Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer (MYOHERTAX)
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ClinicalTrials.gov Identifier: NCT00377780 |
Recruitment Status :
Terminated
(wothdrawal of sponsor)
First Posted : September 18, 2006
Last Update Posted : September 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Neoplasm Metastasis | Drug: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Myocet + docetaxel + trastuzumab
|
Drug: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
max. 6 courses
Other Name: Myocet, herceptin, toxotere |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377780
Netherlands | |
Ziekenhuis Rijnstate | |
Arnhem, Netherlands, 6800 TA | |
Wilhelmina Ziekenhuis | |
Assen, Netherlands, 9400 RA | |
Catharina-Ziekenhuis | |
Eindhoven, Netherlands, 5602 ZA | |
Ikazia Ziekenhuis | |
Rotterdam, Netherlands, 3083 AN | |
Maxima Medisch Centrum | |
Veldhoven, Netherlands, 5500 MB | |
VieCuri MC | |
Venlo, Netherlands, 5900 BX | |
Streekziekenhuis Koningin Beatrix | |
Winterswijk, Netherlands, 7100 GG |
Principal Investigator: | Laurence J. van Warmerdam, MD, PhD | Catharina Ziekenhuis Eindhoven |
Responsible Party: | Laurence J.C. van Warmerdam, internist, Catharina Ziekenhuis Eindhoven |
ClinicalTrials.gov Identifier: | NCT00377780 |
Other Study ID Numbers: |
MYOHERTAX |
First Posted: | September 18, 2006 Key Record Dates |
Last Update Posted: | September 23, 2015 |
Last Verified: | September 2015 |
Breast cancer metastatic cardiotoxicity liposomal |
doxorubicin trastuzumab docetaxel HER2/neu positive metastatic breast cancer |
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Docetaxel Doxorubicin Liposomal doxorubicin |
Trastuzumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents, Immunological |