Advanced Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.
Interventions
DRUGdalpiciclib
dalpiciclib oral day 1-21, every 28 days
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced breast cancer * Hormone receptor-positive and human epidermal growth factor receptor 2-negative * ECOG 0-1
Exclusion criteria
* Pregnant or breastfeeding * History of immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years) | The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year) | Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0. |
Countries
China
Contacts
CONTACTWenjin Yin
PRINCIPAL_INVESTIGATORWenjin Yin
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed