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Trial Title:
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer
NCT ID:
NCT05578053
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
a new, orally administered, selective CDK4/6 inhibitor
Arm group label:
locally advanced/metastatic HR+ breast cancer patients
Other name:
SHR-6390
Summary:
This study is a multi-center, observational, real-world study. We planned to recruit 420
HR+ locally advanced or metastatic breast cancer patients who had received or had not
received prior systemic therapy. All patients included in the analysis were receiving or
planning to receive dalpiciclib-containing regimens without restrictions, completely
following the physician 's clinical choice, to assess the efficacy and safety of
dalpiciclib-containing regimens.
Detailed description:
All patients included in the analysis were receiving or were planning to receive
dalpiciclib and other standard therapy, with no restrictions on the regimen and full
adherence to physician clinical choices. Patients who qualified after completing the
screening tests and assessments entered the study treatment period and were treated and
visited with a dalpiciclib -containing regimen as specified in the protocol. Patients
underwent imaging assessments and safety assessments according to clinical routine during
study treatment, with the investigator 's assessment as the final result.
Criteria for eligibility:
Study pop:
HR+ postmenopausal/premenopausal locally advanced/metastatic breast cancer patients who
had received or had not received prior systemic therapy were planned to be enrolled in
the study
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. age ≥ 18 years, postmenopausal or premenopausal female or male patients, female
patients must meet one of the following: a) previous bilateral oophorectomy, or age
≥ 60 years; b) age < 60, natural postmenopausal status (defined as spontaneous
cessation of regular menstruation for at least 12 consecutive months without other
pathological or physiological causes), E2 and FSH at postmenopausal levels; c)
premenopausal or perimenopausal female patients can also be enrolled, but must be
willing to receive LHRH agonist therapy during the study;
2. pathological examination confirmed HR-positive male/female breast cancer patients,
with evidence of focal recurrence or metastasis, not suitable for surgical resection
or radiation therapy with the purpose of cure;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Serum pregnancy test must be performed within 28 days before enrollment in women of
childbearing age and the result is negative,And male/female patients are willing to
use a medically recognized highly effective contraceptive during the study and
within 1 year after the last dose of study drug;
5. non-pregnant or non-lactating female patients；
6. do not participate in other ongoing studies at the same time ；
7. agreed by the patient himself or her legal representative and have signed an
informed consent form, willing and able to comply with scheduled visits, study
treatment plan, laboratory tests and other trial procedures.
Exclusion Criteria:
1. any evidence of serious or uncontrolled systemic disease, including uncontrolled
hypertension, active bleeding disorders, active infections, including hepatitis B,
C, and human immunodeficiency virus, or severely impaired bone marrow reserve or
organ function, including liver and kidney damage, which, in the opinion of the
investigator, would greatly alter the balance of wind benefit/risk.
2. at the time of initiation of dalpiciclib treatment, the patient has not recovered
from any CTCAE grade ≥ 3 toxicity caused by previous treatment
3. known history of hypersensitivity to dalpiciclib or excipients or drugs with similar
chemical structure to dalpiciclib
4. patients who are considered unsuitable for inclusion by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 26, 2022
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Source:
Hebei Medical University Fourth Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05578053
