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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

Must not have

History of neurological conditions that would confound assessment of treatment-emergent neuropathy

Prior history of hypertensive crisis or hypertensive encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any neurological conditions that could affect nerve damage assessment.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I have heart rhythm problems that are not well-controlled.

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I have type II diabetes, diagnosed or uncontrolled, confirmed by blood tests.

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I have a cytomegalovirus infection.

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I have unstable chest pain.

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I am HIV positive.

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I have a stomach or intestine problem that affects how I absorb medication.

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I am a man and will use contraception during and 4 weeks after the study if my partner can become pregnant.

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I have had radiation therapy on my breast or nearby lymph nodes.

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I have mild to severe numbness, tingling, or pain in my hands or feet.

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I have had acute pancreatitis within the last year or have chronic pancreatitis.

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I have a history of lung inflammation or scarring.

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I have severe liver problems or cirrhosis.

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I do not have any major heart conditions.

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My heart condition does not severely limit my daily activities.

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I have a severe narrowing of the main heart valve.

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I have not had a stroke in the past 6 months.

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I have a serious blood vessel condition like an aortic aneurysm.

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I have diabetes or diabetes caused by steroids.

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My high blood pressure is not under control.

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I have serious blood vessel problems in my arms or legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of minimal residual disease (RCB-I)

Rate of pathological complete response (pCR/RCB-0)

Secondary study objectives

Incidence of adverse events

Progression free survival

Radiographic response rate (partial response + complete clinical response)

Awards & Highlights

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 31Eligibility criteria met