Chemotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on warfarin, you must have a stable dose with an INR of 3 or less and no active bleeding.
Is chemotherapy for breast cancer generally safe for humans?
Chemotherapy treatments like doxorubicin and paclitaxel have been studied for safety, with some reports of cardiac (heart-related) side effects, especially when used together. However, limiting the dose of doxorubicin can help manage these risks, and ongoing studies are exploring ways to reduce cardiac toxicity further. Other side effects of paclitaxel include allergic reactions, low white blood cell counts, nerve damage, and hair loss.12345
How is the chemotherapy drug combination of Cyclophosphamide, Doxorubicin Hydrochloride, and Paclitaxel unique for breast cancer treatment?
This chemotherapy drug combination is unique because it uses both anthracyclines (like Doxorubicin) and taxanes (like Paclitaxel) in a sequential regimen, which is a common and effective approach for reducing cancer recurrence in breast cancer patients. The combination is well-established for its safety and efficacy, providing a balance between effectiveness and manageable side effects.678910
What evidence supports the effectiveness of the drug combination used in the chemotherapy for breast cancer trial?
Research shows that combining paclitaxel and doxorubicin is highly effective in treating advanced breast cancer, with manageable side effects. Additionally, Abraxane and cyclophosphamide have shown better outcomes in recurrent breast cancer compared to other therapies, suggesting the potential effectiveness of this drug combination.1112131415
Who Is on the Research Team?
William M Sikov
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for patients with breast cancer that can be surgically removed. They must have hormone receptor-poor tumors, no significant bleeding or heart issues in the past 6 months, and normal organ function tests. Pregnant women are excluded, as are those who've had prior treatments for this cancer. Participants need to agree to biopsies and use non-hormonal contraception if applicable.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive paclitaxel weekly for 12 weeks, followed by dose-dense doxorubicin and cyclophosphamide every 2 weeks for 4 cycles
Surgery
Definitive surgery, either modified radical mastectomy or breast-conserving surgery, is performed 4-8 weeks after completion of neoadjuvant therapy
Follow-up
Participants are monitored for safety, effectiveness, and recurrence-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- 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?
National Cancer Institute (NCI)
Lead Sponsor