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PI3K Inhibitor
Nab-paclitaxel + Alpelisib for Triple Negative Breast Cancer
Phase 2
Waitlist Available
Led By Senthilkumar Damodaran
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 x ULN or and/or creatinine clearance > 50% lower limit of normal (LLN)
Male/ female sterilization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study Summary
This trial is studying nab-paclitaxel and alpelisib to see how well they work in treating triple negative breast cancer that does not respond to anthrocycline chemotherapy.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests nab-paclitaxel combined with alpelisib in patients whose cancer didn't shrink after anthracycline chemotherapy. The goal is to see if this combo can reduce tumor size before surgery by blocking enzymes needed for cell growth and stopping tumor cells from dividing or spreading.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, low blood counts leading to increased infection risk, fatigue, digestive issues like nausea and diarrhea, high blood sugar levels especially in diabetics, skin rash or itching due to allergies to medication components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function tests are within normal limits.
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I have undergone sterilization.
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I use barrier methods like condoms or diaphragms with spermicide for birth control.
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I am fully active or can carry out light work.
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My breast cancer is triple-negative.
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My cancer has specific genetic changes identified by advanced testing.
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My blood sugar and HbA1c levels are within normal ranges.
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My tumor is at least 1 cm or my lymph nodes are involved after chemotherapy.
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My cancer did not respond well to initial chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of minimal residual disease (RCB-I)
Rate of pathological complete response (pCR/RCB-0)
Secondary outcome measures
Incidence of adverse events
Progression free survival
Radiographic response rate (partial response + complete clinical response)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (alpelisib, nab-paclitaxel)Experimental Treatment2 Interventions
Patients receive alpelisib PO QD on days 1-21, and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo surgery to remove the tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
FDA approved
Albumin human
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,675 Previous Clinical Trials
40,926,969 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,975 Previous Clinical Trials
1,789,511 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Senthilkumar DamodaranPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
1,179 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not needed IV antibiotics for an infection in the last 2 weeks.I don't have any neurological conditions that could affect nerve damage assessment.You are currently using another type of cancer treatment.My kidney function tests are within normal limits.I have undergone sterilization.I use barrier methods like condoms or diaphragms with spermicide for birth control.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have heart rhythm problems that are not well-controlled.I have type II diabetes, diagnosed or uncontrolled, confirmed by blood tests.You have shingles caused by the varicella-zoster virus.You have a current, active case of hepatitis B or C.I do not have any serious illnesses or active infections.I have a cytomegalovirus infection.My cancer has spread to distant parts of my body, not just nearby lymph nodes.I am fully active or can carry out light work.My breast cancer is triple-negative.Your white blood cell count is at least 1.5 billion per liter.I have unstable chest pain.I am HIV positive.I have pre-diabetes and follow ADA lifestyle guidelines.I've had at least one dose of anthracycline-based therapy but stopped due to side effects or cancer progression.I have a stomach or intestine problem that affects how I absorb medication.My breast cancer is at an early to mid-stage (I-III).I finished my anthracycline-based therapy 2-5 weeks ago and am starting treatment with alpelisib and nab-paclitaxel.You are not using any drugs or alcohol.My cancer has specific genetic changes identified by advanced testing.I am a man and will use contraception during and 4 weeks after the study if my partner can become pregnant.I haven't taken strong drugs affecting liver enzymes in the last 5 days.I have had radiation therapy on my breast or nearby lymph nodes.My blood sugar and HbA1c levels are within normal ranges.I have mild to severe numbness, tingling, or pain in my hands or feet.I am not pregnant and will use two effective birth control methods if I can become pregnant.You are allergic to alpelisib or any of the ingredients in it.Your heart's electrical activity, called QT interval, is too long.I have had acute pancreatitis within the last year or have chronic pancreatitis.My side effects from the last chemotherapy are mild, except for hair loss.I haven't had blood clotting or bleeding disorders in the last 6 months.I have a history of lung inflammation or scarring.Before joining the ARTEMIS trial, you must have a heart scan (MUGA) or echocardiogram showing that your heart is pumping well.I've been cancer-free for 3 years, except for non-serious skin cancer or certain early-stage cancers.Your fasting serum lipase level is within the normal range.I have not had a heart attack in the last 6 months.I have severe liver problems or cirrhosis.I do not have any major heart conditions.Your total bilirubin level in the blood is less than or equal to 1.5 mg/dL.My heart condition does not severely limit my daily activities.I have a severe narrowing of the main heart valve.I have not had a stroke in the past 6 months.My tumor is at least 1 cm or my lymph nodes are involved after chemotherapy.Your liver enzymes (ALT and AST) and bilirubin levels need to be within a certain range, unless you have Gilbert's syndrome and your direct bilirubin is normal.Your hemoglobin level is higher than 9 grams per deciliter.My cancer did not respond well to initial chemotherapy.I have a serious blood vessel condition like an aortic aneurysm.Your platelet count is at least 100 billion per liter.I have diabetes or diabetes caused by steroids.My high blood pressure is not under control.Your fasting serum amylase level is not more than twice the upper limit of normal.I have serious blood vessel problems in my arms or legs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (alpelisib, nab-paclitaxel)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any harmful side-effects associated with Treatment (alpelisib, nab-paclitaxel)?
"Although there is some evidence suggesting this combination treatment (alpelisib, nab-paclitaxel) is safe, as it is only a Phase 2 trial, more research needs to be done to support its efficacy."
Answered by AI
How many people are being granted access to this research?
"Unfortunately, this particular trial is no longer looking for patients. The listing was created on February 5th, 2020 and edited November 1st, 2022. However, there are 4770 other trials actively recruiting patients with triple negative breast neoplasms and 930 studies for Treatment (alpelisib, nab-paclitaxel) searching for participants right now."
Answered by AI
Are new participants currently being sought for this clinical trial?
"The information available on clinicaltrials.gov suggests that this particular trial is not presently recruiting patients for participation. Although, as of 11/1/2022, it was the most recent date that the study was edited, it was originally posted on 2/5/2020. There are other 5700 trials actively recruiting patients at this time."
Answered by AI
How is the Treatment (alpelisib, nab-paclitaxel) most commonly used?
"Alpelisib and nab-paclitaxel, which are administered together as a treatment, are typically used to combat hypoalbuminemia. However, this combination therapy can also be effective in treating apn, shock, hypovolemic, and locally advanced non-small cell lung cancer."
Answered by AI
Are there any other ongoing research projects that are looking at the efficacy of this proposed combination therapy?
"There are 930 clinical trials being conducted that research the efficacy of alpelisib and nab-paclitaxel. Of these active studies, 243 are in Phase 3. Many of these studies originate from Shanghai, but there are 47327 locations running similar trials across the globe."
Answered by AI
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