Observing the effects of Sacituzumab Govitecan in metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-line Sacituzumab Govitecan for Advanced Untreated Triple-Negative Breast Cancer

  This study tests whether Sacituzumab Govitecan can slow disease progression when given as a first treatment to adults with advanced triple-negative breast cancer who have not yet received treatment in the advanced setting.

  Recruiting Phase 2 British Columbia Cancer Agency · Vancouver, British Columbia · NCT07299409

• Sacituzumab govitecan for HER2‑negative metastatic breast cancer in China

  This will test how well sacituzumab govitecan works and how safe it is for adults in China with HER2‑negative metastatic breast cancer.

  Recruiting Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06784921

• Preventing neutropenia from sacituzumab govitecan in metastatic triple-negative breast cancer

  This trial tests sacituzumab govitecan given with pegfilgrastim to see if it prevents low white blood cell counts in people with metastatic triple-negative breast cancer who have had one or two prior chemotherapy regimens.

  Recruiting Phase 2 Samsung Medical Center · Seoul · NCT06616987

• Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage

  This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07885072

• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

  This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.