Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/16/23. Questions regarding updates should be directed to the study team contact.