Sacituzumab Govitecan for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Sacituzumab Govitecan, an antibody-drug conjugate, can slow the progression of advanced triple-negative breast cancer (TNBC) in patients who have not yet received treatments for their advanced condition. It also investigates if the drug acts differently in patients with specific genetic profiles of cancer, known as HRD and non-HRD subtypes. The trial is suitable for individuals with advanced TNBC that is not amenable to surgery or radiotherapy and who have not yet received treatment for their advanced cancer. Participants will receive the drug on a set schedule and undergo regular follow-ups to monitor progress. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic therapy in the advanced setting and should not use certain high-dose corticosteroids close to the start of the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that Sacituzumab Govitecan is likely to be safe for humans?
Research shows that sacituzumab govitecan (SG) is generally well-tolerated by people with advanced triple-negative breast cancer (TNBC). Studies have found that SG has a more manageable safety profile compared to traditional chemotherapy. Patients experienced fewer dose adjustments and quicker relief from side effects with SG.
The most common side effects, such as nausea and fatigue, were manageable and typically mild to moderate, resolving quickly. Overall, the safety of SG aligns with findings from other studies, making it a promising treatment option for consideration.12345Why do researchers think this study treatment might be promising for breast cancer?
Sacituzumab Govitecan is unique because it combines an antibody with a chemotherapy drug, specifically targeting proteins on cancer cells. Unlike standard chemotherapy, which affects both healthy and cancerous cells, this treatment delivers the drug directly to the cancer cells, potentially reducing side effects. Researchers are excited because this targeted approach may lead to more effective treatment for breast cancer, especially in patients who have not responded well to conventional therapies.
What evidence suggests that Sacituzumab Govitecan might be an effective treatment for advanced triple-negative breast cancer?
Research has shown that sacituzumab govitecan (SG) holds promise for treating advanced triple-negative breast cancer (TNBC). Studies have found that SG can slow the disease more effectively than traditional chemotherapy. In earlier trials, patients who received SG lived longer without their cancer worsening, even after trying several other treatments. The drug has also performed well in real-world situations, confirming its potential. Overall, SG has demonstrated a strong ability to help manage advanced TNBC, offering hope for those facing this challenging condition.46789
Are You a Good Fit for This Trial?
Adults with advanced triple-negative breast cancer (TNBC) who haven't had systemic therapy for their advanced condition can join. They must be able to consent, have an ECOG performance status of 0-1, and not be candidates for curative surgery or radiotherapy. Women past childbearing age or willing to use effective contraception may participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sacituzumab Govitecan on days 1 and 8 of 21-day cycles, continuing until disease progression or voluntary withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment, with long-term follow-up every 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Sacituzumab Govitecan
Trial Overview
The trial tests Sacituzumab Govitecan (SG) as a first-line treatment in TNBC patients. It examines if SG slows disease progression and compares its effectiveness between those with HRD subtypes versus non-HRD subtypes of TNBC.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Patients will receive SG at an initial dose of 10 mg per kilogram intravenously on day 1 and 8 of 21-day cycles. Treatment and cycles will continue until there is evidence of disease progression, significant toxicity, or if the participant or Investigator decide to discontinue treatment for any reason.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nathalie Levasseur
Lead Sponsor
British Columbia Cancer Agency
Collaborator
Citations
Sacituzumab Govitecan in Untreated, Advanced Triple- ...
Sacituzumab govitecan led to significantly longer progression-free survival than chemotherapy among patients with advanced triple-negative ...
Real-World Clinical Outcomes With Sacituzumab ...
Our multi-institutional study demonstrates that sacituzumab govitecan is effective in heavily pretreated patients with metastatic triple-negative breast cancer.
ADC Improves Outcomes for Patients with Advanced Triple ...
After a median follow-up of 13.2 months, patients treated with sacituzumab govitecan were more likely to survive longer without disease ...
Effectiveness and safety of sacituzumab govitecan in ...
Conclusions: This real-world study confirms the efficacy and manageable safety profile of SG in heavily pretreated Chinese patients with HER2- ...
Real‐world effectiveness and safety of sacituzumab ...
The phase I/II IMMU-132 trial demonstrated promising results with SG in patients with mTNBC who were refractory to at least two prior lines of ...
The efficacy and safety of sacituzumab govitecan in ...
Conclusions: SG provides substantial clinical benefit in breast cancer, improving ORR, OS, and PFS, particularly in TNBC, with consistent ...
ASCENT-03 Data Show Consistent Safety With ...
Sacituzumab govitecan showed manageable safety vs chemotherapy in first-line TNBC, with fewer dose changes and faster AE resolution.
based therapy in metastatic breast cancer (MBC) in China ...
Clinical outcomes included real-world progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and clinical benefit ...
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cancernursingtoday.com
cancernursingtoday.com/post/sacituzumab-govitecan-as-a-first-line-option-in-metastatic-tnbcSacituzumab Govitecan as a First-Line Option in Metastatic ...
The safety profile of sacituzumab govitecan was consistent with previous studies and generally manageable. Adverse events of any grade occurred ...
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