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Early-Stage TNBC

CE / CME

Evolving Treatment Landscape for Early-Stage TNBC With and Without gBRCAm

Physician Assistants/Physician Associates: 0.50 AAPA Category 1 CME credit

Pharmacists: 0.50 contact hour (0.05 CEUs)

ABIM MOC: maximum of 0.50 Medical Knowledge MOC point

Physicians: maximum of 0.50 AMA PRA Category 1 Credit™

Nurse Practitioners/Nurses: 0.50 Nursing contact hour

Released: June 26, 2026

Expiration: December 25, 2026

Kristen D. Whitaker
Kristen D. Whitaker, MD, MS
CME/CE Information

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Considerations in the Treatment of Early-Stage TNBC

Treatment selection for early-stage TNBC is often individualized based on tumor size, nodal status, germline BRCA1/2 mutation status, pathologic response after neoadjuvant therapy, prior treatment exposure, and patient comorbidities and preferences.

For patients with smaller node-negative tumors, particularly T1a/bN0 disease, surgery is generally the first step, followed by consideration of adjuvant chemotherapy based on tumor size and other risk features.9 For patients with T1cN0 disease, systemic chemotherapy is highly recommended, although timing (pre or post surgery) may be individualized. Some patients may receive neoadjuvant therapy, whereas others may proceed to surgery followed by adjuvant treatment. Chemotherapy approaches in this lower-stage setting may include docetaxel with cyclophosphamide, a taxane agent with platinum-based therapy, or an anthracycline-containing regimen in selected patients.

For patients with stage II/III TNBC, neoadjuvant systemic therapy is generally preferred. This approach provides early treatment of micrometastatic disease, allows assessment of pathologic response, and helps guide postneoadjuvant treatment decisions. For patients who meet KEYNOTE-522 clinical trial criteria, neoadjuvant carboplatin with paclitaxel followed by anthracycline with cyclophosphamide and pembrolizumab, then followed by surgery and adjuvant pembrolizumab, is recommended.9

The pathologic response after neoadjuvant therapy is one of the most important factors for guiding postoperative management. Patients who achieve pCR after neoadjuvant chemoimmunotherapy generally complete the planned adjuvant pembrolizumab course when following the KEYNOTE-522 regimen. For patients with residual invasive disease, additional postneoadjuvant therapy options may be considered based on prior treatment exposure, germline BRCA1/2 mutation status, residual disease burden, toxicity profile, and patient goals.

For patients with germline BRCA1/2-mutated, HER2-negative, high-risk EBC who meet OlympiA eligibility criteria, 1 year of adjuvant olaparib should be considered. For patients without a germline BRCA1/2 pathogenic variant, adjuvant capecitabine remains a relevant option for selected patients with residual TNBC after neoadjuvant chemotherapy, supported by results from pivotal CREATE-X trial.20 However, the decision to pursue capecitabine should be individualized in the context of modern perioperative treatment, including whether the patient received pembrolizumab, whether residual disease remains after surgery, and whether other postneoadjuvant approaches or clinical trials are appropriate.

The clinical context has become more complex because KEYNOTE-522, CREATE-X, and OlympiA evaluated different populations and treatment strategies. Randomized comparative data do not fully define the optimal sequencing or combination of adjuvant pembrolizumab, capecitabine, and olaparib in all clinical scenarios. Treatment selection should account for recurrence risk, prior pembrolizumab exposure, germline BRCA1/2 status, residual disease burden, toxicity profile, comorbidities, monitoring feasibility, access, and patient preferences.

Shared decision-making is especially important in the postneoadjuvant setting, where some patients may have more than one reasonable treatment path. Discussions should clearly explain the rationale for each option, the expected benefit, limitations of available evidence, treatment duration, toxicity risks, monitoring requirements, and logistical burden. This type of structured conversation can help align treatment selection with both clinical risk and patient priorities.

Several ongoing studies are now addressing the next major questions in early-stage TNBC: whether treatment can be safely de-escalated for patients who achieve pCR and whether therapy should be intensified for patients with residual disease after neoadjuvant treatment. These trials may help clarify how to reduce unnecessary treatment exposure for some patients while improving outcomes for those who remain at higher risk.

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