Clinical trial · no report yet · Phase 2
NCT03248492
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
- NCT03248492 ↗
- Terminated
- Daiichi Sankyo
- 63 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| Podcasts | 30 | |
| YouTube | 28 | |
| X threads | 5 |
The trial
ClinicalTrials.gov- Official title
- A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)
- Phase
- Phase 2
- Status
- Terminated
- Conditions
- Breast Cancer
- Interventions
- DS-8201a
- Arms
- DS-8201a Low Dose · Experimental
- DS-8201a Medium Dose · Experimental
- DS-8201a High Dose · Experimental
- Exploratory Arm · Other
- Enrollment
- 253
- Primary outcomes
- Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
- Sponsor
- Daiichi Sankyo with AstraZeneca, Daiichi Sankyo Co., Ltd.
- Start
- Aug 25, 2017
- Primary completion
- Mar 21, 2019
- Results posted
- Yes
- Registry record
- NCT03248492 · updated Jun 26, 2025
Publications
linked from the registry- Dunton K, Vondeling G, Hancock E, Petrou M, Burn O, Paine A. Methods for Estimating Long-Term Outcomes for Trastuzumab Deruxtecan in HER2-Positive Unresectable or Metastatic Breast Cancer After Two or More Anti-HER2 Therapies. Target Oncol. 2022 Nov;17(6):655-663. doi: 10.1007/s11523-022-00923-9. Epub 2022 Nov 7. PubMed 36342619
- 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. PubMed 35964548
- Bardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107. PubMed 35642907
- Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15. PubMed 34263665
- Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10. PubMed 33999422
- Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11. PubMed 31825192