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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Pathologic Complete Response (pCR) Based on Response Evaluation Criteria in Solid Tumors Criteria

Secondary outcome measures

Mutational Spectrum of Tumors

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

Completed Phase 3

~12270

Paclitaxel

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,170 Total Patients Enrolled

16 Trials studying Breast Cancer

1,910 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,091 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Rutgers Cancer Institute of New JerseyOTHER

70 Previous Clinical Trials

18,695 Total Patients Enrolled

8 Trials studying Breast Cancer

1,923 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02315196 — Phase 2

Breast Cancer Research Study Groups: Treatment (doxil, carboplatin, surgery, paclitaxel)

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02315196 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02315196 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is the combination of doxil, carboplatin, surgery and paclitaxel typically used to aid patients?

"Doxil, carboplatin, surgery and paclitaxel are frequently used to manage lymphoma and non-Hodgkin's diseases. These treatments can also be applied in the treatment of conditions like corticotropin, Kaposi's sarcoma AIDS related, and locally advanced non-small cell lung cancer."

Answered by AI

What are the potential risks associated with utilizing doxil, carboplatin, surgery and paclitaxel for treatment?

"Our team at Power bestows a safety score of 2 upon this particular treatment (doxil, carboplatin, surgery, paclitaxel) due to limited efficacy data and extant evidence attesting to its security."

Answered by AI

How many participants are benefitting from the current research trial?

"This clinical trial is currently not enrolling, having been last updated on March 28th 2023. Those searching for other studies may find 2386 trials actively recruiting patients with breast cancer and 1380 involving doxil, carboplatin, surgery or paclitaxel treatments that are still open to participants."

Answered by AI

Is this a newly implemented trial?

"Since 1997, when the Alfacell Corporation initiated its first clinical trial involving 300 patients, Treatment (doxil, carboplatin, surgery and paclitaxel) has been subject to extensive research. It was officially given Phase 3 drug approval following that initial study. Presently there are 1,380 active trials examining this treatment in 86 nations across 3641 cities worldwide."

Answered by AI

Are there still openings for prospective participants in this clinical trial?

"At this time, no further participants are being accepted for the trial. Initially posted on February 25th 2015 and lastly updated March 28th 2023, alternative trials with similar aims can be found; 2386 actively recruiting studies concerning breast cancer and 1380 investigating Treatment (doxil, carboplatin, surgery, paclitaxel) have openings."

Answered by AI

What aims is this research endeavor hoping to achieve?

"This trial will be assessing pathologic complete response (pCR) rates as its chief outcome. Secondary objectives include analyzing mutational spectrum of tumors though Cox model analysis, monitoring recurrence-free survival with the Kaplan-Meier method, and utilizing quality of life surveys to assess patient wellbeing. All tests shall occur at a significance level of 5%. By evaluating these outcomes between mutation status groups over time intervals ranging from 28 days to 28 weeks post baseline evaluation it is hoped that this research can determine which tumours are most susceptible to targeted agents or combination therapies and also understand any additive/synergistic effects they may have on patients' health stat"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer

Deborah Toppmeyer, MD 2015. "Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02315196.

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