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Trial Title:
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
NCT ID:
NCT06613373
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in
each 4-week cycle.
Arm group label:
experimental
Summary:
This is a single-arm, open-label, exploratory clinical study
Detailed description:
This is a single-arm, open-label, exploratory clinical study initiated by the
investigator to evaluate the objective response rate (ORR), efficacy, and safety of
Dalpiciclib combined with AI in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. For premenopausal or postmenopausal women, the definition of menopause:
1. previous bilateral oophorectomy, or age ≥60 years; or
2. 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; 2. All patients had
estrogen receptor (ER) positive (> 10%), HER2 receptor-negative invasive breast
cancer regardless of PR expression level. Follow the 2018 ASC-CAP HER2 Negative
Interpretation Guidelines. Immunohistochemical (IHC) scores of 0+ or 2+ and in situ
hybridization (ISH) test negative were confirmed by pathology laboratory
(HER-2/CEP17 ratio < 2.0); 3. Patients with initial treatment of stage II-III whose
tumor stage meets AJCC 8th edition standard; 4. There is no known severe
hypersensitivity to compounds or endocrine therapy similar to Darcilil or darcilil
excipients.
5. ECOG 0-1; 6. The patient must be able to swallow oral medications. 7. The functional
level of the organ must meet the following requirements:
1. Bone marrow function ANC ≥ 1.5×109/L (no growth factor used within 14 days); PLT ≥
100×109/L (no corrective therapy used within 7 days); Hb ≥ 100 g/L (no corrective
therapy used within 7 days);
2. Liver and kidney function TBIL≤1.5×ULN; ALT and AST≤3×ULN (ALT and AST≤5×ULN in
patients with liver metastasis); BUN and Cr≤1.5×ULN and creatinine clearance ≥50
mL/min (Cockcroft-Gault formula);
3. 12-lead electrocardiogram QT interval ≤480 ms; 8. Able to accept all needle biopsies
required by the protocol; 9. Voluntarily participate in this study, sign informed
consent, have good compliance and be willing to cooperate with follow-up.
Exclusion Criteria:
1. Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy,
molecular targeted therapy, endocrine therapy, etc.);
2. At the same time receive any anti-tumor treatment other than that prescribed in
other protocols;
3. Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
4. Stage IV breast cancer;
5. Other malignant tumors have appeared in the past 5 years;
6. Severe heart, liver, kidney and other vital organ dysfunction;
7. Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple
factors affecting drug use and absorption;
8. Known allergic history of the drug components of this protocol; Have a history of
immunodeficiency, including HIV positive, HCV, active viral hepatitis B or other
acquired, congenital immunodeficiency diseases, or a history of organ
transplantation;
9. Pregnant and lactating women, fertile women who tested positive for baseline
pregnancy tests, or women of childbearing age who were unwilling to take effective
contraceptive measures during the entire test period;
10. Concomitant diseases (including but not limited to severe high blood pressure,
severe diabetes, active infection, etc.) that, in the judgment of the investigator,
seriously endanger the patient's safety or affect the patient's ability to complete
the study;
11. Have a clear history of neurological or mental disorders, including epilepsy or
dementia. The investigator did not consider the patient suitable for participation
in any other condition of the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 15, 2024
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Jiangsu Famous Medical Technology Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Famous Medical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613373
