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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response (pCR) rate
Secondary outcome measures
Breast conservation rate
Clinical response to neoadjuvant chemotherapy
Distant disease-free survival (DDFS)
+7 moreTrial 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
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,342 Total Patients Enrolled
11 Trials studying Breast Cancer
1,342,356 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild or no nerve damage.I haven't had major surgery in the last 2 weeks or still have major side effects from it.My breast cancer is triple-negative.I don't have any other cancers that could affect this treatment's safety or results.I do not have any severe health issues that could make this trial unsafe for me.I haven't had a heart attack or heart inflammation in the last 6 months.I am willing to use two effective birth control methods.I have not had a stroke or mini-stroke in the last 6 months.I have a known history of AIDS.I can care for myself and am up and about more than 50% of my waking hours.My breast cancer was confirmed with a needle or incisional biopsy.I am planning to have surgery to remove my breast tumor and check the nearby lymph nodes after chemotherapy.My recent tests show my organs are functioning well.Your doctor thinks you will live for at least 6 more months.I have been treated with carboplatin, paclitaxel, doxorubicin, or cyclophosphamide in the last 3 years.I have had a seizure in the last 6 months.I am currently on hormone replacement therapy or taking drugs like tamoxifen.I haven't taken any experimental drugs recently.I am currently on medication for an infection.I have had treatment aimed at curing my current breast cancer.I am a woman aged 18 or older.My breast cancer is at an early stage but may have spread to nearby lymph nodes.I have heart failure or my heart's pumping ability is below 50%.I don't have serious heart rhythm problems or I have a pacemaker.I understand and can follow the study's procedures.I have had myelodysplastic syndrome or acute myeloid leukemia.I have not had any major abdominal issues like a fistula, perforation, or abscess in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 vacancies left for participation in this clinical investigation?
"The records available on clinicaltrials.gov indicate that this medical trial is not presently enrolling patients; it was initially posted in August 2019 and last updated January 28th 2022. Despite the cessation of recruitment for this specific study, there are still over 4,300 other trials accepting new participants at present."
Answered by AI
What is the cap on participants for this research endeavor?
"At present, the trial has ceased recruiting new candidates. Initially posted on August 9th 2019 and last updated on January 28th 2022, this investigation is no longer accepting participants. However, there are 2351 studies for breast cancer currently open to enrollees and 1975 trials involving this treatment still admitting patients."
Answered by AI
What is the typical application of this therapeutic procedure?
"This therapeutic intervention is typically used to facilitate remission in patients with lymphoma, non-Hodgkin's. It additionally has been proven effective at treating a variety of other conditions such as leukemia, Kaposi's Sarcoma related to AIDS and locally advanced Non-Small cell lung cancer (NSCLC)."
Answered by AI
Does this trial represent a pioneering venture in its field?
"Since 1997, this therapeutic intervention has been subject to medical experimentation. Initially sponsored by Alfacell, the first trial enrolled 300 patients and eventually led to Phase 3 drug approval. At present, there are 1975 active trials for this treatment across 85 countries in 3800 cities."
Answered by AI
Has the FDA certified this particular therapy?
"With Phase 2 data backing its safety but no evidence of efficacy, we give this medication a score of 2."
Answered by AI
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