Early Breast Cancer
Conditions
Interventions
None listed
Sponsors
Showa University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Provision of patient informed consent (or consent from next of kin/legal representative, if applicable) for use of patients' secondary data or appropriate informed consent waiver according to local regulations. 2.Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative patients with early breast cancer at high-risk of recurrence receiving abemaciclib following surgery. a. Early-stage breast cancer is defined as no record of stage IV or metastatic disease from breast cancer diagnosis date to abemaciclib start date. b. For patients enrolled in France, UK, Spain and Japan, the definition of high-risk is: i. either >=4 positive axillary lymph nodes (pALN), ii. or 1-3 pALN and at least one of the following criteria: tumour size >=5 cm or histological grade 3. c. For patients enrolled in Brazil, the definition of high-risk is: i. either >=4 positive axillary lymph nodes (pALN), ii. or 1-3 pALN and at least one of the following criteria: tumour size >=5 cm or histological grade 3, iii. or 1-3 pALN and Ki67 index >=20%. 3.Patients receiving a starting dose of abemaciclib of 150 mg twice per day in combination with an aromatase inhibitor or tamoxifen.
Exclusion criteria
Exclusion criteria: 1. Patients who received treatment with abemaciclib as part of a clinical trial. 2. Patients who received abemaciclib as part of an early access programme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. i. Proportion of patients still receiving abemaciclib treatment 6 months after starting treatment. ii. Proportion of patients who discontinue abemaciclib over the first 6 months and reasons for discontinuation. 2. i. Demographic characteristics at abemaciclib start. ii. Clinical characteristics up to abemaciclib start. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints 1 i. Summary of the treatment duration of abemaciclib over the study period. ii. Proportion of patients who remain on abemaciclib at 30 days and 3 months following treatment start. iii. Proportion of patients who discontinue abemaciclib and reasons for discontinuation over the entire follow-up period. iv. Dose changes following treatment start and reasons for change. v. Starting combination hormonal agent and starting dose of combination hormonal therapy. vi. Proportion of patients who remain on combination hormonal therapy 6 months after starting abemaciclib treatment. 2 i. Description of surgery received prior to and following abemaciclib, overall and by type of surgery, and outcomes following surgery. ii. Description of hormonal, chemotherapy, and other treatments received prior to and following abemaciclib + combination hormonal agent, overall and by drug. iii. Description of radiotherapy received prior to and following abemaciclib. iv. Description of the time from definitive breast cancer surgery to adjuvant treatment start. v. Description of the time from definitive breast cancer surgery to abemaciclib treatment start. vi. Description of the time from start of combination adjuvant endocrine therapy to abemaciclib start. vii. Description of the time from the start of adjuvant chemotherapy to abemaciclib treatment start. viii. Description of the time from the start of adjuvant radiotherapy to abemaciclib treatment start. | — |
Countries
Japan,South America,Europe
Contacts
Public ContactHitomi Sakai
Showa University Advanced Cancer Translational Research Institute
Outcome results
None listed