Breast NeoplasmsNCT07018427
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
An observational study of Breast Neoplasms and Triple Negative Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Triple Negative Breast Cancer, HR+, HER2-, Advanced Breast Cancer
- What is being tested?
- Sacituzumab Govitecan Monotherapy or Combination Therapy
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Sep 2025
- Phase
- Observational
- 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
Study population: Patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer received SG
Who may be able to join
- Age and Gender Male or female aged 18 years or older.
- Pathological Diagnosis and Classification Criteria (Must Meet Either Cohort Condition) 2.1 Triple-Negative Breast Cancer (TNBC) Cohort
- Histologically/cytologically confirmed triple-negative breast cancer (TNBC) by pre-SG biopsy/pathology report, with the following criteria:
- HER2-negative: Immunohistochemistry (IHC) score of 0 or 1+; if IHC score is 2+, HER2 negativity must be confirmed by fluorescence in situ hybridization (FISH).
- Estrogen and progesterone receptor-negative: <1% of cells express hormone receptors as determined by IHC.
- Presence of locally advanced, recurrent, or metastatic disease (locally advanced disease must be confirmed by investigators as ineligible for curative resection).
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- 2.2 Hormone Receptor-Positive/HER2-Negative Breast Cancer (HR+/HER2- BC) Cohort
- Histologically/cytologically confirmed HR+/HER2- breast cancer by pre-SG biopsy/pathology report, with the following criteria:
- HER2-negative: Immunohistochemistry (IHC) score of 0 or 1+; if IHC score is 2+, HER2 negativity must be confirmed by fluorescence in situ hybridization (FISH).
- HR-positive: Hormone receptor positivity (HR, including ER or PR status) is defined as ≥1% cell expression by IHC.
- Presence of locally advanced, recurrent, or metastatic disease (locally advanced disease must be confirmed by investigators as ineligible for curative resection).
- Treatment Protocol Requirements Planned to receive SG monotherapy or combination therapy.
- Other Enrollment Criteria Willing to participate in the study, sign the informed consent form, and demonstrate good compliance.
Who cannot join
- Pregnant or lactating women.
- Known allergy to sacituzumab govitecan (SG) or any of its components.
- History of other malignancies, except the following:
- Cured basal cell carcinoma, squamous cell skin carcinoma, cervical in situ carcinoma, or papillary thyroid carcinoma.
- A second primary cancer that has been completely cured with a tumor-free interval of ≥5 years.
- Other malignancies where the primary tumor source of metastatic foci has been clearly identified by investigators.
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- Diagnosis of other malignancies within the past 5 years
- Current participation in other interventional clinical studies.
- Presence of acute or chronic infections, or coexisting serious diseases (such as decompensated heart, lung, liver, or renal failure), assessed by investigators as incompatible with tolerating the study treatment.
- Mental illness or psychiatric disorders leading to poor compliance, inability to cooperate with the study, or inability to describe treatment responses.
- Modification of the treatment regimen after SG administration for reasons other than disease progression.
- Any other circumstances deemed by investigators as likely to interfere with study evaluation, affect subject safety, or render the patient unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100010
About this study
Official title: Efficacy and Safety of Sacituzumab Govitecan in Heavily Pretreated Unresectable Locally Advanced, Recurrent, or Metastatic HER2-Negative Breast Cancer: A Multicenter Real-World Study
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. The study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.
- Conditions
- Breast Neoplasms, Triple Negative Breast Cancer, HR+, HER2-, Advanced Breast Cancer, Breast Cancer
- Being tested
- Sacituzumab Govitecan Monotherapy or Combination Therapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan Monotherapy or Combination TherapyDrug
Also called SG
The interventions in this study comprised either Sacituzumab Govitecan monotherapy or combination therapy. The specific combination regimens were determined based on real - world clinical practice patterns.
| Study group | Role | What they receive |
|---|---|---|
| Patients received SG | HER2-negative breast cancer patients who received SG treatment in the advanced stage Receives: Drug: Sacituzumab Govitecan Monotherapy or Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real world progression free survival (rwPFS)
The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
Measured: 12 months after the last patient was enrolled
Secondary outcomes (3)
Real world objective response rate (rwORR)
The percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS)
Time from initiation of SG monotherapy or combination therapy to death from any cause
Measured: up to 48 months from the initiation of the study treatment.
Number of patients with adverse events
Adverse events were assessed during study treatment and at follow-up visits
Measured: approximately up to 68 weeks from the initiation of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 May 2023
- Primary completion1 May 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, songguohong, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018427
- Sponsor's protocol ID
- RWS119351420
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sacituzumab Govitecan in Heavily Pretreated Unresectable Locally Advanced, Recurrent, or Metastatic HER2-Negative Breast Cancer: A Multicenter Real-World Study
- ClinicalTrials.gov ID
- NCT07018427
- Acronym / sponsor ID
- RWS119351420
- Conditions
- Breast Neoplasms, Triple Negative Breast Cancer, HR+, HER2-, Advanced Breast Cancer, Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Jun 2025 (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.
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. The study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients received SG | – | Drug: Sacituzumab Govitecan Monotherapy or Combination TherapyHER2-negative breast cancer patients who received SG treatment in the advanced stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer received SG
Key inclusion criteria (13 listed)
- Age and Gender Male or female aged 18 years or older.
- Pathological Diagnosis and Classification Criteria (Must Meet Either Cohort Condition) 2.1 Triple-Negative Breast Cancer (TNBC) Cohort
- Histologically/cytologically confirmed triple-negative breast cancer (TNBC) by pre-SG biopsy/pathology report, with the following criteria:
- HER2-negative: Immunohistochemistry (IHC) score of 0 or 1+; if IHC score is 2+, HER2 negativity must be confirmed by fluorescence in situ hybridization (FISH).
- Estrogen and progesterone receptor-negative: <1% of cells express hormone receptors as determined by IHC.
Key exclusion criteria (12 listed)
- Pregnant or lactating women.
- Known allergy to sacituzumab govitecan (SG) or any of its components.
- History of other malignancies, except the following:
- Cured basal cell carcinoma, squamous cell skin carcinoma, cervical in situ carcinoma, or papillary thyroid carcinoma.
- A second primary cancer that has been completely cured with a tumor-free interval of ≥5 years.
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 |
|---|---|---|
| Sacituzumab Govitecan Monotherapy or Combination TherapyAlso: SGThe interventions in this study comprised either Sacituzumab Govitecan monotherapy or combination therapy. The specific combination regimens were determined based on real - world clinical practice patterns. | Drug | Patients received SG |
Primary outcome
Real world progression free survival (rwPFS)
Time frame: 12 months after the last patient was enrolled
The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
3 secondary outcomes
Real world objective response rate (rwORR)
Time frame: approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS)
Time frame: up to 48 months from the initiation of the study treatment.
Number of patients with adverse events
Time frame: approximately up to 68 weeks from the initiation of the treatment.
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 12 Jun 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Breast Neoplasms and Triple Negative Breast Cancer, run by Peking University Cancer Hospital & Institute 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 13 inclusion and 12 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 12 Jun 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.
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?
Real world progression free survival (rwPFS) (time frame: 12 months after the last patient was enrolled). 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 12 Jun 2025.