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Chemotherapy
Chemotherapy for Triple-Negative Breast Cancer
N/A
Recruiting
Led By Clinton Yam
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (< 10% tumor staining) and negative for HER2 (immunohistochemistry [IHC] score < 3, gene copy number not amplified)
Creatinine within 1.5 X the upper limits of normal OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether a new algorithm that looks at the genomic signature of each patient's tumor can predict their sensitivity to standard of care treatment or if they would respond better to a personally designed treatment trial.
Who is the study for?
This trial is for patients with newly diagnosed Stage I-III triple-negative breast cancer who can undergo biopsy or surgery. They must have adequate blood counts, organ function, and be eligible to receive specific chemotherapy regimens. Those with stage IV disease, prior invasive cancer treatments within 5 years (except certain skin cancers), poor performance status, heart issues, severe neuropathy or conditions affecting tumor assessment by imaging are excluded.Check my eligibility
What is being tested?
The study tests a new algorithm predicting treatment response in triple-negative breast cancer using genomic signatures of tumors. It compares standard care with personalized trials based on protein testing and lymphocyte infiltration analysis to see if tailored treatments improve tumor response.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy and immunotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, potential allergic reactions and possible heart complications among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple-negative, not showing positive for ER, PR, or HER2.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I cannot receive immunotherapy with certain chemotherapies due to medical reasons.
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I am medically cleared to receive immunotherapy with chemotherapy.
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
Response rate
Secondary outcome measures
Frequency of tumors
Survival
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (predictive results given)Experimental Treatment5 Interventions
Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy with immunotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype
Group II: Arm B (predictive results given)Experimental Treatment4 Interventions
Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, and after 4 cycles of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.
Group III: Arm A (predictive results given)Experimental Treatment4 Interventions
Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 cycles, after 4 cycles of treatment, and after completion of treatment (before surgery). Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Lymph Node Biopsy
2014
Completed Phase 2
~50
Ultrasonography
2013
Completed Phase 4
~4320
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,788,321 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,006 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Clinton YamPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is at stage IV.I haven't had invasive cancer in the last 5 years, except for treated skin cancer.I have previously received chemotherapy or immunotherapy.I had surgery to remove a sample of my breast cancer.My kidney function, measured by creatinine levels or clearance, is within the required range.I cannot receive immunotherapy with certain chemotherapies due to medical reasons.I cannot receive chemotherapy with taxane or anthracycline.I have moderate to severe nerve damage.My physical activity is limited due to my health condition.I have not had severe heart failure or a heart attack in the last 6 months.I have had serious heart problems.I have a history of heart rhythm problems.I am eligible for a biopsy or surgery for my stage I to III breast cancer and will receive specific chemotherapy.My breast cancer is triple-negative, not showing positive for ER, PR, or HER2.My heart pumps well, as shown by a recent heart scan.I have changes in my tumor area that may affect imaging results.I am medically cleared to receive immunotherapy with chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (predictive results given)
- Group 2: Arm C (predictive results given)
- Group 3: Arm A (predictive results given)
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.
How many individuals have enrolled in this trial thus far?
"Affirmative. According to clinicaltrials.gov, the investigation has been actively recruiting since November 9th 2015 and is currently looking for 1000 patients across 5 locations. The project was last updated on May 3rd 2022."
Answered by AI
Is admission for this medical trial still available?
"According to the clinicaltrials.gov registry, this research endeavour is currently in need of volunteers; it was published back on November 9th 2015 and underwent its latest revision on May 3rd 2022."
Answered by AI
Where are the sites providing access to this research?
"This clinical trial is being conducted in 5 different sites, with the M D Anderson Cancer Center in Houston and MD Anderson West Houston located in Sugar Land as two of them. Additionally, there are 3 other places where this study is running."
Answered by AI
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