Nab-paclitaxel + Alpelisib for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well nab-paclitaxel and alpelisib works in treating patients with triple negative breast cancer with PIK3CA or PTEN alterations that does not respond to anthracycline chemotherapy (anthrocycline refractory). Drugs used in chemotherapy, such as nab-paclitaxel, 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. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nab-paclitaxel and alpelisib before surgery may help shrink the tumor before surgery.
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 exclude patients using certain strong inhibitors or inducers of the enzyme CYP3A within 5 days before starting the study. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is the combination of Nab-paclitaxel and Alpelisib safe for humans?
Nab-paclitaxel, a key component of the treatment, is generally considered safe and is used in treating various cancers, including breast cancer, without needing premedication to prevent allergic reactions. It has been shown to cause mild to moderate nerve-related side effects in some patients, but severe reactions are rare.12345
What makes the drug Nab-paclitaxel + Alpelisib unique for treating triple-negative breast cancer?
Nab-paclitaxel is a unique form of paclitaxel that uses albumin nanoparticles to deliver the drug more effectively, potentially enhancing its activity and reducing toxicity. This combination with Alpelisib, which targets specific cancer cell pathways, offers a novel approach for treating triple-negative breast cancer, a condition with limited treatment options.16789
What data supports the effectiveness of the drug Nab-paclitaxel + Alpelisib for Triple Negative Breast Cancer?
Research shows that nanoparticle albumin-bound paclitaxel (nab-paclitaxel) can enhance the activity and reduce the toxicity of cancer treatments, and it has shown effectiveness in breast and pancreatic cancers. This suggests that nab-paclitaxel may be a promising component in treating aggressive forms of breast cancer, like triple-negative breast cancer.137910
Who Is on the Research Team?
Senthilkumar Damodaran
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with triple-negative breast cancer that hasn't responded to anthracycline chemo. They must have specific genetic changes (PIK3CA or PTEN), good organ function, no severe diabetes, and not be pregnant. Contraception is required during the study. People with certain heart conditions, uncontrolled diseases, or a history of non-compliance are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alpelisib orally once daily and nab-paclitaxel intravenously over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles.
Surgery
Patients may undergo surgery to remove the tumor after completion of study treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up at 30 days and periodically up to 3 years after surgery.
What Are the Treatments Tested in This Trial?
Interventions
- Alpelisib
- Nab-paclitaxel
Alpelisib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator