Metastatic Breast CancerPhase 2MyoPacNCT00691912
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin
A Phase 2 study testing liposomal Doxorubicin and Myocet / Paclitaxel in people with Metastatic Breast Cancer, run by Claudia Lorenz-Schlüter at 1 site in Germany.
Trial summary
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- liposomal Doxorubicin and Myocet / Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Dec 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women >/= 18 years with histologically proven metastatic breast cancer
- No prior chemotherapy in the advanced situation
- ECOG </= 2
- Adequate bone marrow reserve
- left ventricular ejection fraction (LVEF) >/= 50, measured within 4 weeks before study treatment
- Existence of written informed consent
Who cannot join
- Previous high dose therapy with stem cell support
- Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone
- Concomitant hormon- or chemotherapy or radiation therapy
- Her2/neu overexpression
- pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik
Magdeburg, Saxony-Anhalt, 39108
About this study
Official title: Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.
Read the detailed description
Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.
Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.
Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.
Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- liposomal Doxorubicin, Myocet / Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal DoxorubicinDrug
Also called Myocet
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
Myocet / PaclitaxelDrug
20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d
| Study group | Role | What they receive |
|---|---|---|
| Myocet/Paclitaxel | Experimental | 20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d Receives: Drug: liposomal Doxorubicin; Drug: Myocet / Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival assessed by imaging procedures
Measured: after 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (2)
toxicity, quality of life
Measured: every 3 weeks
response rate, overall survival
Measured: 28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Study was stopped due because recrutation.was much slower as anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Lorenz-Schlüter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Lorenz-Schlüter, University of Magdeburg
- Investigators
- Joachim Bischoff, Dr. med., Principal investigator, Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691912
- Sponsor's protocol ID
- 4102000
- Acronym
- MyoPac
- Status last verified
- Sep 2014
- First submitted
- 4 Jun 2008
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Dose Frequency 1st-line Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin (Myocet®)
- ClinicalTrials.gov ID
- NCT00691912
- Acronym / sponsor ID
- MyoPac / 4102000
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due because recrutation.was much slower as anticipated.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Claudia Lorenz-SchlüterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 2008 (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.
Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.
Detailed description
Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.
Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.
Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.
Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocet/Paclitaxel | Experimental | Drug: liposomal Doxorubicin, Drug: Myocet / Paclitaxel20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women >/= 18 years with histologically proven metastatic breast cancer
- No prior chemotherapy in the advanced situation
- ECOG </= 2
- Adequate bone marrow reserve
- left ventricular ejection fraction (LVEF) >/= 50, measured within 4 weeks before study treatment
Key exclusion criteria (5 listed)
- Previous high dose therapy with stem cell support
- Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone
- Concomitant hormon- or chemotherapy or radiation therapy
- Her2/neu overexpression
- pregnancy or breast feeding
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 |
|---|---|---|
| liposomal DoxorubicinAlso: Myocet20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d | Drug | Myocet/Paclitaxel |
| Myocet / Paclitaxel20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d | Drug | Myocet/Paclitaxel |
Primary outcome
progression free survival assessed by imaging procedures
Time frame: after 6 weeks, 12 weeks, 18 weeks
2 secondary outcomes
toxicity, quality of life
Time frame: every 3 weeks
response rate, overall survival
Time frame: 28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years.
Results and safety
The study was stopped early (reason given: Study was stopped due because recrutation.was much slower as anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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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.
Joachim Bischoff, Dr. med. principal investigator
Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal Doxorubicin and Myocet / Paclitaxel in people with Metastatic Breast Cancer, run by Claudia Lorenz-Schlüter at 1 site in Germany.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 was stopped early (reason given: Study was stopped due because recrutation.was much slower as anticipated.). Results are not available in the source record.
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?
progression free survival assessed by imaging procedures (time frame: after 6 weeks, 12 weeks, 18 weeks). 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 3 Sep 2014.