Dalpiciclib in HR+/HER2- ABC
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed advanced breast cancer
Hormone receptor-positive and human epidermal growth factor receptor 2-negative
ECOG 0-1
Disqualifiers
Pregnant or breastfeeding
History of immunodeficiency
Trial population
Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
dalpiciclib
Drugdalpiciclib oral day 1-21, every 28 days
Treatment groups
103 Participants
are divided into 1 treatment groupGroup A: dalpiciclib1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival
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.
Time frame
From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)Secondary outcomes
1
Adverse events
Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.
Time frame
From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov