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Sacituzumab Govitecan and Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases

Study Aim

This phase 2 study aims to evaluate the treatment effectiveness by assessing the proportion of patients with HER2-negative breast cancer brain metastases who are free of central nervous system progression at 1 year after receiving Sacituzumab Govitecan and head radiotherapy.

What is being tested

Sacituzumab Govitecan

+ Radiotherapy

DrugRadiation

Who is being recruted

Brain Diseases+9

+ Brain Neoplasms

+ Breast Diseases

From 18 to 75 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorGuangzhou Medical University

Study ContactZhenyu PanMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 15, 2024

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new combination treatment for patients with brain metastases from Her2-negative breast cancer. Her2-negative breast cancer is a type where the cancer cells do not have a protein called human epidermal growth factor receptor 2, which can affect treatment choices. The study is testing if using a drug called Sacituzumab Govitecan along with targeted head radiotherapy can be more effective in treating brain metastases. This research is important as it aims to find better treatment options for patients who currently have limited choices, potentially improving outcomes and quality of life. In this study, participants receive Sacituzumab Govitecan through an intravenous infusion, administered on the first and eighth day of a 21-day cycle. After the second dose of the drug, participants start receiving radiotherapy on the ninth day. The radiotherapy targets brain metastases with specific doses, and the amount depends on the location and number of lesions. The study continues this treatment plan until the cancer progresses or side effects become too severe. By observing how patients respond to this combination, researchers aim to evaluate both the effectiveness and safety of the treatment.

Official TitleA Phase II Clinical Study of Sacituzumab Govitecan Combined With Head Radiotherapy for the Treatment of Brain Metastases From Her2-negative Breast Cancer

NCT06462079

Principal SponsorGuangzhou Medical University

Study ContactZhenyu PanMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

43 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsBreast DiseasesBreast NeoplasmsCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsSkin DiseasesCentral Nervous System NeoplasmsSkin and Connective Tissue Diseases

Criteria

3 inclusion criteria required to participate

Have a definitive pathologic diagnosis of breast cancer with subtype Her2- (including IHC 0, IHC 1+ or IHC 2+ and ISH negative);

Have a measurable intracranial lesion;

Age ≥ 18 years;

8 exclusion criteria prevent from participating

Patients with cerebrospinal membrane metastases;

Patients with acute/subacute hemorrhagic metastasis;

Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb ≤ 90g/L; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal; 3) ALT and AST ≥ 2.5 times the upper limit of normal;

Presence of serious and/or uncontrolled comorbidities that may affect participation: 1) allergy to study medications or adjuvant materials; 2) history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases; 3) serious concomitant illnesses;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients were treated with Sacituzumab Govitecan 10 mg/kg in 21-day treatment cycles with intravenous infusions on days 1 and 8 and continued until disease progression or unacceptable toxicity. Radiotherapy was administered after the second infusion of Sacituzumab Govitecan, on day 9 after the start of this regimen. The radiotherapy regimen was: brain metastases at a dose of 60 Gy/20 doses. For lesions located adjacent to the brainstem and optic nerve, 54 Gy/20 doses were given. For patients with ≥5 lesions, whole-brain radiotherapy at 40 Gy/20 doses was synchronized with radiotherapy to localized brain metastases.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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