What is the dose and duration of pembrolizumab (generic name) in the neoadjuvant setting for triple negative breast cancer?

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Last updated: June 20, 2025View editorial policy

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From the Guidelines

Pembrolizumab should be administered at a dose of 200 mg intravenously every 3 weeks for a total of 4-8 cycles in the neoadjuvant setting for triple negative breast cancer (TNBC), in combination with chemotherapy, with a total duration of neoadjuvant treatment of approximately 4-6 months before surgery. The chemotherapy regimens commonly used in combination with pembrolizumab include carboplatin and paclitaxel or anthracycline/cyclophosphamide-based combinations 1. This treatment approach is supported by recent guidelines, which recommend the use of pembrolizumab in combination with chemotherapy for the treatment of TNBC, except for some node-negative special histological subtypes or very low clinical risk tumours 1.

Key Considerations

  • The use of dose-dense schedules of chemotherapy, with granulocyte colony-stimulating factor support, should be considered given their documented benefit over non-dose-dense schedules 1.
  • Patients receiving pembrolizumab should be monitored very closely for the risk of immune-related adverse events throughout treatment and following the ESMO CPG for the management of toxicities from immunotherapy 1.
  • After surgery, patients may continue pembrolizumab as adjuvant therapy for up to one year of total treatment, with a recommended duration of nine 3-week cycles during the adjuvant phase, regardless of pCR status 1.

Treatment Monitoring

  • Regular laboratory monitoring of thyroid function, liver enzymes, and clinical assessment for immune-related toxicities is essential throughout the treatment course.
  • Patients should be monitored for immune-related adverse events during treatment, including thyroid dysfunction, colitis, pneumonitis, and hepatitis.

Recent Study Findings

  • A recent study published in Cancer Treatment Reviews found that the addition of pembrolizumab to neoadjuvant chemotherapy resulted in improved outcomes for patients with TNBC, with a pathological complete response (pCR) rate of 64.8% compared to 51.2% for chemotherapy alone 1.

From the Research

Dose and Duration of Pembrolizumab in Neoadjuvant Setting for Triple Negative Breast Cancer

  • The dose of pembrolizumab used in the neoadjuvant setting for triple negative breast cancer is 200 mg every 3 weeks 2, 3, 4, 5.
  • The duration of pembrolizumab treatment in the neoadjuvant setting is typically 4 cycles, given in combination with chemotherapy such as paclitaxel and carboplatin, followed by 4 cycles of doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide 2, 3, 4, 5.
  • After definitive surgery, patients may receive adjuvant pembrolizumab for up to 9 cycles 2, 3, 4, 5.

Efficacy of Pembrolizumab in Neoadjuvant Setting for Triple Negative Breast Cancer

  • The addition of pembrolizumab to neoadjuvant chemotherapy has been shown to significantly improve pathological complete response and event-free survival in patients with early-stage triple negative breast cancer 2, 3, 4, 5.
  • Pembrolizumab has also been shown to improve overall survival in patients with early-stage triple negative breast cancer 3.

Safety of Pembrolizumab in Neoadjuvant Setting for Triple Negative Breast Cancer

  • The safety profile of pembrolizumab in the neoadjuvant setting for triple negative breast cancer is consistent with the established safety profiles of pembrolizumab and chemotherapy 2, 3, 4, 5.
  • Treatment-related adverse events of grade 3 or higher have been reported in approximately 50-80% of patients receiving pembrolizumab in combination with chemotherapy 2, 3, 4, 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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