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

Phase 2

Active, not recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Mecapegfilgrastim; Drug: exemestane, fulvestrant, letrozole, tamoxifen; Drug: dalpiciclib

• Registration Number: NCT05463601
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-19
• Study Start: 2022-08-01
• Primary Completion: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dalpiciclib + endocrine therapy	exemestane, fulvestrant, letrozole, tamoxifen	dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Mecapegfilgrastim +dalpiciclib + endocrine therapy	Mecapegfilgrastim	Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Mecapegfilgrastim +dalpiciclib + endocrine therapy	exemestane, fulvestrant, letrozole, tamoxifen	Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
Mecapegfilgrastim +dalpiciclib + endocrine therapy	dalpiciclib	Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
dalpiciclib + endocrine therapy	dalpiciclib	dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
Breast-Q scores	through study completion, an average of 2 years	Breast-Q scores for patient's quality of life
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
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

Trial Locations

Locations (1)

中山大学中山纪念医院; 🇨🇳 Guangzhou, Guangdong, China