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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ribociclib; abemaciclib; palbociclib; Dalpiciclib
DrugNeoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days. CDK4/6 inhibitors (choose one of the following four types): * Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off) * Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off) * Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated) * Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
The main effect evaluation index was Objective response rate (ORR) after CDK4/6 inhibitor combined with endocrine, a total of 6 cycles.
Time frame
At the end of Cycle 6 (each cycle is 28 days)Secondary outcomes
1
Ki67 variations
Tumor samples were collected by surgical resection during the screening period (mandatory), at the time of treatment for 8 weeks (mandatory), and at the time of surgery (mandatory). Each test center was responsible for collecting samples, and the Hubei cancer Hospital determined the levels of Ki67.
Time frame
At the end of Cycle 2(each cycle is 28 days)2
complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%)
Ki67 levels were assessed through serial biopsies at baseline , before ET treatment and C2D28 after ET treatment
Time frame
6 months3
iDFS
Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.
Time frame
2 years4
QoL
Life quality score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.
Time frame
1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hongmei Zheng, PhD
Lead sponsor
Hubei Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: