A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
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| ClinicalTrials.gov Identifier: NCT01038804 |
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Recruitment Status :
Completed
First Posted : December 24, 2009
Last Update Posted : September 18, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: YM155 Drug: Docetaxel | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 101 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | June 2013 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: A. YM155 plus docetaxel |
Drug: YM155
intravenous infusion Drug: Docetaxel intravenous infusion
Other Name: Taxotere |
| Active Comparator: B. docetaxel alone |
Drug: Docetaxel
intravenous infusion
Other Name: Taxotere |
- Progression free survival (PFS) [ Time Frame: At the time of progression or death or at 2 year follow up ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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): NCT01038804
Show 30 study locations
| Study Director: | Sr. Medical Director | Astellas Pharma Global Development | |
| Principal Investigator: | United Kingdom Principal Investigator | Royal Bournemouth Hospital | |
| Principal Investigator: | Poland Principal Investigator | Centrum Onkologii-Instytut im. | |
| Principal Investigator: | Ireland Principal Investigator | St. Vincent's University Hospital | |
| Principal Investigator: | Germany Principal Investigator | Luisenkrankenhaus Duesseldorf | |
| Principal Investigator: | Czech Republic Principal Investigator | Thomayer Faculty Hosptial L.G. | |
| Principal Investigator: | Belgium Principal Investigator | Institut Jules Bordet - Medical Oncology and Translational Research |
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01038804 |
| Other Study ID Numbers: |
155-CL-036 2009-012439-14 ( EudraCT Number ) |
| First Posted: | December 24, 2009 Key Record Dates |
| Last Update Posted: | September 18, 2013 |
| Last Verified: | September 2013 |
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Breast Cancer Metastatic HER2 Negative YM155 |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Docetaxel |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |