Sacituzumab Govitecan for Breast Cancer
(SERIES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the medication sacituzumab govitecan, an antibody-drug conjugate, can effectively treat metastatic breast cancer that is hormone receptor positive (HR+) with low levels of human epidermal growth factor 2 (HER2 low). The focus is on patients who have already tried trastuzumab deruxtecan. It suits individuals with advanced breast cancer who have experienced disease progression after previous treatments, including trastuzumab deruxtecan. Participants will receive the medication through an IV infusion every 21 days until the disease progresses or side effects become unacceptable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) for some treatments before starting the study. For example, hormonal therapy and immunotherapy need a 2-week washout period, and T-DXd requires a 3-week washout period. The protocol does not specify if you need to stop all current medications, so it's best to discuss your specific situation with the study team.
Is there any evidence suggesting that sacituzumab govitecan is likely to be safe for humans?
Research has shown that sacituzumab govitecan (SG) is generally safe for patients with breast cancer. Studies have provided extensive information about its safety. Common side effects include nausea, hair loss, and low blood cell counts, but these are usually manageable. The FDA has already approved the drug for treating certain types of breast cancer, indicating that its safety is well-understood. Overall, while side effects can occur, they are often mild to moderate and can be controlled with proper care.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 chemotherapy drug, creating a targeted treatment for breast cancer. Unlike standard chemotherapy, which can affect both healthy and cancerous cells, sacituzumab govitecan specifically targets the Trop-2 protein commonly found on the surface of cancer cells. This targeted approach aims to deliver the chemotherapy directly to the cancer cells, potentially reducing side effects and improving effectiveness. Researchers are excited about its potential to offer a more precise treatment option with possibly better outcomes for patients.
What evidence suggests that sacituzumab govitecan might be an effective treatment for breast cancer?
Research has shown that sacituzumab govitecan (SG) is effective in treating certain breast cancers, particularly in patients with advanced triple-negative breast cancer. One study found that SG reduced the risk of cancer progression or death by 38% compared to standard chemotherapy. Another study reported that patients treated with SG lived an average of 12.1 months, significantly longer than the 6.7 months for those receiving standard treatment. Although SG is currently approved for advanced HR+/HER2 negative breast cancer, this trial tests its effectiveness in patients previously treated with trastuzumab deruxtecan. Positive results in similar cases suggest it might also be effective in this new context.15678
Who Is on the Research Team?
Reshma Mahtani, DO
Principal Investigator
Miami Cancer Institute at Baptist Health, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with metastatic, hormone receptor positive (HR+)/HER2 low breast cancer who have previously been treated with trastuzumab deruxtecan. Participants must meet specific health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sacituzumab govitecan (SG) on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity
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:
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease
- Locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor
- Unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reshma L. Mahtani, D.O.
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