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Breast Cancer MetastaticPhase 2NCT06616987

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer

A Phase 2 study testing Sacituzumab Govitecan with pegfilgrastim in people with Breast Cancer Metastatic, run by Yeon Hee Park at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Breast Cancer Metastatic
What is being tested?
Sacituzumab Govitecan with pegfilgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
3 Jul 2025to 31 Dec 2027
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
  • Patients aged ≥19 years at the time of signing ICF.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of ≥ 12 weeks.
  • Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as <1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by IHC or 2+ and negative by in situ hybridization [ISH) test].
  • Metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
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  • Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or MBC. PARP inhibitor could have been counted as prior chemotherapy for purposes of study eligibility.
  • All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient.
  • Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1. Patients with bone-only metastases are also eligible.
  • Brain MRI must be done for patients with suspicion of brain metastases and patient must have stable central nervous system (CNS) disease for at least 4 weeks after local therapy, without neurological symptoms, and off anticonvulsants and steroids (no more than 10mg/day prednisone or its equivalent) for at least 2 weeks before first dose of study treatment.
  • Meet the following organ function requirements:
  • Hemoglobin ≥ 9 g/dL
  • ANC ≥ 1500/mm3
  • Platelets ≥ 100,000/μL
  • Bilirubin ≤ 1.5 X IULN or ≤ 3X IULN for patients with documented Gilbert's syndrome
  • AST and ALT ≤ 2.5 X IULN or ≤ 5 X IULN if known liver metastases
  • Serum albumin > 3 g/dL
  • Creatinine clearance ≥ 60 mL/min or ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
  • INR/PT and PTT or aPTT ≤ 1.5 X IULN unless patient is currently receiving therapeutic anticoagulant therapy
  • Resolution of all acute AEs of prior anti-cancer therapy to grade 1 as determined by the NCI-CTCAE v.5.0 (except for alopecia or other toxicities not considered a safety risk for the patient at investigator discretion).
  • Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception during treatment with sacituzumab govitecan and for 6months after the last dose.
  • Required contraception for female of childbearing potential patients using hormonally based method, intrauterine device (IUD), bilateral tubal occlusion, female condom with spermicide should during study period and continue until 6 months after the last dose of latest administered study drug
  • Required contraception for male patients using abstinence, male condom with spermicide, vasectomy should during study period and continue until 6 months after the last dose of latest administered study drug
  • Patients must have completed all prior cancer treatments at least 2 weeks prior to 1st infusion of study drug including chemotherapy (includes also endocrine treatment), radiotherapy, and major surgery.
  • Prior anticancer biologic agent must have been completed at least 4 weeks prior to 1st infusion of study drug.

Who cannot join

  • Prior treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
  • Received any prior treatment with a Trop-2-directed ADC.
  • Patients with carcinomatous meningitis.
  • Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
  • Patients positive for HIV-1 or -2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Have active hepatitis B virus (HBV) (defined as having a positive hepatitis B surface antigen test) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
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  • Patients who test positive for hepatitis B surface antigen will be excluded.
  • Patients who test positive for hepatitis B core antibody will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. Patients with positive hepatitis B core antibody but negative viral load by PCR may be eligible if they are being monitored for potential viral reactivation or are willing to start or maintain antiviral treatment during study conduction (as dictated by their local and institutional standard practice or guidelines). A patient with a history of HBV infection and presence of hepatitis B surface antibody may participate in the study. In this last scenario, viral load (HBV DNA) is not mandated.
  • Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.
  • Scheduled surgery during the study, other than minor surgery which would not delay study drug (eg, port insertion, tooth extraction, any procedure that requires < 1-hour general anesthesia. Procedures performed under local or intravenous (IV)/monitored sedation that lasts < 2 hours are acceptable).
  • Have an active second malignancy. Note: Patients with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision carcinoma in situ, or similar) are eligible.
  • Known history of clinically significant bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of study initiation.
  • Active or prior documented inflammatory bowel disease (i.e. Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).
  • Infection requiring antibiotic use within 1 week of 1st infusion of study drug.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
  • Women who are pregnant or lactating.
  • Concomitant participation in other interventional clinical trial. Note: Patients participating in observational studies are eligible.
  • Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study
  • Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yeon Hee Park, Ph.D contact

82-2-3410-3459

yhparkhmo@gmail.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Yeon Hee Park

    Recruiting

Other trials in South Korea

About this study

Official title: A Multicenter, Open-label, Single-arm, Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens

Read the detailed description

▪ Sacituzumab Govitecan group

  • Sacituzumab Govitecan 10mg/kg IV on CnD1 and D8 + Pegfilgrastim 6mg SC QD on CnD9
Being tested
Sacituzumab Govitecan with pegfilgrastim

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan with pegfilgrastimDrug

    ▪ Sacituzumab Govitecan group

    • Sacituzumab Govitecan 10mg/kg IV on CnD1 and D8 + Pegfilgrastim 6mg SC QD on CnD9
Study groups in NCT06616987
Study groupRoleWhat they receive
mTNBC patient who is administered with Sacituzumab GovitecanExperimental▪ Sacituzumab Govitecan group - Sacituzumab Govitecan 10mg/kg IV on CnD1 and D8 + Pegfilgrastim 6mg SC QD on CnD9
Receives: Drug: Sacituzumab Govitecan with pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the incidence of grade ≥3 neutropenia

    Incidence of grade ≥3 neutropenia after 2 cycles of treatment

    Measured: At the end of Cycle 2 (each cycle is 21 days)

Secondary outcomes (4)

  1. Safety and tolerability of the study regimen

    Incidence of AEs

    Measured: Up to 5 years

  2. Objective Response Rate

    The percentage of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by investigator per RECIST v1.1

    Measured: Up to 5 years

  3. Progression Free Survival

    Measured: Up to 5 years

  4. Overall Survival

    The time until defined by date of all-cause mortality from the date of 1st infusion The time until defined by date of all-cause mortality from the date of 1st infusion

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start3 Jul 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616987
Sponsor's protocol ID
2024-09-028
Status last verified
Aug 2025
First submitted
19 Sep 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan with pegfilgrastim in people with Breast Cancer Metastatic, run by Yeon Hee Park at 1 site in South Korea.

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 25 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 28 Aug 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 South Korea. 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?

Contact Yeon Hee Park, Ph.D (82-2-3410-3459, yhparkhmo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the incidence of grade ≥3 neutropenia (time frame: At the end of Cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616987.

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 28 Aug 2025.

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