To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.
Participants must be 18 years of age or older, able to understand and give written informed consent.
Histologically proven TNBC, defined as ER ≤10%, PR ≤10%, and HER2 negative based on the 2023 ASCO/CAP guidelines.
Clinical stage T1cN1-2 or T2-4N0-2 TNBC according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition.
Medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed.
History of other malignancies within the last 5 years except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above.
Prior excisional biopsy of the primary invasive breast cancer.
Single group
Paclitaxel + Carboplatin
DrugGiven by IV
Pembrolizumab
DrugGiven by IV
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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This trial is not recruiting at the moment. You can still explore other options:
