Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
This research study is investigating the best way to treat a specific type of breast cancer called triple-negative breast cancer. After surgery, patients typically receive a chemotherapy combination of doxorubicin hydrochloride, cyclophosphamide, and paclitaxel. This study aims to find out if adding another chemotherapy drug, carboplatin, to this standard treatment makes it more effective. The study compares giving the standard drugs followed by paclitaxel alone versus paclitaxel plus carboplatin. Researchers want to see if the addition of carboplatin can better prevent the cancer from coming back or spreading, ultimately improving a patient's chances of recovery and survival. This is a Phase 3 trial, meaning it's a large study designed to confirm the effectiveness and safety of the new approach.
At a glance
What is this study about?
This study is for people in the UK who have been diagnosed with a specific type of breast cancer called triple-negative breast cancer. You might have heard your doctors refer to your cancer as 'triple-negative' if it doesn't respond to typical hormone-based treatments or treatments that target a protein called HER2. This means the usual types of breast cancer treatments might not work for you, and doctors are always looking for better ways to treat it.
The main idea behind this study is to see if adding an extra chemotherapy drug, called carboplatin, to a standard chemotherapy treatment helps prevent triple-negative breast cancer from coming back after surgery. Standard treatment often involves a combination of drugs like doxorubicin hydrochloride, cyclophosphamide, and paclitaxel. The study wants to compare patients who receive the standard drugs followed by paclitaxel alone, with those who receive the standard drugs followed by paclitaxel plus carboplatin. They are trying to find out which approach leads to better long-term results, like keeping the cancer away for longer.
Chemotherapy drugs work in various ways to fight cancer cells, for example, by killing them, stopping them from growing, or preventing them from spreading. By carefully comparing these treatment approaches, doctors hope to learn if adding carboplatin offers a real benefit for people with triple-negative breast cancer. This kind of research is vital because it helps doctors develop the most effective treatments for different types of cancer, ultimately improving the care that patients receive.
Key takeaways
- Targets triple-negative breast cancer after surgery.
- Compares standard chemotherapy with and without carboplatin.
- Aims to improve outcomes and prevent cancer recurrence.
- Involves chemotherapy infusions and regular follow-up.
- Patients are randomly assigned to one of two treatment groups.
- Participation allows potential access to a new treatment approach and close medical monitoring.
Who may be eligible?
To join this study, your doctor will need to check several things to make sure the study is right for you and that the results will be clear. You would need to have been diagnosed with a specific type of breast cancer called 'triple-negative breast cancer'. This means your cancer cells don't have certain features (estrogen receptors, progesterone receptors, or HER2 protein) that other breast cancers might have.
Your cancer must be an 'invasive adenocarcinoma' and be at certain stages (IB, IIA, IIB, IIIA, or IIIC). You must have had surgery for your breast cancer, either a mastectomy (removal of the whole breast) or a lumpectomy (removal of the lump). If you had a lumpectomy, the edges of the removed tissue must be free of cancer cells.
Other important checks include your general health and how well you can carry out daily activities. You must be aged 18 or older. Your medical team will go through all the detailed requirements with you to see if you meet the specific criteria for this research.
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.
- Have you been diagnosed with triple-negative breast cancer?
- Has your breast cancer been surgically removed (mastectomy or lumpectomy)?
- Are you 18 years of age or older?
- Is your general health good enough to undergo chemotherapy (as determined by your doctor)?
- Have your doctors confirmed your cancer is at a specific stage (IB, IIA, IIB, IIIA, or IIIC)?
What does participation involve?
If you decide to take part in this study, you would be assigned by chance to one of two treatment groups. Both groups will receive chemotherapy drugs, which involve regular visits to the hospital for infusions. You would have a series of chemotherapy treatments, typically starting with doxorubicin hydrochloride and cyclophosphamide, followed by paclitaxel. One group will also receive carboplatin alongside paclitaxel.
Throughout the study, you will have various tests, including blood tests and scans, to keep a close eye on your health and how the treatment is working. Your doctors and nurses will monitor you for any side effects. After your main chemotherapy treatment is completed, you will have regular follow-up appointments over several years to check your long-term health and scan for any signs of the cancer returning. The total duration of active treatment is usually several months, but follow-up checks can continue for five years or more. All aspects of your participation will be fully explained before you agree to join.
Potential risks and benefits
Locations (1296)
- Southern Cancer Center PC-MobileVerified postcodeMobile, United States
- Southern Cancer Center PC-ProvidenceVerified postcodeMobile, United States
- Southern Cancer Center PC-SpringhillVerified postcodeMobile, United States
- Anchorage Associates in Radiation MedicineVerified postcodeAnchorage, United States
- Anchorage Radiation Therapy CenterVerified postcodeAnchorage, United States
- Alaska Breast Care and Surgery LLCVerified postcodeAnchorage, United States
- Alaska Oncology and Hematology LLCVerified postcodeAnchorage, United States
- Alaska Regional HospitalVerified postcodeAnchorage, United States
- Alaska Women's Cancer CareVerified postcodeAnchorage, United States
- Anchorage Oncology CentreVerified postcodeAnchorage, United States
- Katmai Oncology GroupVerified postcodeAnchorage, United States
- Providence Alaska Medical CenterVerified postcodeAnchorage, United States
Common questions
What is 'triple-negative breast cancer'?
It's a type of breast cancer where the cancer cells don't have certain features (estrogen or progesterone receptors, or too much HER2 protein) that are common in other breast cancers. This means different treatments are needed.
Why is this study being done?
Doctors want to find out if adding an extra chemotherapy drug called carboplatin to standard treatment for triple-negative breast cancer can improve how well the treatment works and help prevent the cancer from coming back.
What are 'Phase 3' trials?
Phase 3 trials are large studies that compare a new treatment or a new combination of existing treatments against the best current standard treatment. They are designed to confirm if a new approach is better and safer.
Will I definitely get the new drug?
Because this is a trial comparing two approaches, you would be randomly assigned to one of two groups. One group gets the standard treatment plus carboplatin, and the other gets the standard treatment alone. Neither you nor your doctor can choose which group you are in.
What happens if I change my mind about participating?
You are free to leave the study at any time, for any reason, without it affecting your medical care. Your doctors will discuss all your options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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