Shorter Chemo-Immunotherapy for Early-Stage Triple Negative Breast Cancer
This study is comparing two different chemotherapy (chemo)-immunotherapy treatments for early-stage triple negative breast cancer. Researchers want to see if a shorter treatment without anthracycline drugs (like Doxorubicin) is as effective as the usual treatment. The study will look at how well patients respond to treatment and their survival without the cancer returning. You may be able to join if you are 18 or older and have triple negative breast cancer, meaning your cancer is negative for estrogen receptor (ER), progesterone receptor (PR), and HER2. The study aims to enroll 2400 participants. The main goal is to see if the shorter treatment leads to similar breast cancer event-free survival (how long you live without the cancer coming back or getting worse) up to 5 years.
- Study design
- This is a large interventional study planning to enroll 2400 participants. It compares two different treatment approaches for early-stage triple negative breast cancer.
- What's involved
- You would undergo collection of blood samples. The specific schedule of visits, procedures, and tests beyond blood collection is not detailed in the record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for breast cancer event-free survival for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05929768
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentSWOG Cancer Research NetworkGovernment-funded
~2,400 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinCyclophosphamideDocetaxelDoxorubicinPaclitaxel
At a glance
Recruiting sites
923 of 963 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Breast cancer event-free survival (BC-EFS)
Measured over Up to 5 years
Conditions
Where it's being run
963 sites across 50 statesMichigan88
Illinois83
California75
Wisconsin65
Minnesota48
Pennsylvania48
Colorado44
Nevada40
Study leadership
- Priyanka Sharma · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER \< 5%, PR \< 5%, and HER2 negative (per 2020 American Society of Clinical Oncology \[ASCO\] College of American Pathologists \[CAP\] guidelines)
NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician
Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either
T2-T4, N0, M0 or
T1-T3, N1-2, M0
Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status
Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization
Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria
Participants must not have T4/N+, any N3, or inflammatory breast cancer
Participants must not have metastatic disease (M1)
Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer
Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer
Participants must not have current or anticipated use of other investigational agents while participating in this study
Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents
Participants must not have severe hypersensitivity (\>= grade 3) to pembrolizumab or any of its excipients
Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization
Participants must be \>= 18 years old
Participants must have Zubrod performance status of 0-2
Participants with evidence of peripheral neuropathy must have it at =\< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization
Participants must have a complete medical history and physical exam within 28 days prior to randomization
Hemoglobin \>= 9.0 g/dL or \>= 5.6 mol/L (within 28 days prior to randomization)
(Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)
Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to randomization)
Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to randomization)
Platelets \>= 100 x 10\^3/uL (within 28 days prior to randomization)
Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =\< IULN for participants with total bilirubin \> 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional IULN) (within 28 days prior to randomization)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance \>= 50 mL/min/1.73m\^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction \>= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better
Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
Note: No testing for Hepatitis B is required unless mandated by local health authority
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
Note: No testing for hepatitis C is required unless mandated by local health authority
Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator
Participants must not have uncontrolled hypertension in the opinion of the treating investigator
Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator
Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia
Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis
Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed
Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
Participants must have one (1) physical 4-5-micron single hematoxylin and eosin (H\&E) slide from the archival pretreatment diagnostic biopsy available for submission
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
Participants who can complete questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study
NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
As part of the registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
What this trial measures
- Breast cancer event-free survival (BC-EFS)Up to 5 years
Time from randomization to the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. BC-EFS will be compared between the treatment arms using Cox regression with adjustment for nodal status and sTIL enrichment.