Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer (MYOHERTAX)
This study is currently recruiting participants.
Verified August 2011 by Catharina Ziekenhuis Eindhoven
Sponsor:
Catharina Ziekenhuis Eindhoven
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
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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 May 21, 2013