Recruiting NCT06301438
Dalpiciclib in HR+/HER2- ABC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dalpiciclib.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study
Overview
To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.
Interventions
- Drug dalpiciclib
dalpiciclib oral day 1-21, every 28 days
Primary outcome measures
- Progression-Free Survival [Time frame: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)]
Secondary outcome measures (1)
- Adverse events [Time frame: From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai
Identifiers
NCT: NCT06301438 · LY2024-022-A