DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Timeline
- Start
- 2018-08-09
- Primary completion
- 2021-05-21
- Completion
- 2026-08-31
Outcome
Met primary endpoint
release “At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival (PFS).” astrazeneca.com ↗
release “At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1” astrazeneca.com ↗
release “Based on ground-breaking DESTINY-Breast03 results showing AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)” astrazeneca.com ↗
release “DESTINY-Breast03 Phase III trial that showed Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine” astrazeneca.com ↗
release “With the additional follow-up in DESTINY-Breast03, Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS)” astrazeneca.com ↗
release “reaffirming the statistically significant finding at the previous interim analysis.” astrazeneca.com ↗
release “DESTINY-Breast03 Phase III trial, where Enhertu demonstrated a 72% reduction in the risk of disease progression or death” astrazeneca.com ↗
Publications
- Iwata H, Xu B, Kim SB, Chung WP, Park YH, Kim MH, Tseng LM, Chung CF, Huang CS, Kim JH, Chiu JWY, Yamashita T, Li W, Egorov A, Nishijima S, Nakatani S, Nishiyama Y, Sugihara M, Cortes J, Im SA. Trastuzumab deruxtecan versus trastuzumab emtansine in Asian patients with HER2-positive metastatic breast cancer. Cancer Sci. 2024 Sep;115(9):3079-3088. doi: 10.1111/cas.16234. Epub 2024 Jul 9.
- Cortes J, Hurvitz SA, Im SA, Iwata H, Curigliano G, Kim SB, Chiu JWY, Pedrini JL, Li W, Yonemori K, Bianchini G, Loi S, Borges GS, Wang X, Bachelot T, Nakatani S, Ashfaque S, Liang Z, Egorov A, Hamilton E. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med. 2024 Aug;30(8):2208-2215. doi: 10.1038/s41591-024-03021-7. Epub 2024 Jun 2.
- Ma R, Shi Y, Yan R, Yin S, Bu H, Huang J. Efficacy and safety of trastuzumab deruxtecan in treating human epidermal growth factor receptor 2-low/positive advanced breast cancer:A meta-analysis of randomized controlled trials. Crit Rev Oncol Hematol. 2024 Apr;196:104305. doi: 10.1016/j.critrevonc.2024.104305. Epub 2024 Mar 3.
- Cortes J. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer: a plain language summary of the DESTINY-Breast03 study. Future Oncol. 2024 Feb;20(4):167-178. doi: 10.2217/fon-2023-0422. Epub 2023 Dec 7.
- Rugo HS, Crossno CL, Gesthalter YB, Kelley K, Moore HB, Rimawi MF, Westbrook KE, Buys SS. Real-World Perspectives and Practices for Pneumonitis/Interstitial Lung Disease Associated With Trastuzumab Deruxtecan Use in Human Epidermal Growth Factor Receptor 2-Expressing Metastatic Breast Cancer. JCO Oncol Pract. 2023 Aug;19(8):539-546. doi: 10.1200/OP.22.00480. Epub 2023 May 19.
- Curigliano G, Dunton K, Rosenlund M, Janek M, Cathcart J, Liu Y, Fasching PA, Iwata H. Patient-reported outcomes and hospitalization data in patients with HER2-positive metastatic breast cancer receiving trastuzumab deruxtecan or trastuzumab emtansine in the phase III DESTINY-Breast03 study. Ann Oncol. 2023 Jul;34(7):569-577. doi: 10.1016/j.annonc.2023.04.516. Epub 2023 May 12.
- Hurvitz SA, Hegg R, Chung WP, Im SA, Jacot W, Ganju V, Chiu JWY, Xu B, Hamilton E, Madhusudan S, Iwata H, Altintas S, Henning JW, Curigliano G, Perez-Garcia JM, Kim SB, Petry V, Huang CS, Li W, Frenel JS, Antolin S, Yeo W, Bianchini G, Loi S, Tsurutani J, Egorov A, Liu Y, Cathcart J, Ashfaque S, Cortes J. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet. 2023 Jan 14;401(10371):105-117. doi: 10.1016/S0140-6736(22)02420-5. Epub 2022 Dec 7.
- Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.
- Cortes J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Comparator | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |