| Consensus Statement | Quality of Evidence | Strength of Rec. | Key Ref |
|---|---|---|---|
| 1. PARP inhibitors could be used for patients bearing deleterious germline BRCA1/2 mutations who fail or are not suitable for endocrine therapy (ET) and have received at least one line of chemotherapy either in early or metastatic setting. | I | A | 1,2 |
| 2. Trastuzumab deruxtecan could be used for patients with HR+/HER2-low (HER2 IHC 1+ or HER2 IHC 2+ with negative FISH) or HER2-ultralow (HER2 IHC 0 with membrane staining) metastatic breast cancer who fail ≥ 2 lines of ET or 1 line of ET but with indicated conditions.a | I | A | 3,4,5 |
| 3. Datopotamab deruxtecan could be used for patients with HR+/HER2-negative metastatic breast cancer who fail ET and ≥ 1 line of chemotherapy.b | I | A | 6 |
| 4. Sacituzumab govitecan could be used for patients with HR+/HER2- metastatic breast cancer who fail ET and ≥2 lines of chemotherapy.c | I | A | 7,8,9 |
| 5. Abemaciclib as monotherapy could be considered for patients with HR+/HER2- metastatic breast cancer with disease progression following ET and prior chemotherapy in the metastatic setting.d | II | B | 10 |
- If patients only experience 1 line of ET, the condition can be as follows: progression ≤ 6 months of starting first-line ET + CDK4/6i, recurrence ≤ 24 months of starting adjuvant ET, or failure of ≥ 1 line of chemotherapy.
- TROPION-Breast01 trial did not enroll patients who received more than two lines of chemotherapy.
- TROPiCS-02 trial did not enroll patients who received more than four lines of chemotherapy.
- The dosage of Abemaciclib used in MONARCH 1 trial was 200mg twice a day, which caused notable diarrhea.
References
- Robson, M., et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. New England Journal of Medicine, 2017.
- Litton, J. K., et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. New England Journal of Medicine, 2018.
- Modi, S., et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. New England Journal of Medicine, 2022.
- Modi, S., et al. Trastuzumab deruxtecan in HER2-low metastatic breast cancer… DESTINY-Breast04 trial. Nature Medicine, 2025.
- Bardia, A., et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. New England Journal of Medicine, 2024.
- Bardia, A., et al. Datopotamab deruxtecan versus chemotherapy… TROPION-Breast01. Journal of Clinical Oncology, 2025.
- Schmid, P., et al. Sacituzumab govitecan (SG) efficacy… TROPiCS-02 study. Annals of Oncology, 2022.
- Rugo, H. S., et al. Overall survival with sacituzumab govitecan… TROPiCS-02. The Lancet, 2023.
- Xu, B., Wang, S., Yan, M., Sohn, J., Li, W., Tang, J., … & Dai, M. S. (2024). Sacituzumab govitecan in HR+ HER2− metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nature Medicine, 30(12), 3709-3716.
- Dickler, M. N., et al. MONARCH 1, a phase II study of abemaciclib… Clinical Cancer Research, 2017.