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

NCT00377780 | Terminated Phase 2

• 1 other identifier: MYOHERTAX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer; Neoplasm Metastasis

Keywords

Breast cancer; metastatic; cardiotoxicity; liposomal; doxorubicin; trastuzumab; docetaxel; HER2/neu positive metastatic breast cancer

Outcome Measures

Primary Outcomes (4)

• Cardiotoxicity (definite or probable cardiac death)

  treatment period

• Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV

  treatment period

• Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)

  treatment period

• Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF

  treatment period

Secondary Outcomes (4)

• Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification

  treatment period

• Response rate

  treatment period

• Median time to progression

  treatment period

• Progression free survival

  treatment period

Study Arms (1)

1

EXPERIMENTAL

Myocet + docetaxel + trastuzumab

Drug: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel

Interventions

Non pegylated liposomal doxorubicin, trastuzumab, docetaxel DRUG

max. 6 courses

Also known as: Myocet, herceptin, toxotere

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with histologically documented metastatic or locally advanced metastatic HER2/neu positive breast cancer at 1st line of palliative chemotherapy.
• Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laurence J.C. van Warmerdam: lead
• Cephalon: collaborator
• Sanofi: collaborator

Study Sites (7)

Ziekenhuis Rijnstate

Arnhem, 6800 TA, Netherlands

Location

Wilhelmina Ziekenhuis

Assen, 9400 RA, Netherlands

Location

Catharina-Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5500 MB, Netherlands

Location

VieCuri MC

Venlo, 5900 BX, Netherlands

Location

Streekziekenhuis Koningin Beatrix

Winterswijk, 7100 GG, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Cardiotoxicity

Interventions

Trastuzumab; Docetaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Laurence J. van Warmerdam, MD, PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: internist

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

NL (7)