Breast CancerPhase 2MYOTAXNCT00377559
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
A Phase 2 study testing Non pegylated liposomal doxorubicin and docetaxel in people with Breast Cancer and Neoplasm Metastasis, run by Catharina Ziekenhuis Eindhoven at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Neoplasm Metastasis
- What is being tested?
- Non pegylated liposomal doxorubicin and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 10 sitesNetherlands
- Study dates
- May 2006to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Wilhelmina Ziekenhuis
Assen, 9400 RA
Catharina-Ziekenhuis
Eindhoven, 5602 ZA
Ziekenhuis Walcheren
Flushing, 4380 DD
Ikazia Ziekenhuis
Rotterdam, 3083 AN
Sint Elisabeth Ziekenhuis
Tilburg, 5000 LC
Mesos Medisch Centrum
Utrecht, 3527 CE
Maxima Medisch Centrum
Veldhoven, 5500 MB
VieCuri MC
Venlo, 5900 BX
Streekziekenhuis Koningin Beatrix
Winterswijk, 7100 GG
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Being tested
- Non pegylated liposomal doxorubicin and docetaxel
- Keywords
- Breast cancer, metastatic, cardiotoxicity, liposomal, doxorubicin, docetaxel, HER2/neu negative metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non pegylated liposomal doxorubicin and docetaxelDrug
Also called Myocet, Taxotere
max. 6 courses
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | Myocet+docetaxel Receives: Drug: Non pegylated liposomal doxorubicin and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity (definite or probable cardiac death)
Measured: treatment period
Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV
Measured: treatment period
Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)
Measured: treatment period
Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF
Measured: treatment period
Secondary outcomes (4)
Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification
Measured: treatment period
Response rate
Measured: treatment period
Median time to progression
Measured: treatment period
Progression free survival
Measured: treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, Sanofi
- Investigators
- Laurence J. van Warmerdam, MD, PhD, Principal investigator, Catharina Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377559
- Sponsor's protocol ID
- MYOTAX
- Acronym
- MYOTAX
- Status last verified
- Aug 2011
- First submitted
- 15 Sep 2006
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00377559
- Acronym / sponsor ID
- MYOTAX / MYOTAX
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Keywords
- Breast cancer, metastatic, cardiotoxicity, liposomal, doxorubicin, docetaxel, HER2/neu negative metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Cephalon, Sanofi
- Study start
- May 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Drug: Non pegylated liposomal doxorubicin and docetaxelMyocet+docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non pegylated liposomal doxorubicin and docetaxelAlso: Myocet, Taxoteremax. 6 courses | Drug | 1. |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence J. van Warmerdam, MD, PhD principal investigator
Catharina Ziekenhuis
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non pegylated liposomal doxorubicin and docetaxel in people with Breast Cancer and Neoplasm Metastasis, run by Catharina Ziekenhuis Eindhoven at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity (definite or probable cardiac death) (time frame: treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.