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Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer (MYOTAX)

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ClinicalTrials.gov Identifier: NCT00377559
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : October 6, 2015
Sponsor:
Collaborators:
Cephalon
Sanofi
Information provided by:
Catharina Ziekenhuis Eindhoven

Tracking Information
First Submitted Date  ICMJE September 15, 2006
First Posted Date  ICMJE September 18, 2006
Last Update Posted Date October 6, 2015
Study Start Date  ICMJE May 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • Cardiotoxicity (definite or probable cardiac death) [ Time Frame: treatment period ]
  • Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV [ Time Frame: treatment period ]
  • Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III) [ Time Frame: treatment period ]
  • Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF [ Time Frame: treatment period ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Cardiotoxicity (Definite or probable cardiac death.Signs or symptoms of CHF, NYHA class III-IV. Decline in LVEF of ≥5% to <50% with mild signs or symptoms of CHF (NYHA class <III).Decline in LVEF of ≥10% to <50% without signs or symptoms of CHF.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification [ Time Frame: treatment period ]
  • Response rate [ Time Frame: treatment period ]
  • Median time to progression [ Time Frame: treatment period ]
  • Progression free survival [ Time Frame: treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Frequency and severity of intercurrent events according to the NCI-CTC classification•; Response rate; Median time to progression; Progression free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Official Title  ICMJE Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer
Brief 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.
Detailed Description

Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease.

Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Neoplasm Metastasis
Intervention  ICMJE Drug: Non pegylated liposomal doxorubicin and docetaxel
max. 6 courses
Other Name: Myocet, Taxotere
Study Arms  ICMJE Experimental: 1.
Myocet+docetaxel
Intervention: Drug: Non pegylated liposomal doxorubicin and docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2009)
70
Original Enrollment  ICMJE
 (submitted: September 15, 2006)
60
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377559
Other Study ID Numbers  ICMJE MYOTAX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raymond J.P. Schmidt, MD, Stichting (Foundation) BO3
Study Sponsor  ICMJE Catharina Ziekenhuis Eindhoven
Collaborators  ICMJE
  • Cephalon
  • Sanofi
Investigators  ICMJE
Principal Investigator: Laurence J. van Warmerdam, MD, PhD Catharina-Ziekenhuis
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP