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Alkylating agents

Chemotherapy for Triple Negative Breast Cancer

Phase 2

Waitlist Available

Led By Kim Hirshfield

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not exhibit a non-healing wound or any skin breakdown

Women with previously untreated, unilateral stage II-III breast cancer, ER/PgR/HER2 negative

Must not have

Specific cardiac conditions

Definitive clinical or radiologic evidence of metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from initiation of chemotherapy until death from any cause, assessed up to 20 yearsup to 20 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new combination chemotherapy treatment for breast cancer patients with no estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein (triple negative).

Who is the study for?

This trial is for women with previously untreated stage II-III triple-negative breast cancer who are expected to live more than a year and can undergo surgery. They must have good performance status, satisfactory blood counts, normal heart function, and agree to use contraception. Excluded are those with certain cardiac conditions, serious disorders, inflammatory breast cancer, severe lung or nervous system issues, history of major organ transplant or need for immunosuppression.

What is being tested?

The study tests if pegylated liposomal doxorubicin hydrochloride and carboplatin chemotherapy before surgery followed by paclitaxel after surgery can effectively treat patients with triple-negative breast cancer. The treatment aims to shrink tumors pre-surgery and eliminate remaining cells post-surgery.

What are the potential side effects?

Possible side effects include fatigue, nausea, hair loss from chemotherapy; surgical complications like infection; heart problems due to doxorubicin; nerve damage from paclitaxel; allergic reactions to drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any non-healing wounds or skin issues.

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I have stage II-III breast cancer that is ER, PgR, and HER2 negative.

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I am eligible for surgery to treat my breast cancer.

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I can do all or most of my daily activities without help.

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My life expectancy is at least one year, not counting my breast cancer.

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My heart functions normally according to tests.

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I can provide tumor samples from my biopsy and breast surgery.

Exclusion Criteria

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

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I have a heart condition.

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My cancer has spread to other parts of my body.

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I have been diagnosed with inflammatory breast cancer.

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I am not pregnant or breastfeeding.

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I have a lung condition that makes it hard for me to breathe.

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I have a moderate to severe nervous system disorder.

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I have had an organ transplant or need medicine to suppress my immune system.

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I have symptoms of poor blood flow in my limbs.

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I have been treated with specific medications for cancer before.

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I have serious blood vessel problems.

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I have hepatitis B or C with abnormal liver tests.

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I cannot take corticosteroids due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from initiation of chemotherapy until death from any cause, assessed up to 20 yearsup to 20 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from initiation of chemotherapy until death from any cause, assessed up to 20 yearsup to 20 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from initiation of chemotherapy until death from any cause, assessed up to 20 yearsup to 20 years 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 Pathologic Complete Response (pCR) Based on Response Evaluation Criteria in Solid Tumors Criteria

Secondary study objectives

Mutational Spectrum of Tumors

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 (doxil, carboplatin, surgery, paclitaxel)Experimental Treatment7 Interventions

NEOADJUVANT: Patients receive pegylated liposomal doxorubicin hydrochloride\* IV over 90 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. ADJUVANT: Patients undergo definitive surgery at the discretion of the treating physician. Patients then receive paclitaxel IV over 60 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. \*NOTE: If there is a shortage of pegylated liposomal doxorubicin hydrochloride, patients receive epirubicin hydrochloride IV over 15-20 minutes on day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

FDA approved

Doxorubicin

FDA approved

Carboplatin

FDA approved

therapeutic conventional surgery

2003