Evaluating the effectiveness of sacituzumab govitecan for metastatic triple-negative 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, prospective, multicenter study aims to collect data on the effectiveness and tolerability of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC). The study will evaluate histological and biomolecular characteristics of tumor samples from both primary and metastatic sites, as well as circulating plasma. Biomarkers predictive of treatment efficacy and tolerability will be identified through analysis of tumor tissue and plasma collected at two time points. Additionally, the feasibility of developing organoids and conducting single-cell sequencing will be assessed in a small subgroup of patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Histological diagnosis of TNBC;
* Locally advanced unresectable or metastatic disease;
* Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);
* Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);
* Written informed consent;
* Availability to comply with the procedures established by the protocol, according to the methods and times described.

Exclusion Criteria:

* Patients with a history of other malignancies;
* Contraindications to the use of sacituzumab govitecan SG;
* Untreated and/or clinically unstable (symptomatic) brain metastases.

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Rome, Italy Recruiting

Study contacts

• Principal investigator: Patrizia Vici, Doctor — IRCCS "Regina Elena" National Cancer Institute
• Study coordinator: Patrizia Vici, Doctor
• Email: patrizia.vici@ifo.it
• Phone: 06-5266.5584

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

• Genomic and transcriptomic markers predicting response to sacituzumab govitecan after trastuzumab deruxtecan in ER+/HER2-low metastatic breast cancer

  This trial will test whether DNA and RNA features from a fresh tumor biopsy can predict who responds to sacituzumab govitecan in people with ER-positive, HER2-low metastatic breast cancer who progressed after trastuzumab deruxtecan.

  Recruiting Phase 2 British Columbia Cancer Agency · Vancouver, British Columbia · NCT06665178

• Evaluating the effectiveness of sacituzumab govitecan in specific breast cancer patients

  This study is testing if a drug called sacituzumab govitecan can help people with advanced hormone receptor-positive breast cancer who have already been treated with another medication.

  Recruiting at 3 sites Phase 2 Baptist Health South Florida · Miami, Florida and 2 other locations · NCT06263543

• Combining Sacituzumab Govitecan and Zimberelimab with Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

  This study is testing if combining two treatments, Sacituzumab Govitecan and Zimberelimab, with targeted radiation can help adults with metastatic triple negative breast cancer that has spread to the brain feel better compared to just using Sacituzumab Govitecan alone.

  Recruiting Phase 1/2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT06238921

• Testing Sacituzumab Govitecan with or without Pembrolizumab for metastatic triple-negative breast cancer

  This study is testing whether a new cancer drug called Sacituzumab Govitecan, alone or with another drug called Pembrolizumab, can help people with metastatic triple-negative breast cancer that hasn't been treated before.

  Recruiting at 15 sites Phase 2 Dana-Farber Cancer Institute · Stamford, Connecticut and 14 other locations · NCT04468061

• Atezolizumab and sacituzumab govitecan to prevent recurrence in triple-negative breast cancer

  This trial tests whether combining sacituzumab govitecan with atezolizumab can prevent cancer from coming back in people with triple-negative breast cancer who have residual disease after pre-surgery chemotherapy and detectable circulating tumor DNA.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · San Francisco, California and 6 other locations · NCT04434040

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.