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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

Must not have

Patient has diagnosis of stage IV disease or is found to have stage IV disease prior to initiation of chemotherapy

Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is at stage IV.

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I cannot receive chemotherapy with taxane or anthracycline.

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I have previously received chemotherapy or immunotherapy.

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I have moderate to severe nerve damage.

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My physical activity is limited due to my health condition.

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I had surgery to remove a sample of my breast cancer.

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I have not had severe heart failure or a heart attack in the last 6 months.

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I have had serious heart problems.

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I have a history of heart rhythm problems.

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I have changes in my tumor area that may affect imaging results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Frequency of tumors

Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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