Chemotherapy Combinations for Triple-Negative Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require stopping sex hormonal therapy like birth control pills before joining. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination for triple-negative breast cancer?
Research shows that adding carboplatin to anthracycline and taxane-based chemotherapy improves the complete response rate in early-stage triple-negative breast cancer, although it may increase side effects. Additionally, paclitaxel combined with other agents has shown significant tumor growth inhibition and reduced metastasis in triple-negative breast cancer.12345
What safety data exists for chemotherapy combinations used in treating triple-negative breast cancer?
Chemotherapy drugs like anthracyclines and taxanes, used in treating triple-negative breast cancer, can have side effects such as cardiotoxicity (heart damage) and other adverse effects like hypersensitivity reactions, low white blood cell counts, nerve damage, and hair loss. However, some newer drugs like DZ-2384 show promise with fewer side effects compared to traditional taxanes.13678
How is the chemotherapy combination of Cyclophosphamide, Doxorubicin Hydrochloride, and Paclitaxel unique for treating triple-negative breast cancer?
This chemotherapy combination is unique because it uses a mix of drugs that are effective in breast cancer treatment, with Cyclophosphamide and Doxorubicin Hydrochloride being part of anthracycline-containing regimens, which are widely used due to their efficacy, and Paclitaxel, a taxane, which is often incorporated for its effectiveness. This combination is part of ongoing efforts to find optimal regimens for triple-negative breast cancer, a type that lacks targeted therapies and relies heavily on chemotherapy.19101112
What is the purpose of this trial?
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Research Team
Vicente Valero
Principal Investigator
NRG Oncology
Eligibility Criteria
This trial is for patients with triple-negative breast cancer who have good blood counts, no metastatic disease on imaging, and a performance status indicating they can care for themselves. They must not be pregnant or breastfeeding, haven't received certain cancer treatments before, and don't have other serious health issues that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Paclitaxel
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator