Breast cancer
Conditions
Interventions
None listed
Sponsors
CSPOR-BC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Women 20 years older who are diagnosed with histologically confirmed primary breast cancer. 2)Women whose breast cancer is estrogen receptor ER positive and human epidermal growth factor receptor 2 HER2 negative. 3)Women who are diagnosed with difficult to treat metastatic breast cancer. 4)Women with a history of chemotherapy after diagnosis of metastatic breast cancer. 5)Women who plan to receive treatment with abemaciclib. 6)Women who are scheduled to start abemaciclib treatment from 21 days or later after the completion of the previous chemotherapy and 14 days or later after the completion of radiotherapy. 7)Women with no recent history of treatment with CDK4/6 inhibitors. 8)Women with no previous history of treatment with abemaciclib. women with an ECOG PS of 0 2. 9)Women whose vital organ function is normal. 10)Women from whom written informed consent to participate in the study is obtained. Women who meet any of the following exclusion criteria are excluded.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1)Women for whom endocrine therapy is not indicated. 2)Women who require oxygen inhalation because of dyspnea under resting conditions. 3)Women who have previous history of gastrectomy or small bowel resection, except for mucosal resection. 4)Women who have Crohns disease, ulcerative colitis, or chronic diarrhea of Grade 2 or higher. 5)Women who are pregnant or nursing. 6)Women undergoing treatment for bacterial or fungal infection. 7)Women who have active hepatitis B or C. 8)Women who have serious cardiac disease. 9)Women whose primary care physicians considered that they are unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Time to Treatment Failure, Response Rate, Clinical Benefit Rate, and Adverse Events | — |
Countries
Japan
Contacts
Public ContactKazutaka Narui
Yokohama City University Medical Center Breast and Thyroid Surgery
Outcome results
None listed