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

NCT05463601 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: SYSKY-2022-105-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The incidence of grade ≥3 neutropenia 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).

  at the end of cycle 1 (each cycle is 28 days)

Secondary Outcomes (6)

• 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

• Breast-Q scores

  through study completion, an average of 2 years

• 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

• Overall Survival

  From date of randomization until the date of death from any cause, assessed up to 60 months

• Relative dose intensity of dalpiciclib

  through study completion, an average of 2 years

Study Arms (2)

Mecapegfilgrastim +dalpiciclib + endocrine therapy

EXPERIMENTAL

Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Drug: Mecapegfilgrastim; Drug: dalpiciclib; Drug: exemestane, fulvestrant, letrozole, tamoxifen

dalpiciclib + endocrine therapy

ACTIVE COMPARATOR

dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)

Drug: dalpiciclib; Drug: exemestane, fulvestrant, letrozole, tamoxifen

Interventions

Mecapegfilgrastim DRUG

Mecapegfilgrastim

Mecapegfilgrastim +dalpiciclib + endocrine therapy

dalpiciclib DRUG

dalpiciclib

Mecapegfilgrastim +dalpiciclib + endocrine therapy; dalpiciclib + endocrine therapy

exemestane, fulvestrant, letrozole, tamoxifen DRUG

endocrine therapy

Mecapegfilgrastim +dalpiciclib + endocrine therapy; dalpiciclib + endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No more than one line of chemotherapy is allowed for patients with recurrent and metastatic diseases.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• 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.
• 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.
• Negative pregnancy test.

You may not qualify if:

• Previous pathological diagnosis of HER2 positive breast cancer.
• Previous treatment with cdk4/6 inhibitors.
• Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer treatment within 2 weeks before entering the trial.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

中山大学中山纪念医院

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegylated granulocyte colony-stimulating factor; dalpiciclib; exemestane; Fulvestrant; Letrozole; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 19, 2022
• Study Start: August 1, 2022
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)