Overview

Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Treatments:
Exemestane
Fulvestrant
Letrozole
Tamoxifen
Criteria
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. Measurable lesions meeting RECIST 1.1 criteria or only bone metastases.

6. 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.

7. Adequate organ function: (I) adequate hematologic function: hemoglobin ≥90 g/L,
absolute neutrophil count (ANC) ≥2.0×109/L, platelet count (PLT) ≥100×109/L; (II)
adequate renal and hepatic function.

8. Negative pregnancy test.

Exclusion Criteria:

1. Previous pathological diagnosis of HER2 positive breast cancer.

2. Relapse and metastasis occurred after receiving neoadjuvant endocrine therapy or
adjuvant therapy for 2 years, or disease progression or recurrence occurred within 12
months or 12 months after completion of adjuvant endocrine therapy.

3. Previous treatment with cdk4/6 inhibitors.

4. Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer
treatment within 2 weeks before entering the trial.

5. 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.

6. 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.

7. 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).

8. Inability to swallow, intestinal obstruction or other factors affecting drug
administration and absorption.