Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mecapegfilgrastim +dalpiciclib + endocrine therapy Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) |
Drug: Mecapegfilgrastim
Mecapegfilgrastim
Drug: dalpiciclib
dalpiciclib
Drug: exemestane, fulvestrant, letrozole, tamoxifen
endocrine therapy
|
| Active Comparator: dalpiciclib + endocrine therapy dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) |
Drug: dalpiciclib
dalpiciclib
Drug: exemestane, fulvestrant, letrozole, tamoxifen
endocrine therapy
|
Outcome Measures
Primary Outcome Measures
- The incidence of grade ≥3 neutropenia at the end of cycle 2 (each cycle is 28 days) [at the end of cycle 2 (each cycle is 28 days)]
The incidence of grade ≥3 neutropenia in cycle 2: defined as ANC <1.0×109/L at the end of Cycle 1 (each cycle is 28 days).
Secondary Outcome Measures
- 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 in cycle 2: defined as ANC <1.0×109/L at the end of All Cycles (each cycle is 28 days).
- 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
- Overall Survival [From date of randomization until the date of death from any cause, assessed up to 60 months]
Overall Survival
- Relative dose intensity of dalpiciclib [through study completion, an average of 2 years]
Relative dose intensity of dalpiciclib
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18.
-
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.
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No more than one line of chemotherapy is allowed for patients with recurrent and metastatic diseases.
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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Measurable lesions meeting RECIST 1.1 criteria or only bone metastases.
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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.
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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.
-
Negative pregnancy test.
Exclusion Criteria:
-
Previous pathological diagnosis of HER2 positive breast cancer.
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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.
-
Previous treatment with cdk4/6 inhibitors.
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Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer treatment within 2 weeks before entering the trial.
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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.
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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.
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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).
-
Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China | |
| 2 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | |
| 3 | Shantou Central Hospital | Shantou | Guangdong | China |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-BC-II-029