Trial | NCT00377780  Report issue

Title

Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer
Phase II Multicentre Open Label Study Evaluating the Efficacy and Safety of Liposomal Doxorubicin, Trastuzumab, Docetaxel as First-line Treatment of Patients With HER2 Positive Metastatic Breast Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    60
This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu positive breast cancer.
Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu positive breast cancer not yet treated with chemotherapy for metastatic disease.

Myocet and Taxotere will be given for a maximum of 6 cycles, Herceptin treatment for 1 year is recommended.

Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.
Study Started
Aug 31
2006
Primary Completion
Aug 31
2015
Study Completion
Aug 31
2015
Last Update
Sep 23
2015
Estimate

Drug Non pegylated liposomal doxorubicin, trastuzumab, docetaxel

max. 6 courses

  • Other names: Myocet, herceptin, toxotere

1 Experimental

Myocet + docetaxel + trastuzumab

Criteria 

Inclusion Criteria:

Women with histologically documented metastatic or locally advanced metastatic HER2/neu positive breast cancer at 1st line of palliative chemotherapy.
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 ≤ 240 mg/m2 of doxorubicin or 450 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
No Results Posted