Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Apr 12, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether the immunotherapy drug pembrolizumab is more effective than simply observing patients after surgery for early-stage triple-negative breast cancer. The trial focuses on patients who have had a complete response to chemotherapy and pembrolizumab before surgery, meaning no signs of cancer were found after treatment. Researchers want to see if using pembrolizumab after surgery can lower the chance of cancer returning compared to just keeping an eye on the patients.
To be eligible for this trial, participants must be at least 18 years old and diagnosed with early-stage triple-negative breast cancer. They should have completed their chemotherapy and surgery with no remaining invasive cancer in their breast or lymph nodes. Participants can expect to be randomly assigned to receive either pembrolizumab or just regular follow-up care. It's important to know that those who have had severe reactions to pembrolizumab in the past or have certain medical conditions may not qualify for the study. Overall, this trial aims to find out the best way to help prevent cancer from coming back after initial treatment.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age \>= 18 years
- • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- * Triple Negative Breast Cancer:
- • Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both
- • Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative
- • Estrogen (ER) and progesterone (PR) =\< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry \[IHC\] and fluorescence in situ hybridization \[FISH\])
- • If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
- • Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively
- • An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization
- • \* Note: Adjuvant radiation can be given on study. If given, it is encouraged to be given concurrently with pembrolizumab, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks post-surgery and must be completed prior to registration
- • Use of investigational anti-cancer agents must be discontinued at time of registration
- * Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
- • Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision
- • \*\* For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
- * Lymph node surgery:
- • For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative
- • For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required
- • \*\*\* If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible
- • If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy
- • If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required
- • If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required
- • Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy
- • If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible
- • Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\< 7 days prior to randomization is required
- • Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- • Platelet Count \>= 100,000/mm\^3
- • Estimated glomerular filtration rate (eGFR) \>= 15 mL/min/1.73m\^2
- • Total Bilirubin =\<1.5 x upper limit of normal (ULN)
- • \* Patients with Gilbert's disease with a total bilirubin =\< 2.5 x ULN and direct bilirubin within normal limits are permitted
- • Aspartate aminotransferase (AST) serum aspartate aminotransferase \[SGOT\] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase \[SGPT\] =\< 3 x institutional ULN
- • Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial
- • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
- Exclusion Criteria:
- • No stage IV (metastatic) breast cancer
- • No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed
- • No evidence of recurrent disease following preoperative therapy and surgery
- • No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis
- • No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product
- • \* Note: Prior immune-related adverse events (irAEs) are allowed if they resolved and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE
- • No medical conditions that require chronic systemic steroids (\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
- • Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Covington, Louisiana, United States
Stamford, Connecticut, United States
'Ewa Beach, Hawaii, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Crown Point, Indiana, United States
Dyer, Indiana, United States
Hobart, Indiana, United States
Hobart, Indiana, United States
Indianapolis, Indiana, United States
Munster, Indiana, United States
New Albany, Indiana, United States
Valparaiso, Indiana, United States
Council Bluffs, Iowa, United States
Kalamazoo, Michigan, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Sleepy Hollow, New York, United States
Greensboro, North Carolina, United States
Dublin, Ohio, United States
Chambersburg, Pennsylvania, United States
Baytown, Texas, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
Richardson, Texas, United States
The Woodlands, Texas, United States
Goodyear, Arizona, United States
Frederick, Maryland, United States
Paramus, New Jersey, United States
Glastonbury, Connecticut, United States
Neenah, Wisconsin, United States
New London, Wisconsin, United States
Shawano, Wisconsin, United States
Waupaca, Wisconsin, United States
Ocoee, Florida, United States
New York, New York, United States
Westerly, Rhode Island, United States
Vancouver, Washington, United States
Highlands Ranch, Colorado, United States
Raleigh, North Carolina, United States
Missoula, Montana, United States
Torrance, California, United States
Lone Tree, Colorado, United States
Greenlawn, New York, United States
Oshkosh, Wisconsin, United States
Pierre, South Dakota, United States
Annapolis, Maryland, United States
Cary, North Carolina, United States
Brooklyn, New York, United States
Baton Rouge, Louisiana, United States
'Aiea, Hawaii, United States
Nampa, Idaho, United States
Springfield, Illinois, United States
Asheboro, North Carolina, United States
Perrysburg, Ohio, United States
Santa Monica, California, United States
Denver, Colorado, United States
Aurora, Colorado, United States
Sheboygan, Wisconsin, United States
Meadville, Pennsylvania, United States
Safety Harbor, Florida, United States
Fort Worth, Texas, United States
Berlin, Wisconsin, United States
Mineola, New York, United States
Raleigh, North Carolina, United States
Kansas City, Missouri, United States
Seattle, Washington, United States
Bellevue, Washington, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Dallas, Texas, United States
Lebanon, New Hampshire, United States
Cameron Park, California, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Nampa, Idaho, United States
Grove City, Ohio, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Foxboro, Massachusetts, United States
Dayton, Ohio, United States
Webster, New York, United States
San Juan, , Puerto Rico
Danville, Illinois, United States
Guilford, Connecticut, United States
Orland Park, Illinois, United States
Greenville, Ohio, United States
Decatur, Georgia, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Asheboro, North Carolina, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Woodbridge, Virginia, United States
Lansing, Michigan, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Rockford, Illinois, United States
Hays, Kansas, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Council Bluffs, Iowa, United States
Madison, Wisconsin, United States
Lynchburg, Virginia, United States
Ridgewood, New Jersey, United States
Washington, North Carolina, United States
Kirkland, Washington, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Johnson Creek, Wisconsin, United States
Sandpoint, Idaho, United States
Ontario, Oregon, United States
Irvine, California, United States
Lexington, Kentucky, United States
Hastings, Nebraska, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Crown Point, Indiana, United States
Athens, Ohio, United States
Pickerington, Ohio, United States
Westerville, Ohio, United States
Camillus, New York, United States
Southfield, Michigan, United States
Novi, Michigan, United States
Madison, Wisconsin, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Flint, Michigan, United States
Warren, Michigan, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Olathe, Kansas, United States
Grosse Pointe Woods, Michigan, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Asheboro, North Carolina, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cherry Hill, New Jersey, United States
Kearney, Nebraska, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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