Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer

NCT07018427 | Active Not Recruiting

• 1 other identifier: RWS119351420
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after the last patient was enrolled

Secondary Outcomes (3)

• Real world objective response rate (rwORR)

  approximately up to 24 weeks from the initiation of the study treatment.

• Real world overall survival (rwOS)

  up to 48 months from the initiation of the study treatment.

• Number of patients with adverse events

  approximately up to 68 weeks from the initiation of the treatment.

Study Arms (1)

Patients received SG

HER2-negative breast cancer patients who received SG treatment in the advanced stage

Drug: Sacituzumab Govitecan Monotherapy or Combination Therapy

Interventions

Sacituzumab Govitecan Monotherapy or Combination Therapy DRUG

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.

Also known as: SG

Patients received SG

Eligibility Criteria

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

Study Population

Patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer received SG

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)