Study Information for Participants: Investigating a potential new treatment for those with advance or metastatic cancer.
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to evaluate the safety and efficacy of an investigational medication that has the potential to help people with advanced or metastatic breast cancer. This study will include the evaluation of the safety and efficacy of an investigational treatment (DB-1303) compared to a control treatment (one of three types of single-agent chemotherapy, chosen by the study doctor) in treating metastatic breast cancer that has progressed despite endocrine therapy.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
Queensland
- Mater Hospital Brisbane -
Mater Research Level 3, Aubigny Place, Raymond Terrace, South Brisbane, 4101.
South Australia
- GenesisCare St Andrews Hospital -
Level 1/337 South Tce, Adelaide SA, 5000
Who can participate?
To take part in this study, you will need to meet all the following (other criteria apply):
- Adults (≥ 18 years of age)
- Advanced or metastatic breast cancer
- HER2-low or HR positive breast cancer
- No prior chemotherapy for advanced or metastatic breast cancer
Please note, additional eligibility criteria apply.
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- Have other ongoing uncontrolled illnesses
- Have a past medical history of significant cardiovascular disease
- Previous treatment with anti-HER2 therapy
- Previous treatment with chemotherapy for metastatic breast cancer
Please note, additional eligibility criteria apply and will be discussed in a phone call
with our team.
What is involved?
The total duration of this study is not fixed and will vary depending on the number of treatment cycles with the investigational product or control treatment. This includes:
- Tissue screening to determine eligibility.
- One clinic visit for a physical screening.
- If eligible, you will be randomised to receive either the investigational treatment (DB-1303) or a control treatment (one of three types of single-agent chemotherapy, chosen by the study doctor). You will be informed which treatment you are assigned to. Treatment cycles last 3-4 weeks, with no fixed number of cycles.
- End of treatment visit within 7 days after discontinuing study treatment.
- Safety follow-up visit approximately 35 days after your last dose.
- Long-term follow-up visits every 3 months.
Participation in this research is voluntary, and you may withdraw from the study at any time.
Your participation in this research study has the potential to advance our understanding of medical science, lead to improved treatments, and deliver better health outcomes.
If you take part in the research study, there will be:
- Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
- Free study-related medical care: Be among the first to access potential research treatments before they are widely available
- Expert medical monitoring: Receive top-tier medical care and monitoring from experienced healthcare professionals.
- Contribution to medical research: Help researchers investigate a potential treatment that could improve the lives of individuals with advanced or metastatic breast cancer.
What is HER2-low and HR-positive metastatic breast cancer?
HER2-low (Human epidermal growth factor receptor 2 low) and HR-positive (Human receptor-positive) refer to the subtype of cancer a person has, as determined by microscopy. This type of breast cancer is driven by hormones and has spread beyond the breast to other parts of the body.
This combination of HER2-low and HR-positive breast cancer can influence treatment options, as it may respond differently to certain therapies compared to other types of breast cancer.
Why is this study important?
This study is important because it focuses on a specific type of breast cancer called HER2-low breast cancer. Until recently, patients with HER2-low breast cancer were treated the same way as those with HER2-negative breast cancer, but emerging research shows that this group may respond differently to certain treatments.
Currently, after trying hormone therapies and targeted therapies, patients whose cancer keeps progressing often turn to chemotherapy, which is associated with adverse events such as nausea, vomiting, alopecia, and skin reactions. There is a need for treatments that offer better benefits with fewer risks for this group of patients who receive chemotherapy after hormone therapy.
Who is involved?
This study is being sponsored by Duality Biologics - a clinical stage company committed to discovering and developing antibody-drug conjugate (ADC) agents to treat cancer and autoimmune-related illnesses.
FOR MORE INFORMATION OR TO REGISTER YOUR INTEREST, VISIT TRIALS.EVRIMA.COM
This trial has been approved by an independent ethics committee
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
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