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Chemotherapy
Chemoimmunotherapy for Triple-Negative Breast Cancer (NeoTRACT Trial)
Phase 2
Recruiting
Led By Shane R Stecklein, MD, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines
Histologically confirmed cT1c-T3 cN0-N2 cM0 TNBC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
NeoTRACT Trial Summary
This trial examines if immune cells can help shrink triple-negative breast cancer tumors with chemo and immunotherapy.
Who is the study for?
This trial is for women aged 18-70 with triple-negative breast cancer (TNBC) that hasn't spread beyond the breasts and lymph nodes. Participants must have tumors that are hormone receptor poor, HER2-negative, no prior treatments or surgeries for their current breast cancer, and good heart function. They should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The study tests if immune cells around TNBC affect how well the tumor responds to a combination of chemotherapy drugs (Doxorubicin, Carboplatin, Docetaxel, Cyclophosphamide) plus an immunotherapy drug called Pembrolizumab given before surgery.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medications used; fatigue; hair loss; nausea; increased risk of infections due to lowered white blood cell counts; heart problems from Doxorubicin; nerve damage from Docetaxel.
NeoTRACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My invasive tumor is not HER2 positive according to the latest guidelines.
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My breast cancer is in stages 1C to 3, has possibly spread to nearby lymph nodes but not to distant parts of the body.
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I do not have severe nerve damage.
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I am a woman aged between 18 and 70.
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I haven't received any treatment for my current breast cancer.
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My breast cancer is not driven by hormones.
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I haven't had surgery on the same breast for my current cancer.
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I have given a sample of my breast tumor for testing.
NeoTRACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 in high sTIL cohort with radiographic complete response
Secondary outcome measures
Recurrence-free, event-free, and overall survival
Residual cancer burden (RCB) 0+1 rate in high sTIL cohort with radiographic complete response
pCR and RCB 0+1 in intermediate sTIL cohort
+1 moreNeoTRACT Trial Design
3Treatment groups
Active Control
Group I: High sTILs (≥30%)Active Control3 Interventions
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles.
Group II: Intermediate sTILs (5-29%)Active Control3 Interventions
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for six cycles.
Group III: Low sTILs (<5%)Active Control5 Interventions
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles followed by Doxorubicin (60 mg/m2) + Cyclophosphamide (600 mg/m2) + Pembrolizumab (200 mg) every 14 or 21 days for four cycles.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,068 Total Patients Enrolled
22 Trials studying Breast Cancer
4,371 Patients Enrolled for Breast Cancer
Shane R Stecklein, MD, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping function is normal, as shown by a heart ultrasound or a MUGA scan.My invasive tumor is not HER2 positive according to the latest guidelines.My breast cancer is in stages 1C to 3, has possibly spread to nearby lymph nodes but not to distant parts of the body.I have TNBC in both breasts and meet other study requirements.You have had a very bad allergic reaction to pembrolizumab or any of the substances it contains.I am not pregnant or breastfeeding and, if capable of becoming pregnant, I agree to use contraception during and for 4 months after treatment.I haven't received any treatment for my current breast cancer.My cancer is at stage III and has been checked for spread to other parts.I am a woman aged between 18 and 70.I do not have severe nerve damage.I haven't had a heart attack, stroke, or severe heart issues in the last year and my blood pressure is controlled.I have not received a live vaccine in the last 30 days.I have an immune system disorder or have been on high-dose steroids or other drugs that weaken my immune system recently.My breast cancer is not driven by hormones.My blood, liver, and kidney functions are all within normal ranges.I have had non-infectious lung inflammation treated with steroids in the past year.I have inflammatory breast cancer.I have been diagnosed with HIV.My abnormal lymph nodes were confirmed by a biopsy or fine needle aspiration.I haven't had cancer in the last 5 years, except for certain skin, breast, or cervical cancers treated definitively.I have recovered from any major surgery before starting the study treatment.I am allergic to doxorubicin, cyclophosphamide, carboplatin, or docetaxel.I am currently on medication for an infection.I have had treatment for breast cancer before.My blood, kidney, liver, or heart function is not good.I haven't had surgery on the same breast for my current cancer.My cancer has spread to other parts of my body.I have been treated with specific immune system-targeting drugs before.You have an active hepatitis B or C infection.I have an autoimmune disease treated with strong medication in the last 2 years.I, or my legal representative, can understand the study and agree to sign the consent form.I've had breast and underarm scans within the last 30 days.I have given a sample of my breast tumor for testing.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: High sTILs (≥30%)
- Group 2: Intermediate sTILs (5-29%)
- Group 3: Low sTILs (<5%)
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.
Is the enrollment of participants aged 20 years or older permissible in this experiment?
"According to the criteria outlined in this clinical trial, only patients between 18-70 years old can apply. For those under 18 and over 65 there are still 74 trials and 2570 respectively that they may qualify for."
Answered by AI
What potential health issues can arise from abnormally low sTILs (<5%)?
"The safety of Low sTILs (<5%) was evaluated to be a 2 on the 1-3 scale due to this being a Phase 2 trial, which has limited data backing its efficacy but some for its security."
Answered by AI
How widespread is the deployment of this experiment in North America's healthcare institutions?
"Six sites are currently accepting participants for this clinical trial. Included in the list is The University of Kansas Cancer Center - Overland Park, The University of Kansas Cancer Center - Westwood, and The University of Kansas Cancer Centre- Main Hospital situated in Lee's Summit; furthermore, 3 other healthcare facilities have also been included within the scope."
Answered by AI
Could you explain the recruitment status of this medical experiment?
"Clinicaltrials.gov confirms that this particular medical study is no longer recruiting patients, as the initial posting and last edit were both on December 1st 2022. However, there are still 2664 other trials across all of medicine that are actively seeking participants at present."
Answered by AI
Who can sign up to participate in this investigative research?
"This medical research is in search of 139 volunteers aged between 18 and 70 who have been diagnosed with breast cancer. Furthermore, they must meet the following criteria: capacity to understand this study or their legal representative’s willingness to sign a written informed consent; cT1c-T3 cN0-N2 cM0 TNBC as confirmed histologically; hormone receptor poor (ER and PR staining ≤ 10% by IHC); HER2 negative based on ASCO-CAP guidelines; no previous ipsilateral breast surgery for current breast cancer; no prior chemotherapy, immunotherapy, endocrine therapy or radiotherapy for current"
Answered by AI
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