Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Launched by SWOG CANCER RESEARCH NETWORK · Jun 26, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a shorter course of chemotherapy combined with immunotherapy, without using a specific type of drug called anthracyclines, is just as effective as the usual treatment for early-stage triple-negative breast cancer. Triple-negative breast cancer is a type of cancer that does not have certain hormone receptors, making it more challenging to treat. The goal is to see if this new approach can effectively control the cancer while potentially causing fewer side effects.
To participate in this trial, individuals must be adults aged 18 or older with confirmed triple-negative breast cancer that meets specific criteria regarding the stage and characteristics of the disease. Participants should not have received previous treatments for their current cancer and should meet certain health requirements. Those who join the study will receive the new treatment regimen and be closely monitored by healthcare professionals throughout the trial. It's important to note that participants will need to provide consent and may also have the opportunity to contribute samples for further research.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Flint, Michigan, United States
Denver, Colorado, United States
Flint, Michigan, United States
Edina, Minnesota, United States
Waconia, Minnesota, United States
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Clarkston, Michigan, United States
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East China Township, Michigan, United States
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Flint, Michigan, United States
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Grosse Pointe Woods, Michigan, United States
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Pontiac, Michigan, United States
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Saginaw, Michigan, United States
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Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
West Branch, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
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Ontario, Oregon, United States
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Anchorage, Alaska, United States
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Anchorage, Alaska, United States
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Creston, Iowa, United States
Bardstown, Kentucky, United States
Corbin, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
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Yelm, Washington, United States
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O'fallon, Illinois, United States
Yorkville, Illinois, United States
Brighton, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Ypsilanti, Michigan, United States
Maple Grove, Minnesota, United States
Wyoming, Minnesota, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Sunset Hills, Missouri, United States
Asheville, North Carolina, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Findlay, Ohio, United States
Findlay, Ohio, United States
Franklin, Ohio, United States
Greenville, Ohio, United States
Clackamas, Oregon, United States
Seattle, Washington, United States
Denver, Colorado, United States
Monticello, Minnesota, United States
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Oxford, Mississippi, United States
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London, Kentucky, United States
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Midlothian, Virginia, United States
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San Luis Obispo, California, United States
Santa Maria, California, United States
Woodland, California, United States
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Royal Oak, Michigan, United States
Royal Oak, Michigan, United States
Sterling Heights, Michigan, United States
Troy, Michigan, United States
Troy, Michigan, United States
Seattle, Washington, United States
Dekalb, Illinois, United States
Beavercreek, Ohio, United States
Stevens Point, Wisconsin, United States
Bayamon, , Puerto Rico
Manati, , Puerto Rico
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Collegeville, Pennsylvania, United States
Exton, Pennsylvania, United States
Hazleton, Pennsylvania, United States
Collierville, Tennessee, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Golden, Colorado, United States
Thornton, Colorado, United States
Royal Oak, Michigan, United States
Worthington, Minnesota, United States
Clyde, North Carolina, United States
Redmond, Oregon, United States
Royal Oak, Michigan, United States
Mechanicsville, Virginia, United States
Lake Forest, Illinois, United States
Fargo, North Dakota, United States
Chadds Ford, Pennsylvania, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
San Mateo, California, United States
Santa Rosa, California, United States
Tarzana, California, United States
Colorado Springs, Colorado, United States
Frankford, Delaware, United States
Peabody, Massachusetts, United States
Burnsville, Minnesota, United States
Richmond, Virginia, United States
San Juan, , Puerto Rico
Golden, Colorado, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Carmichael, California, United States
Thief River Falls, Minnesota, United States
Weaverville, North Carolina, United States
Midlothian, Virginia, United States
Vancouver, Washington, United States
Torrance, California, United States
Little Rock, Arkansas, United States
Napa, California, United States
Newtown Square, Pennsylvania, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Lexington, Kentucky, United States
Valley Stream, New York, United States
Des Moines, Iowa, United States
Mount Sterling, Kentucky, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Centralia, Illinois, United States
Dayton, Ohio, United States
Richmond, Virginia, United States
San Juan, , Puerto Rico
Danville, Illinois, United States
Orland Park, Illinois, United States
Osage Beach, Missouri, United States
Patients applied
Trial Officials
Priyanka Sharma
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported