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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00377780
Other study ID # MYOHERTAX
Secondary ID
Status Terminated
Phase Phase 2
First received September 14, 2006
Last updated September 22, 2015
Start date August 2006
Est. completion date August 2015

Study information

Verified date September 2015
Source Catharina Ziekenhuis Eindhoven
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
max. 6 courses

Locations

Country Name City State
Netherlands 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

Sponsors (3)

Lead Sponsor Collaborator
Laurence J.C. van Warmerdam Cephalon, Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiotoxicity (definite or probable cardiac death) treatment period Yes
Primary Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV treatment period Yes
Primary Decline in left ventricular ejection fraction (LVEF) of = 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III) treatment period Yes
Primary Decline in LVEF of = 10% to < 50% without signs or symptoms of CHF treatment period Yes
Secondary Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification treatment period Yes
Secondary Response rate treatment period No
Secondary Median time to progression treatment period No
Secondary Progression free survival treatment period No
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