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New treatment option for Anatomic Stage II Breast Cancer AJCC v8
Official title Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
ClinicalTrials.gov ID: NCT05812807
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage ii breast cancer ajcc v8.
Also referred to as Keytruda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery.
- Phase 3: a large, late-stage study
- Time commitment: about 27 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Triple Negative Breast Cancer:
- Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of...
- Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma...
You likely can't join if
- 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...
- No medical conditions that require chronic systemic steroids (\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive...
See the full eligibility criteria
Who can join
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Triple Negative Breast Cancer:
- Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis according to the primary tumor-regional lymph node anatomic...
- 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...
- Estrogen receptor (ER) and progesterone receptor (PR) =\< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence...
- 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 must 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, however, it is recommended to complete adjuvant...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- Patients with known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
What rules you out
- 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...
- 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...
- Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Goodyear, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Fayetteville, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Arroyo Grande, California, United States
- Berkeley, California, United States
- Beverly Hills, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Chico, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
+ 598 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 27 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Kingman, Arizona, United States and 612 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.