Sacituzumab Govitecan for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option called sacituzumab govitecan (an antibody-drug conjugate) for individuals with advanced breast cancer that is hormone-sensitive and HER2-negative. The aim is to determine if this treatment can benefit patients whose cancer has progressed despite previous therapies, such as CDK4/6 inhibitors and trastuzumab deruxtecan. Researchers seek to understand the effectiveness of sacituzumab govitecan when used after trastuzumab deruxtecan. Suitable candidates have breast cancer deemed incurable by surgery but have received specific prior therapies, including chemotherapy and trastuzumab deruxtecan. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients with stable doses of anticonvulsants and corticosteroids can participate, suggesting some medications may be allowed.
Is there any evidence suggesting that sacituzumab govitecan is likely to be safe for humans?
Previous studies have shown that sacituzumab govitecan (SG) is generally well-tolerated by breast cancer patients. Research indicates that SG's safety profile aligns with earlier findings, revealing no new safety concerns. A detailed review and analysis demonstrated that SG is effective and tolerable, with only minor side effects reported. While some side effects may occur, they are usually manageable. Overall, SG has been used safely in other cancer patients, supporting its use in ongoing research.12345
Why do researchers think this study treatment might be promising for breast cancer?
Sacituzumab Govitecan is unique because it combines an antibody with a cancer-killing drug, specifically targeting the Trop-2 protein found on many breast cancer cells. This targeted approach allows for more precise delivery of the chemotherapy directly to the cancer cells, potentially reducing damage to healthy cells and minimizing side effects. Researchers are excited about this treatment because it offers a novel mechanism of action compared to conventional chemotherapy, which typically affects both cancerous and healthy cells indiscriminately. Additionally, Sacituzumab Govitecan has shown promise in patients who have not responded to other treatments, providing hope for those with limited options.
What evidence suggests that sacituzumab govitecan might be an effective treatment for breast cancer?
Studies have shown that sacituzumab govitecan effectively treats certain types of breast cancer. This treatment targets Trop-2, a protein often found in high amounts on cancer cells, and delivers a potent drug that halts cancer cell growth. Research indicates that sacituzumab govitecan can help patients live longer without disease progression and can also increase overall survival in patients with HR+/HER2- breast cancer. In some studies, patients treated with this drug achieved better results compared to other treatments. Although there is interest in using sacituzumab govitecan after trastuzumab deruxtecan, more specific evidence is needed for this sequence. Participants in this trial will receive sacituzumab govitecan as the investigational treatment.15678
Are You a Good Fit for This Trial?
This trial is for individuals with advanced hormone-positive, HER2-negative metastatic breast cancer who have already undergone treatment with CDK4/6 inhibitors and endocrine therapy. Participants will be selected based on their genetic makeup from tumor biopsies to find those likely to respond to the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biopsy and Sequencing
Tumor specimens are collected from biopsies, and whole genome and transcriptome sequencing is performed
Treatment
Patients receive sacituzumab govitecan (SG) at an initial dose of 10 mg per kilogram intravenously on day 1 and 8 of 21 day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sacituzumab Govitecan
Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:
- Metastatic triple-negative breast cancer
- Locally advanced or metastatic urothelial cancer (withdrawn)
- Metastatic HR+/HER2- breast cancer
- Metastatic triple-negative breast cancer
- Metastatic triple-negative breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine