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Purpose <p>Hormone receptor-positive (HR+), HER2-negative breast cancer represents the most common subtype of breast cancer and is characterized by a risk of late recurrence. Neoadjuvant endocrine therapy with aromatase inhibitors (AIs) is a well-tolerated option in postmenopausal women; however, strategies to enhance its efficacy are needed. Combination of AI with immunotherapy is a promising approach. We evaluated the efficacy and safety of combining an AI with the anti-program death ligand 1 antibody durvalumab in the neoadjuvant setting.</p> Methods <p>This single-arm, phase II study used a Simon two-stage design. Postmenopausal patients with early-stage HR+/HER2-negative breast cancer received durvalumab every 4&#xa0;weeks plus daily AI for 6&#xa0;months prior to surgery. The primary endpoint was the achievement of a modified Preoperative Endocrine Prognostic Index (mPEPI) score of 0.</p> Results <p>Seventeen patients were enrolled and received durvalumab plus daily AI for six months before surgery. Treatment was well tolerated, with most adverse events being grade 1–2. A clinical complete response was seen in 58.8% of patients, although no pathologic complete responses occurred. Among the first 14 patients, one achieved mPEPI 0, which did not meet criteria to proceed to stage two. Overall, three patients (17.6%) achieved mPEPI 0.</p> Conclusion <p>Neoadjuvant durvalumab plus AI was safe but demonstrated limited pathologic efficacy in this unselected HR + HER2-negative population. Favorable long-term outcomes support further investigation of immunoendocrine combinations in HR + HER2-negative breast cancer in biomarker-selected subgroups.</p> Trial registration <p>NCT03874325. <i>Date of registration</i>. 12-03-2019.</p>

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Neoadjuvant therapy with an aromatase inhibitor and durvalumab in postmenopausal patients with hormone receptor-positive breast cancer

  • 期刊论文

  • 发表日期：

    2026年2月16日

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  • Aixa E. Soyano Muller,
  • Dawn N. Goodridge,
  • Qianxing Mo,
  • Junmin Whiting,
  • Nazanin Khakpour,
  • Marie Catherine Lee,
  • Christine Laronga,
  • Avan J. Armaghani,
  • Hyo Han,
  • Hatem Soliman,
  • Ricardo Costa,
  • Loretta Loftus,
  • Susan J. Hoover,
  • John V. Kiluk,
  • Zena Jameel,
  • Brian J. Czerniecki,
  • Hung T. Khong

摘要

Purpose

Hormone receptor-positive (HR+), HER2-negative breast cancer represents the most common subtype of breast cancer and is characterized by a risk of late recurrence. Neoadjuvant endocrine therapy with aromatase inhibitors (AIs) is a well-tolerated option in postmenopausal women; however, strategies to enhance its efficacy are needed. Combination of AI with immunotherapy is a promising approach. We evaluated the efficacy and safety of combining an AI with the anti-program death ligand 1 antibody durvalumab in the neoadjuvant setting.

Methods

This single-arm, phase II study used a Simon two-stage design. Postmenopausal patients with early-stage HR+/HER2-negative breast cancer received durvalumab every 4 weeks plus daily AI for 6 months prior to surgery. The primary endpoint was the achievement of a modified Preoperative Endocrine Prognostic Index (mPEPI) score of 0.

Results

Seventeen patients were enrolled and received durvalumab plus daily AI for six months before surgery. Treatment was well tolerated, with most adverse events being grade 1–2. A clinical complete response was seen in 58.8% of patients, although no pathologic complete responses occurred. Among the first 14 patients, one achieved mPEPI 0, which did not meet criteria to proceed to stage two. Overall, three patients (17.6%) achieved mPEPI 0.

Conclusion

Neoadjuvant durvalumab plus AI was safe but demonstrated limited pathologic efficacy in this unselected HR + HER2-negative population. Favorable long-term outcomes support further investigation of immunoendocrine combinations in HR + HER2-negative breast cancer in biomarker-selected subgroups.

Trial registration

NCT03874325. Date of registration. 12-03-2019.