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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Catharina Ziekenhuis Eindhoven.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cephalon
Sanofi
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00377780
First received: September 14, 2006
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Neoplasm Metastasis
Drug: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • Cardiotoxicity (definite or probable cardiac death) [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]
  • Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification [ Time Frame: treatment period ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: treatment period ] [ Designated as safety issue: No ]
  • Median time to progression [ Time Frame: treatment period ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Myocet + docetaxel + trastuzumab
Drug: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
max. 6 courses
Other Name: Myocet, herceptin, toxotere

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377780

Contacts
Contact: Laurence J. van Warmerdam, MD, PhD 040-2397240 rsc@rsconsultancy.nl
Contact: Raymond J. Schmidt, MD 0575-441001 rsc@rsconsultancy.nl

Locations
Netherlands
Ziekenhuis Rijnstate Recruiting
Arnhem, Netherlands, 6800 TA
Principal Investigator: Joep Douma, MD PhD         
Wilhelmina Ziekenhuis Recruiting
Assen, Netherlands, 9400 RA
Principal Investigator: Peter Nieboer, MD         
Catharina-Ziekenhuis Recruiting
Eindhoven, Netherlands, 5602 ZA
Principal Investigator: Laurence J. van Warmerdam, MD, PhD         
Ikazia Ziekenhuis Recruiting
Rotterdam, Netherlands, 3083 AN
Principal Investigator: Felix E. de Jongh, MD         
Maxima Medisch Centrum Recruiting
Veldhoven, Netherlands, 5500 MB
Principal Investigator: G. Vreugdenhil, MD, PhD         
VieCuri MC Recruiting
Venlo, Netherlands, 5900 BX
Principal Investigator: Y. van der Wouw, MD         
Streekziekenhuis Koningin Beatrix Recruiting
Winterswijk, Netherlands, 7100 GG
Principal Investigator: P. P. Schiphorst, MD         
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Cephalon
Sanofi
Investigators
Principal Investigator: Laurence J. van Warmerdam, MD, PhD Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: Raymond J.P. Schmidt, MD, Stichting (Foundation) BO3
ClinicalTrials.gov Identifier: NCT00377780     History of Changes
Other Study ID Numbers: MYOHERTAX
Study First Received: September 14, 2006
Last Updated: August 10, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Breast cancer
metastatic
cardiotoxicity
liposomal
doxorubicin
trastuzumab
docetaxel
HER2/neu positive metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Doxorubicin
Docetaxel
Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014