Observing the effects of Sacituzumab Govitecan in metastatic breast cancer
A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients
This study is testing how well Sacituzumab Govitecan works and how safe it is for people with metastatic HER-2 negative breast cancer who have already tried at least two other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | gosatetuzumab, Sacituzumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06966141 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clinical outcomes and safety of Sacituzumab Govitecan in patients with metastatic HER-2 negative breast cancer. Participants must have previously received at least two systemic treatments for their condition. The study aims to gather real-world data on the effectiveness of this treatment in a diverse patient population. Regular follow-ups will be conducted to monitor patient responses and safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic triple-negative breast cancer or HR+/HER2- breast cancer who have undergone multiple prior treatments.
Not a fit: Patients with early-stage breast cancer or those who have not received prior systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Sacituzumab Govitecan for patients with advanced breast cancer.
How similar studies have performed: Other studies have shown promising results with Sacituzumab Govitecan in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged 18 or above; 2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2; 3. Unresectable or metastatic triple-negative breast cancer confirmed by tumor histology or cytology, and having received at least two systemic treatments previously (at least one of which was for metastatic disease); Or HR+/HER2- (IHC 0, 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer confirmed by tumor histology or cytology, with previous endocrine therapy and ≥2 lines of systemic therapy (for metastatic disease); 4. Receive gosatetuzumab treatment in the advanced stage; 5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups; 6. All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures. Exclusion Criteria: 1. Pregnant or lactating women; 2. Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study; 3. Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to. 4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses; 5. Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment; 6. Patients allergic to gosatetuzumab; 7. Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons; 8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jian Zhang, MD,PhD — Fudan University
- Study coordinator: Jian Zhang, MD,PhD
- Email: syner2000@163.com
- Phone: +8664175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.