Breast CancerPhase 2NCT01038804
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
A Phase 2 study testing YM155 and Docetaxel in people with Breast Cancer, run by Astellas Pharma Inc at 30 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- YM155 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Dec 2009to Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
- No prior chemotherapy regimen for metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
- The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit
- The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
Who cannot join
- Hypersensitivity to docetaxel or polysorbate 80
- Neuropathy ≥ Grade 2 at the Baseline Visit
- Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
- The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Russia8 sites
State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454076
State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
Kursk, 305035
Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
Moscow, 115478
Pyatigorsk Oncology Dispensary
Pyatigorsk, 357500
Scientific-Research Institute of Oncology named after Petrov
Saint Petersburg, 189646
Saint-Petersburg State Medical University named after Pavlov
Saint Petersburg, 197022
State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
Samara, 443031
Tula Regional Dispensary
Tula, 300053
United States7 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Karmanos Cancer Institute
Detroit, Michigan, 48201
Carolina Oncology Specialists, PA
Hickory, North Carolina, 28602
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Kenmar Research Institute
Los Angeles, California, 90057
Montana Cancer Institute Foundation c/o Montana Cancer Specialists
Missoula, Montana, 59802
Bay Area Cancer Research Group
Pleasant Hill, California, 94523
Germany4 sites
Hämatologisch-onkologische Praxis
Augsburg, 86150
Frauenklinik des Universitätsklinikums Erlangen
Erlangen, 91054
Universitatsklinikum Schleswig
Kiel, 24105
Klinikum Mutterhaus der Borromaeerinnen
Trier, 54290
Belgium3 sites
Institut Jules Bordet - Medical Oncology and Translational Research
Brussels, 1000
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, 6000
Sint-Augustinus GZA Ziekenhuizen
Wilrijk, 2610
Ireland3 sites
St. Vincent's University Hospital
Dublin, 4
St. James Hospital
Dublin, 8
Department of Medical Oncology
Dublin, 9
Czechia2 sites
FN Kralovske Vinohrady
Prague, 100 34
Faculty Hospital Na Bulovce
Prague, 180 81
Poland2 sites
Centrum Onkologii-Instytut im.
Warsaw, 02-781
Wojewodzki Szpital
Wroclaw, 51-124
United Kingdom1 site
Nottingham University Hospital
Nottingham, NG5 1PB
About this study
Official title: A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.
Read the detailed description
This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.
If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.
Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.
- Conditions
- Breast Cancer
- Being tested
- YM155, Docetaxel
- Keywords
- Breast Cancer, Metastatic, HER2 Negative, YM155
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
intravenous infusion
DocetaxelDrug
Also called Taxotere
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| A. YM155 plus docetaxel | Experimental | Not described Receives: Drug: YM155; Drug: Docetaxel |
| B. docetaxel alone | Active comparator | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: At the time of progression or death or at 2 year follow up
Secondary outcomes (6)
Objective response rate (proportion of subjects with complete response or partial response)
Measured: At the time of progression or death or at 2 year follow up
Overall survival
Measured: At the time of death or at 2 year follow up
Duration of response
Measured: At the time of progression or at 2 year follow up
Clinical benefit rate
Measured: At the time of progression or death or at 2 year follow up
Time to response
Measured: At the time of response or at 2 year follow up
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Measured: Up to 30 days after last subject discontinues treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Medical Director, Study director, Astellas Pharma Global DevelopmentUnited Kingdom Principal Investigator, Principal investigator, Royal Bournemouth HospitalPoland Principal Investigator, Principal investigator, Centrum Onkologii-Instytut im.Ireland Principal Investigator, Principal investigator, St Vincent's University Hospital, IrelandGermany Principal Investigator, Principal investigator, Luisenkrankenhaus DuesseldorfCzech Republic Principal Investigator, Principal investigator, Thomayer Faculty Hosptial L.G.Belgium Principal Investigator, Principal investigator, Institut Jules Bordet - Medical Oncology and Translational Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038804
- Sponsor's protocol ID
- 155-CL-036
- Other IDs
- 2009-012439-14, 2009
- Status last verified
- Sep 2013
- First submitted
- 22 Dec 2009
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01038804
- Acronym / sponsor ID
- 155-CL-036
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Metastatic, HER2 Negative, YM155
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Dec 2009 (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.
The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.
Detailed description
This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.
If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.
Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. YM155 plus docetaxel | Experimental | Drug: YM155, Drug: Docetaxel |
| B. docetaxel alone | Active comparator | Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
- No prior chemotherapy regimen for metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
- The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit
- The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
Key exclusion criteria (4 listed)
- Hypersensitivity to docetaxel or polysorbate 80
- Neuropathy ≥ Grade 2 at the Baseline Visit
- Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
- The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
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 |
|---|---|---|
| YM155intravenous infusion | Drug | A. YM155 plus docetaxel |
| DocetaxelAlso: Taxotereintravenous infusion | Drug | A. YM155 plus docetaxel, B. docetaxel alone |
Primary outcome
Progression free survival (PFS)
Time frame: At the time of progression or death or at 2 year follow up
6 secondary outcomes
Objective response rate (proportion of subjects with complete response or partial response)
Time frame: At the time of progression or death or at 2 year follow up
Overall survival
Time frame: At the time of death or at 2 year follow up
Duration of response
Time frame: At the time of progression or at 2 year follow up
Clinical benefit rate
Time frame: At the time of progression or death or at 2 year follow up
Time to response
Time frame: At the time of response or at 2 year follow up
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: Up to 30 days after last subject discontinues treatment
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 18 Sep 2013.
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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.
Sr. Medical Director study director
Astellas Pharma Global Development
United Kingdom Principal Investigator principal investigator
Royal Bournemouth Hospital
Poland Principal Investigator principal investigator
Centrum Onkologii-Instytut im.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM155 and Docetaxel in people with Breast Cancer, run by Astellas Pharma Inc at 30 sites in 8 countries.
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 5 inclusion and 4 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Russia, United States, Germany, Belgium, Ireland and 3 more countries. 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?
Progression free survival (PFS) (time frame: At the time of progression or death or at 2 year follow up). 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 18 Sep 2013.