START : A randomized phase 2 study in patients with triple-negative, androgen receptor positive locally recurrent (unresectable) or metastatic breast cancer treated with darolutamide or capecitabine
The START clinical trial is testing a new approach for women with advanced triple-negative breast cancer that also has 'androgen receptors'. Androgen receptors are proteins on cancer cells that react to certain hormones. Standard treatment often involves chemotherapy tablets called capecitabine. This study compares capecitabine directly with darolutamide, a hormone-blocking tablet commonly used in other cancers. Researchers want to find out whether darolutamide works as well as, or better than, standard chemotherapy. Participants are randomly placed into one of two groups to take either darolutamide or capecitabine at home. Doctors will monitor each person's progress closely using regular scans and health checks to see whether tumours shrink or stay stable at 16 weeks and beyond. The findings could give patients with this specific breast cancer an effective alternative to traditional chemotherapy.
At a glance
What is this study about?
Breast cancers are grouped into different types depending on specific proteins, called receptors, found on the cancer cells. One less common type is called 'triple-negative' breast cancer that also tests positive for 'androgen receptors'. Androgens are hormones that both men and women make. In this particular subtype of breast cancer, these hormones can act like fuel, encouraging the cancer cells to multiply and spread.
Currently, people with this condition are usually offered chemotherapy, such as a medicine called capecitabine. While chemotherapy can be effective, researchers are keen to find treatments that target the cancer cells more precisely. The START study focuses on a drug called darolutamide (also known as Nubeqa). Darolutamide blocks androgen receptors, which may help cut off the signals telling the cancer cells to grow.
This is a Phase 2 clinical trial. Half of the participants will take darolutamide, and the other half will take capecitabine. The research team wants to measure the 'clinical benefit rate' at 16 weeks. This simply means checking what proportion of patients see their tumours shrink or stay completely stable without getting worse.
By taking part, patients help doctors understand whether hormone-blocking tablets are a safe and effective alternative to chemotherapy for this specific form of breast cancer, potentially offering a different range of side effects and improving quality of life.
Key takeaways
- Compares a targeted hormone-blocker (darolutamide) against standard chemotherapy tablets (capecitabine).
- Open to women with advanced triple-negative, androgen-receptor-positive breast cancer.
- All participants receive an active treatment; no dummy pills (placebos) are used.
- The main goal is to measure tumour control and stability after 16 weeks of treatment.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is designed for adult women aged 18 and older who have advanced breast cancer. Specifically, your cancer must be triple-negative (meaning it lacks oestrogen, progesterone, and HER2 receptors) but positive for androgen receptors. Your hospital care team will check this by testing a small sample of tumour tissue.
To be considered, your cancer must either be locally recurrent (meaning it has returned in the breast or chest area and cannot be removed with surgery) or metastatic (meaning it has spread to other parts of the body).
Because your safety is the top priority, you will also need to have reasonably good general health, including satisfactory liver, kidney, and bone marrow function. Your doctor will review your medical history and current health to confirm if this trial is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a woman aged 18 or older.
- I have been diagnosed with triple-negative breast cancer.
- My tumour has tested positive for androgen receptors.
- My cancer has spread to other parts of the body or cannot be removed by surgery.
- I am well enough to manage day-to-day activities and take tablets by mouth.
What does participation involve?
If you take part, a computer will randomly choose whether you receive darolutamide or capecitabine. Both medications are tablets that you swallow at home. You will visit the hospital regularly for health checks, blood tests, and scans (such as CT scans) to see how well the treatment is working and to monitor any side effects. Doctors will formally evaluate your cancer at 16 weeks and 24 weeks, and you can stay on your assigned treatment for as long as it continues to help you and side effects remain manageable. The study team will follow up on your health for up to two years.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
Will I receive a placebo (dummy pill)?
No. There is no placebo in this study. Every participant receives an active cancer medicine—either darolutamide or capecitabine.
Can I pick which medicine I take?
No. A computer randomly decides which treatment you receive. This ensures the trial results are completely unbiased and scientifically fair.
How do I take the study treatments?
Both darolutamide and capecitabine are taken as tablets by mouth at home, following the specific dosing instructions given by your trial doctor.
What happens if my cancer grows during the study?
Your scans will be checked regularly. If the scans show your cancer is growing, or if you feel unwell, the study treatment will be stopped and your doctor will discuss other treatment options with you.
Will taking part cost me anything?
No. The study drugs and extra tests are provided free of charge, and many clinical trials offer help with travel expenses to and from the hospital.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.