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Search / Trial NCT05929768

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 23, 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.

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

Peoria, Illinois, United States

Anchorage, Alaska, United States

Oklahoma City, Oklahoma, United States

Great Falls, Montana, United States

Saint Paul, Minnesota, United States

Chanute, Kansas, United States

Dodge City, Kansas, United States

Newton, Kansas, United States

Wellington, Kansas, United States

Winfield, Kansas, United States

Jackson, Mississippi, United States

Bozeman, Montana, United States

Kalispell, Montana, United States

Sheridan, Wyoming, United States

Cincinnati, Ohio, United States

Lewes, Delaware, United States

Mount Vernon, Illinois, United States

Salina, Kansas, United States

Gresham, Oregon, United States

Tualatin, Oregon, United States

Bryn Mawr, Pennsylvania, United States

Salina, Kansas, United States

Coon Rapids, Minnesota, United States

Urbana, Illinois, United States

Wichita, Kansas, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Shakopee, Minnesota, United States

Willmar, Minnesota, United States

Council Bluffs, Iowa, United States

Dayton, Ohio, United States

Effingham, Illinois, United States

Independence, Kansas, United States

Lawrence, Kansas, United States

Saint Joseph, Missouri, United States

Greenville, Ohio, United States

Bethlehem, Pennsylvania, United States

Longmont, Colorado, United States

Springfield, Illinois, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

Roseville, California, United States

Springfield, Illinois, United States

Media, Pennsylvania, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

Modesto, California, United States

Saint Louis, Missouri, United States

Kearney, Nebraska, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Wynnewood, Pennsylvania, United States

Mountain View, California, United States

Newark, Delaware, United States

Aurora, Illinois, United States

Kettering, Ohio, United States

Allentown, Pennsylvania, United States

Centralia, Washington, United States

Providence, Rhode Island, United States

Cape Girardeau, Missouri, United States

Coos Bay, Oregon, United States

Novato, California, United States

Pueblo, Colorado, United States

New Orleans, Louisiana, United States

Fridley, Minnesota, United States

Robbinsdale, Minnesota, United States

Saint Louis Park, Minnesota, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Memphis, Tennessee, United States

San Juan, , Puerto Rico

Beverly Hills, California, United States

Omaha, Nebraska, United States

Glens Falls, New York, United States

Royal Oak, Michigan, United States

Stony Brook, New York, United States

Sioux Falls, South Dakota, United States

Sacramento, California, United States

Detroit, Michigan, United States

Saint Louis, Missouri, United States

Marshfield, Wisconsin, United States

Portland, Oregon, United States

Mcpherson, Kansas, United States

Decatur, Illinois, United States

Ottawa, Illinois, United States

Peoria, Illinois, United States

El Dorado, Kansas, United States

Kingman, Kansas, United States

Parsons, Kansas, United States

Pratt, Kansas, United States

Wichita, Kansas, United States

Beverly, Massachusetts, United States

Gloucester, Massachusetts, United States

Missoula, Montana, United States

Galesburg, Illinois, United States

Cedar Rapids, Iowa, United States

Cedar Rapids, Iowa, United States

Clive, Iowa, United States

Des Moines, Iowa, United States

Lansing, Michigan, United States

Warren, Michigan, United States

Lincoln, Nebraska, United States

Papillion, Nebraska, United States

Anchorage, Alaska, United States

Omaha, Nebraska, United States

Palm Springs, California, United States

Los Angeles, California, United States

Cape Girardeau, Missouri, United States

Peru, Illinois, United States

Adrian, Michigan, United States

Monroe, Michigan, United States

Pontiac, Michigan, United States

Maplewood, Minnesota, United States

Maplewood, Minnesota, United States

Stillwater, Minnesota, United States

Great Falls, Montana, United States

Findlay, Ohio, United States

Maumee, Ohio, United States

Toledo, Ohio, United States

Thomasville, Georgia, United States

Bremerton, Washington, United States

Paoli, Pennsylvania, United States

Burbank, California, United States

Alton, Illinois, United States

Galesburg, Illinois, United States

Richmond, Indiana, United States

Kansas City, Kansas, United States

Topeka, Kansas, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Elkton, Maryland, United States

Dearborn, Michigan, United States

Saginaw, Michigan, United States

Bemidji, Minnesota, United States

Woodbury, Minnesota, United States

Joplin, Missouri, United States

Kansas City, Missouri, United States

Springfield, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Missoula, Montana, United States

Pinehurst, North Carolina, United States

Boardman, Ohio, United States

Dayton, Ohio, United States

Franklin, Ohio, United States

Troy, Ohio, United States

Warren, Ohio, United States

Youngstown, Ohio, United States

Portland, Oregon, United States

East Stroudsburg, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Richmond, Virginia, United States

Vancouver, Washington, United States

Minocqua, Wisconsin, United States

Rice Lake, Wisconsin, United States

Weston, Wisconsin, United States

Kettering, Ohio, United States

Berkeley, California, United States

Mountain View, California, United States

Palo Alto, California, United States

San Francisco, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Lakewood, Colorado, United States

Wheat Ridge, Colorado, United States

Burlington, Massachusetts, United States

Bellingham, Washington, United States

Livonia, Michigan, United States

Kennewick, Washington, United States

Sedro Woolley, Washington, United States

Clackamas, Oregon, United States

Newberg, Oregon, United States

Littleton, Colorado, United States

New Ulm, Minnesota, United States

Boise, Idaho, United States

Castro Valley, California, United States

Lakeland, Florida, United States

Hendersonville, North Carolina, United States

Canton, Illinois, United States

Carthage, Illinois, United States

Eureka, Illinois, United States

Kewanee, Illinois, United States

Macomb, Illinois, United States

Peru, Illinois, United States

Princeton, Illinois, United States

Boise, Idaho, United States

Rockford, Illinois, United States

Parker, Colorado, United States

Warrenville, Illinois, United States

Joplin, Missouri, United States

Walla Walla, Washington, United States

Greenville, South Carolina, United States

Fort Smith, Arkansas, United States

Santa Rosa, California, United States

Vallejo, California, United States

Post Falls, Idaho, United States

Bloomington, Illinois, United States

Geneva, Illinois, United States

Pekin, Illinois, United States

Hays, Kansas, United States

Liberal, Kansas, United States

Bolivar, Missouri, United States

Branson, Missouri, United States

Saint Louis, Missouri, United States

Bend, Oregon, United States

Boiling Springs, South Carolina, United States

Easley, South Carolina, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Greer, South Carolina, United States

Seneca, South Carolina, United States

San Juan, , Puerto Rico

Auburn, California, United States

Cameron Park, California, United States

Carmichael, California, United States

Roseville, California, United States

Santa Rosa, California, United States

Olathe, Kansas, United States

Jefferson City, Missouri, United States

Omaha, Nebraska, United States

Hendersonville, North Carolina, United States

Oklahoma City, Oklahoma, United States

Longview, Washington, United States

Jonesboro, Arkansas, United States

Sunnyvale, California, United States

Fruitland, Idaho, United States

Meridian, Idaho, United States

Nampa, Idaho, United States

Twin Falls, Idaho, United States

Farmington Hills, Michigan, United States

Rolla, Missouri, United States

Rolla, Missouri, United States

Fargo, North Dakota, United States

Oregon City, Oregon, United States

Edmonds, Washington, United States

Everett, Washington, United States

Issaquah, Washington, United States

Lacey, Washington, United States

Vancouver, Washington, United States

New Richmond, Wisconsin, United States

Springfield, Illinois, United States

West Columbia, South Carolina, United States

Anchorage, Alaska, United States

Auburn, California, United States

Davis, California, United States

Santa Cruz, California, United States

Newark, Delaware, United States

Newark, Delaware, United States

Newark, Delaware, United States

Rehoboth Beach, Delaware, United States

Wilmington, Delaware, United States

Caldwell, Idaho, United States

Coeur D'alene, Idaho, United States

Emmett, Idaho, United States

Meridian, Idaho, United States

Sandpoint, Idaho, United States

Clive, Iowa, United States

West Des Moines, Iowa, United States

Garden City, Kansas, United States

Great Bend, Kansas, United States

Manhattan, Kansas, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Caro, Michigan, United States

Chelsea, Michigan, United States

Clarkston, Michigan, United States

Clarkston, Michigan, United States

East China Township, Michigan, United States

Flint, Michigan, United States

Flint, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Grosse Pointe Woods, Michigan, United States

Macomb, Michigan, United States

Marlette, Michigan, United States

Pontiac, Michigan, United States

Pontiac, Michigan, United States

Pontiac, Michigan, United States

Saginaw, Michigan, United States

Sterling Heights, Michigan, United States

Warren, Michigan, United States

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

Anaconda, Montana, United States

Centerville, Ohio, United States

Baker City, Oregon, United States

Ontario, Oregon, United States

Cody, Wyoming, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Anchorage, Alaska, United States

Colorado Springs, Colorado, United States

Durango, Colorado, United States

Durango, Colorado, United States

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

Aberdeen, Washington, United States

Seattle, Washington, United States

Shelton, Washington, United States

Yelm, Washington, United States

Carbondale, Illinois, United States

Carterville, Illinois, United States

Centralia, Illinois, United States

Decatur, Illinois, United States

Effingham, Illinois, United States

Mattoon, Illinois, United States

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

Columbus, Mississippi, United States

Grenada, Mississippi, United States

New Albany, Mississippi, United States

Oxford, Mississippi, United States

Southhaven, Mississippi, United States

Eau Claire, Wisconsin, United States

Fremont, California, United States

London, Kentucky, United States

Winchester, Massachusetts, United States

Midlothian, Virginia, United States

Phoenix, Arizona, United States

Elk Grove, California, United States

Rocklin, California, United States

Sacramento, California, United States

San Luis Obispo, California, United States

Santa Maria, California, United States

Woodland, California, United States

Tawas City, Michigan, United States

Royal Oak, Michigan, United States

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

Arroyo Grande, California, United States

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

0 patients applied

Trial Officials

Priyanka Sharma

Principal Investigator

SWOG Cancer Research Network

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported