Metastatic Breast Cancer
Conditions
Brief summary
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. The study aim to evaluate the safety and efficiency of mecapegfilgrastim for prophylaxis of dalpiciclib -induced neutropenia in patients with advanced HR+/HER2- breast cancer.
Interventions
Mecapegfilgrastim
DRUGdalpiciclib
dalpiciclib
DRUGexemestane, fulvestrant, letrozole, tamoxifen
endocrine therapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18. 2. Pathologically confirmed advanced HR+/HER2- breast cancer: there is evidence of focal recurrence or metastasis, which is not suitable for surgical resection or radiotherapy for the purpose of cure. 3. No more than one line of chemotherapy is allowed for patients with recurrent and metastatic diseases. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. For patients with brain metastases, there is need for local treatment, and the brain lesions are stable for ≥ 3 months, and no need for dexamethasone or mannitol. 6. Adequate organ function: (I) adequate hematologic function: hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥100×109/L; (II) adequate renal and hepatic function. 7. Negative pregnancy test.
Exclusion criteria
1. Previous pathological diagnosis of HER2 positive breast cancer. 2. Previous treatment with cdk4/6 inhibitors. 3. Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer treatment within 2 weeks before entering the trial. 4. Any other malignant tumor diagnosed within 3 years before entering the study, except non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment. 5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method) or combined hepatitis B and hepatitis C co-infection. 6. Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, persistent arrhythmia ≥ grade 2 (according to nci-ctcae version 5.0), atrial fibrillation at any level, coronary / peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism). 7. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days) | at the end of cycle 1 (each cycle is 28 days) | The incidence of grade ≥3 neutropenia in cycle 1: defined as ANC \<1.0×109/L at the end of Cycle 1 (each cycle is 28 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast-Q scores | through study completion, an average of 2 years | Breast-Q scores for patient's quality of life |
| Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Progression-free Survival |
| The incidence of grade ≥3 neutropenia at the end of all cycles (each cycle is 28 days) | through study completion, an average of 2 years | The incidence of grade ≥3 neutropenia of all cycles: defined as ANC \<1.0×109/L at the end of All Cycles (each cycle is 28 days). |
| Relative dose intensity of dalpiciclib | through study completion, an average of 2 years | Relative dose intensity of dalpiciclib |
| Objective response rate (ORR） | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Objective response rate |
| Overall Survival | From date of randomization until the date of death from any cause, assessed up to 60 months | Overall Survival |
Countries
China
Outcome results
None listed