Adenocarcinoma of the breast that is HER2 negative. MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: YM155
Product Code: YM155
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 781661-94-7
Current Sponsor code: YM155
Other descriptive name: N/A
Concentration unit: m
Sponsors
Astellas Pharma Global Development, Inc. (APGD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject is eligible for the study if all of the following apply: 1. The subject prior to any study-related procedures (including withdrawal of prohibited medicines, if applicable) has provided Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)- approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites). 2. The subject is male or female and aged 18 years or older at the Baseline Visit with metastatic breast cancer. 3. The subject has histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative defined as one of the following: o Negative fluorescence in-situ hybridization (FISH). o 0 or 1+ immunohistochemistry (IHC). o IHC 2+ with negative FISH. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, rogesterone receptor negative and HER2 negative) are eligible. 4. The subject has received no prior chemotherapy regimen for metastatic breast cancer. o Prior treatment with a cytotoxic therapy (other than docetaxel) is allowed if administered in the neoadjuvant or adjuvant setting >3 weeks prior to the Baseline Visit, with all side effects of using prior cytotoxic therapy resolved or back to baseline (with the exception of weight loss or gain, anorexia, alopecia or fatigue). o Prior treatment with docetaxel is allowed if administered in the neoadjuvant or adjuvant setting, and the subject has no recurrent disease within 12 months after completing treatment, with all side effects of prior docetaxel use resolved or back to baseline (with the exception of weight loss or gain, anorexia, alopecia or fatigue). o Prior treatment with a kinase inhibitor, biologic therapy, vaccine, or investigational treatment other than cytotoxic therapy or procedure for breast cancer is allowed if administered in the neoadjuvant, adjuvant or metastatic setting = 4 weeks prior to the Baseline Visit. o Prior treatment with hormonal therapy in the neoadjuvant, adjuvant or metastatic setting is allowed if administered = 2 weeks prior to the Baseline Visit. o Prior treatment with bevacizumab is allowed if administered in the neoadjuvant or adjuvant setting >4 weeks prior to the Baseline Visit. 5. Prior palliative radiation therapy is allowed if treatment was completed = 2 weeks prior to the Baseline Visit with side effects from radiation resolved. 6. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status = 1 at the Baseline Visit. 7. The subject has at least one measurable lesion by RECIST (Version 1.1). o If the selected lesion(s) received prior radiation and/or loco-regional therapy, there must be evidence of disease progression since the last radiation or locoregional therapy. 8. If the subject has a previous history of non-breast cancer malignancy, the subject must meet the following criteria for a cancer survivor: o Subject having a previous history of a non-invasive carcinoma is eligible if in the opinion of the Investigator, he/she has successful curative treatment anytime prior to enrollment. o For all other malignacies, the subject has undergone potentially curative therapy and the subject has been considered disease free for at least 5 years. 9. The subject’s life expectancy is estimated to be > 12 weeks at the Baseline
Exclusion criteria
Exclusion criteria: A subject will be excluded from participation if any of the following apply: 1. The subject has hypersensitivity to docetaxel or polysorbate 80. 2. The subject has had a major surgical procedure, substantial open biopsy, or significant traumatic injury within 28 days prior to the Baseline Visit or anticipation of need for major surgical procedure during the course of the study. 3. The subject has neuropathy = Grade 2 at the Baseline Visit. 4. The subject has inadequate marrow, hepatic and/or renal function at the Baseline Visit defined as: o Serum creatinine = 1.5 x ULN or calculated serum creatinine clearance 2.5 x ULN, or >5 x ULN in subjects who have documented liver metastases. o Bilirubin > ULN. o Hemoglobin <9 gm/dL 5. Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination. 6. The subject has a known history of positive test for Hepatitis B surface Antigen (HsbAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV). 7. The subject has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at Baseline Visit that in the Investigator’s judgment would jeopardize subject enrollment or compliance with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression free survival (PFS) between the YM155 plus Docetaxel and the Docetaxel regimen.;Secondary Objective: • Objective response rate (ORR) • Overall survival (OS) • Duration of response (DOR) • Clinical benefit rate (CBR) • Time to response (TTR) • Safety and tolerability;Primary end point(s): The primary endpoint for the study is progression free survival (PFS). PFS is defined as the time from the date of randomization until objective tumor progression or death. Objective tumor progression includes radiological assessments by independent reviewers blinded for the treatment assignment.;Timepoint(s) of evaluation of this end point: After 67 Progression Free Events have been observed in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objective response rate - Overall survival - Duration of response - Clinical benefit rate - Time to response - Safety and Tolerability;Timepoint(s) of evaluation of this end point: After 67 Progression Free Events have been observed in the study. | — |
Countries
Belgium, Czech Republic, Germany, Ireland, Russian Federation, United Kingdom, United States
Contacts
Public ContactT.B Smagge
Astellas Pharma Global Development, Inc. (APGD)
Outcome results
None listed