Metastatic Breast CancerPhase 2NCT05463601
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer
A Phase 2 study testing Mecapegfilgrastim, dalpiciclib and exemestane, fulvestrant, letrozole, tamoxifen in people with Metastatic Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Mecapegfilgrastim, dalpiciclib and exemestane, fulvestrant, letrozole, tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Mecapegfilgrastim, dalpiciclib, exemestane, fulvestrant, letrozole, tamoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecapegfilgrastimDrug
Mecapegfilgrastim
dalpiciclibDrug
dalpiciclib
exemestane, fulvestrant, letrozole, tamoxifenDrug
endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| Mecapegfilgrastim +dalpiciclib + endocrine therapy | Experimental | Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) Receives: Drug: Mecapegfilgrastim; Drug: dalpiciclib; Drug: exemestane, fulvestrant, letrozole, tamoxifen |
| dalpiciclib + endocrine therapy | Active comparator | dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) Receives: Drug: dalpiciclib; Drug: exemestane, fulvestrant, letrozole, tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: through study completion, an average of 2 years
Breast-Q scores
Breast-Q scores for patient's quality of life
Measured: through study completion, an average of 2 years
Progression-free Survival
Progression-free Survival
Measured: 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
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Relative dose intensity of dalpiciclib
Relative dose intensity of dalpiciclib
Measured: through study completion, an average of 2 years
Objective response rate (ORR）
Objective response rate
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Aug 2022
- Primary completion31 Jan 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Jieqiong Liu, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463601
- Sponsor's protocol ID
- SYSKY-2022-105-01
- Status last verified
- May 2025
- First submitted
- 1 Jun 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05463601
- Acronym / sponsor ID
- SYSKY-2022-105-01
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mecapegfilgrastim +dalpiciclib + endocrine therapy | Experimental | Drug: Mecapegfilgrastim, Drug: dalpiciclib, Drug: exemestane, fulvestrant, letrozole, tamoxifenMecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) |
| dalpiciclib + endocrine therapy | Active comparator | Drug: dalpiciclib, Drug: exemestane, fulvestrant, letrozole, tamoxifendalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MecapegfilgrastimMecapegfilgrastim | Drug | Mecapegfilgrastim +dalpiciclib + endocrine therapy |
| dalpiciclibdalpiciclib | Drug | Mecapegfilgrastim +dalpiciclib + endocrine therapy, dalpiciclib + endocrine therapy |
| exemestane, fulvestrant, letrozole, tamoxifenendocrine therapy | Drug | Mecapegfilgrastim +dalpiciclib + endocrine therapy, dalpiciclib + endocrine therapy |
Primary outcome
The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days)
Time frame: 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).
6 secondary outcomes
The incidence of grade ≥3 neutropenia at the end of all cycles (each cycle is 28 days)
Time frame: through study completion, an average of 2 years
Breast-Q scores
Time frame: through study completion, an average of 2 years
Progression-free Survival
Time frame: 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
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Relative dose intensity of dalpiciclib
Time frame: through study completion, an average of 2 years
Objective response rate (ORR）
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mecapegfilgrastim, dalpiciclib and exemestane, fulvestrant, letrozole, tamoxifen in people with Metastatic Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days) (time frame: at the end of cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.