Clinical trial · Interventional
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
NCT01038804CI-TRIAL-00012173completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| YM155 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A. YM155 plus docetaxel
- interventionNames
- Drug: YM155
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- B. docetaxel alone
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- At the time of progression or death or at 2 year follow up
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.