Sherene Loi, Roberto Salgado, Giuseppe Curigliano, et al. Nat Med. 2025 Feb;31(2):433-441
We conducted a randomized, multicenter, double-blind phase 3 trial to investigate the benefit of adding nivolumab to neoadjuvant chemotherapy in patients with newly diagnosed, high-risk, grade 3 or 2 (ER 1 to ≤10%) ER+/HER2- prima...
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Elizabeth A Mittendorf, Zoe June Assaf, Nadia Harbeck, et al. Nat Med. 2025 Jul;31(7):2397-2404
Patients with previously untreated stage II/III TNBC enrolled in 75 academic and community sites in 13 countries were randomized 1:1 to receive neoadjuvant chemotherapy with either peri-operative atezolizumab (n = 165) or preopera...
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M Graeser, O Gluz, C Zu Eulenburg, et al. Ann Oncol. 2025 Nov;36(11):1366-1378
A total of 713 patients were analyzed; neoadjuvant chemotherapy (paclitaxel plus pertuzumab plus trastuzumab): n = 149, neoadjuvant chemotherapy-free (pertuzumab plus trastuzumab, trastuzumab-only)/antibody-drug conjugate (ADC, tr...
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The German Guideline Commission (AGO: Working Group on Gynecologic Cancers) updated its recommendations on the diagnosis and treatment of breast cancer in March 2025. The most important changes include the incorporation of INSEMA...
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N Harbeck, S Modi, L Pusztai, et al. Ann Oncol. 2026 Feb;37(2):166-179
DESTINY-Breast11 assessed efficacy and safety of neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) versus dose-dense doxorubicin + cyclophosphamide (ddAC) followed by THP f...
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Sibylle Loibl, Yeon Hee Park, Zhiming Shao, et al. N Engl J Med. 2026 Feb 26;394(9):845-857
A total of 1635 patients were randomly assigned (in a 1:1 ratio) to receive T-DXd (818 patients) or T-DM1 (817 patients). Invasive-disease events or deaths were reported in 51 patients (6.2%) in the T-DXd group and 102 patients (1...
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Sherko Kuemmel, Peter A Fasching, Peter Schmid, et al. Ann Surg Oncol. 2026 Feb 25
We prospectively evaluated surgical outcomes following neoadjuvant pembrolizumab or placebo added to neoadjuvant chemotherapy among participants with early-stage triple-negative breast cancer (TNBC) in the phase 3 KEYNOTE-522 stud...
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Andrew N J Tutt, Judy E Garber, Bella Kaufman, et al. N Engl J Med. 2021 Jun 24;384(25):2394-2405
New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer. We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth...
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F Marmé, M Martin, M Untch, et al. ESMO Open. 2024 Jun;9(6):103466
The PENELOPE-B study demonstrated that the addition of 1-year post-neoadjuvant palbociclib to endocrine therapy (ET) in patients with high-risk early breast cancer (BC) did not improve invasive disease-free survival (iDFS) compare...
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Charles E Geyer Jr, Michael Untch, Chiun-Sheng Huang, et al. N Engl J Med. 2025 Jan 16;392(3):249-257
Patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer with residual invasive disease after neoadjuvant systemic therapy have a high risk of recurrence and death. The primary analysis of KATHERI...
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Charles E Geyer Jr and Sibylle Loibl. Breast. 2025 Jun:81:104450
Reductions in HER2-protein IHC intensity and HER2-gene amplification in residual invasive breast cancer following neoadjuvant therapy for HER2-positive breast cancer have been described and are associated with worse outcomes. T-DM...
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Chiara Dauccia, Maria Alice Franzoi, Samuel Martel, et al Eur J Cancer. 2025 Jun 18:223:115489
We assessed the association of BMI and weight changes with outcomes of patients with HER2-positive early BC included in the APHINITY trial. This is an exploratory analysis of APHINITY (NCT01358877), randomized trial testing adjuva...
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