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

Metastatic Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Dalpiciclib -Induced Neutropenia in Patients With Advanced HR+/HER2- Breast Cancer: a Open-label, Multicenter, Investigator-initiated, Randomized Controlled Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463601
• Other study ID #: SYSKY-2022-105-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Neutropenia

Intervention

Drug:
• Mecapegfilgrastim
Mecapegfilgrastim
• dalpiciclib
dalpiciclib
• exemestane, fulvestrant, letrozole, tamoxifen
endocrine therapy

Locations

Country	Name	City	State
China	??????????	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of grade =3 neutropenia 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).	at the end of cycle 2 (each cycle is 28 days)
Secondary	The incidence of grade =3 neutropenia at the end of all cycles (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 All Cycles (each cycle is 28 days).	through study completion, an average of 2 years
Secondary	Breast-Q scores	Breast-Q scores for patient's quality of life	through study completion, an average of 2 years
Secondary	Progression-free Survival	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
Secondary	Overall Survival	Overall Survival	From date of randomization until the date of death from any cause, assessed up to 60 months
Secondary	Relative dose intensity of dalpiciclib	Relative dose intensity of dalpiciclib	through study completion, an average of 2 years