Triple Negative Breast Cancer Treated with Neoadjuvant KEYNOTE-522 Immunotherapy + Chemotherapy

Published: 5th March 2025

Request Summary:

Pretreatment (diagnostic) FFPE tumor samples and clinicopathologic data from high-risk early stage Triple-Negative Breast Cancer (TNBC) patients who were treated with one of the following neoadjuvant regimens:

• KEYNOTE-522 regimen: paclitaxel plus carboplatin (4x) followed by doxorubicin or epirubicin plus cyclophosphamide (4x) with pembrolizumab (8x).
• KEYNOTE-522 chemotherapy regimen only: paclitaxel plus carboplatin (4x) followed by doxorubicin or epirubicin plus cyclophosphamide (4x).
• Chemotherapy regimen without platinum: doxorubicin or epirubicin plus cyclophosphamide (4x) followed by paclitaxel (4x).

Clinicopathologic data including demographics, diagnosis, and treatment outcomes (pathologic response, recurrence interval (RFS, DFS)).

Sample Type: FFPE solid tissue tumor blocks

Storage Format: FFPE blocks

Number of Cases: 10 or more. Open to discuss.

Pro/Retrospective: Retrospective

Time Limits: 1-2 months is ideal, but will discuss longer time frame

Inclusion Criteria:

1. Patient is ≥ 18 years old at the time of ICF signature.
2. Patients histologically diagnosed with hormone receptor-negative (defined as ER and PR <10% positive cells assessed by IHC) and HER2-negative early breast cancer.
3. Patients received neoadjuvant therapy (chemotherapy with or without immunotherapy).

Exclusion Criteria:

1. Patients with a known second primary malignancy.
2. Patients with missing pCR AND RFS data.
3. Age under 18 years

Clinical Data Required:

Pathology report, treatment received, outcome including pathologic response and recurrence interval. More detailed CRF will be provided on request.

Destination Country: Slovakia

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updated 09.05.25

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