Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
Interventions
DRUGCDK4/6 inhibitor
abemaciclib OR ribociclib
Sponsors
Wenjin Yin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 and older * Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence * HR+/HER2- * ECOG 0-3 * Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
Exclusion criteria
* During pregnancy or lactation * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive Disease-free Survival (iDFS) | From the date of surgery until time of event up to 2 years. | Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) | From the date of surgery until time of event up to 2 years | Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause. |
| Overall Survival (OS) | From the date of surgery until time of event up to 2 years | Overall survival is defined as the time from surgery to death from any cause. |
| Adverse events | From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years) | Adverse events will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWenjin Yin, M.D.
Outcome results
None listed