• In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion.

• Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).

• Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if < 10% of the bone marrow was within the irradiated area.

• Age ≥ 18 years.

• Performance status 0,1, or 2.

• Life expectancy ≥ 3 months.

• Evaluable disease.

• Normal LVEF (multigated acquisition [MUGA] scan or echocardiography).

• Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10^9/l; platelets ≥ 100 x 10^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN.

• Dated and signed written informed consent.

Exclusion Criteria:

• Previous chemotherapy for metastatic disease.

• History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer.

• History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF < 50%. Uncontrolled significant heart disease, such as unstable angina.

• Poorly controlled hypertension.

• Performance status 3, 4.

• Symptomatic or progressive brain metastases.

• Active infection or other serious underlying disease.

• Concomitant participation in other clinical trials.

• Pregnant women or nursing mothers; patients of childbearing potential without effective contraception.

• Absolute medical contraindication to the use of corticosteroid premedication.

• Allergy to polysorbate 80, doxorubicin, or egg lecithin.

• NCI-CTC grade > 1 peripheral neuropathy.

• Patients not able to comply with regular medical follow-up