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Alkylating agents

Chemotherapy for Triple Negative Breast Cancer

Phase 2
Waitlist Available
Led By Kent Hoskins, M.D.
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 28 days prior to study registration
Must not have
Pre-existing neuropathy from any cause in excess of Grade 1
Major surgery within 14 days prior to registration or has not recovered from major side effects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat Triple Negative Breast Cancer.

Who is the study for?
This trial is for women over 18 with Triple Negative Breast Cancer (TNBC) that hasn't been treated before. They must not be pregnant or breastfeeding and willing to use two birth control methods. Participants should have a life expectancy of at least 6 months, an ECOG performance status of 0-2, and adequate organ function. The cancer must be operable, and they can't have had certain treatments or conditions that would affect the trial.
What is being tested?
The study tests weekly Carboplatin plus Paclitaxel followed by Doxorubicin and Cyclophosphamide in patients with TNBC before surgery. It's a Phase 2 nonrandomized trial where all participants receive the same treatment sequence to see how effective it is in treating their breast cancer.
What are the potential side effects?
Possible side effects include allergic reactions to drugs, fatigue, hair loss from chemotherapy (Doxorubicin), bone marrow suppression leading to low blood cell counts, risk of infection due to weakened immune system, nausea, vomiting, nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is triple-negative.
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I can care for myself and am up and about more than 50% of my waking hours.
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My breast cancer was confirmed with a needle or incisional biopsy.
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I am planning to have surgery to remove my breast tumor and check the nearby lymph nodes after chemotherapy.
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My breast cancer is at an early stage but may have spread to nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have mild or no nerve damage.
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I haven't had major surgery in the last 2 weeks or still have major side effects from it.
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I do not have any severe health issues that could make this trial unsafe for me.
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I have not had a stroke or mini-stroke in the last 6 months.
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I don't have any other cancers that could affect this treatment's safety or results.
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I have a known history of AIDS.
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I have been treated with carboplatin, paclitaxel, doxorubicin, or cyclophosphamide in the last 3 years.
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I am currently on hormone replacement therapy or taking drugs like tamoxifen.
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I haven't taken any experimental drugs recently.
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I am currently on medication for an infection.
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I have had treatment aimed at curing my current breast cancer.
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I have heart failure or my heart's pumping ability is below 50%.
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I don't have serious heart rhythm problems or I have a pacemaker.
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I have had myelodysplastic syndrome or acute myeloid leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathological complete response (pCR) rate
Secondary study objectives
Breast conservation rate
Clinical response to neoadjuvant chemotherapy
Distant disease-free survival (DDFS)
+7 more

Awards & Highlights

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: Single armExperimental Treatment4 Interventions
Low dose weekly carboplatin in combination with standard neoadjuvant chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5450
Doxorubicin
2012
Completed Phase 3
~8030
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,773 Total Patients Enrolled
12 Trials studying Breast Cancer
1,342,384 Patients Enrolled for Breast Cancer
Kent Hoskins, M.D.Principal InvestigatorUniversity of Illinois at Chicago
1 Previous Clinical Trials
960 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04083963 — Phase 2
Breast Cancer Research Study Groups: Single arm
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04083963 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083963 — Phase 2
~3 spots leftby Sep 2026
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