The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHongmei Zheng, PhD
About this trial
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.
Eligibility criteria
Qualifiers
Age ≥ 18 years old.
Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).
Patients must have histologically confirmed ER and/or PR >10%, HER2-, early invasive breast cancer.
Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases.
Disqualifiers
Prior treatment with any CDK inhibitor.
Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
History of anaphylaxis caused by chemical or biologic components similar to dalsily.
Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
Trial design
Treatments tested in this trial
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Hongmei Zheng, PhD
Lead sponsor
Hubei Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov