Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer

NCT ID: NCT00377780

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Myocet + docetaxel + trastuzumab

Group Type: EXPERIMENTAL

Non pegylated liposomal doxorubicin, trastuzumab, docetaxel

Intervention Type: DRUG

max. 6 courses

Interventions

Non pegylated liposomal doxorubicin, trastuzumab, docetaxel

max. 6 courses

Intervention Type: DRUG

Other Intervention Names

Myocet, herceptin, toxotere

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Laurence J.C. van Warmerdam

OTHER

Sponsor Role: lead

Responsible Party

Laurence J.C. van Warmerdam

internist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laurence J. van Warmerdam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Ziekenhuis Rijnstate

Arnhem, , Netherlands

Wilhelmina Ziekenhuis

Assen, , Netherlands

Catharina-Ziekenhuis

Eindhoven, , Netherlands

Ikazia Ziekenhuis

Rotterdam, , Netherlands

Maxima Medisch Centrum

Veldhoven, , Netherlands

VieCuri MC

Venlo, , Netherlands

Streekziekenhuis Koningin Beatrix

Winterswijk, , Netherlands

Countries

Netherlands

Other Identifiers

MYOHERTAX

Identifier Type: -

Identifier Source: org_study_id