Table 2.
Ongoing clinical trials with T-DM1
| Trial name | Phase | Patient population | Number to be enrolled | Treatment groups |
|---|---|---|---|---|
| MARIANNE (NCT01120184) | 3 | First-line HER2+ MBC | 1,092 | T-DM1 + placebo versus T-DM1 + pertuzumab versus trastuzumab + a taxane |
| TDM4652g (NCT00951665) | 1b | Previously treated HER2+ MBC | 107 | T-DM1 + paclitaxel ± pertuzumab |
| BP22572 (NCT00934856) | 1b/2a | Previously treated HER2+ MBC | 99 | T-DM1 + docetaxel ± pertuzumab |
| KAITLIN (NCT01966471) | 3 | Adjuvant | 2,500 | AC/FEC→ T-DM1/pertuzumab versus AC/FEC → trastuzumab/pertuzumab/taxane |
| ATEMPT (NCT01853748) | 2 | Stage 1 adjuvant | 500 | T-DM1 ×1 year versus paclitaxel/trastuzumab × 12 weeks, followed by trastuzumab maintenance to complete 1 year |
| KRISTINE (NCT02131064) | 2 | Neoadjuvant | 432 | T-DM1/pertuzumab versus taxotere/carboplatin/trastuzumab/pertuzumab |
| ADAPT (NCT01745965) | 2 | Neoadjuvant | 380 | T-DM1 ± endocrine therapy versus trastuzumab + endocrine therapy for 12 weeks before surgery |
| KATHERINE (NCT01772472) | 3 | Residual disease after neoadjuvant therapy | 1,484 | T-DM1 versus trastuzumab maintenance for 14 cycles after surgery |
| Trastuzumab and Pertuzumab followed by T-DM1 in MBC (NCT01835236) | 2 | First-line HER2+ MBC | 208 | Trastuzumab and pertuzumab (no chemotherapy) in first-line MBC followed by T-DM1 in second-line MBC in the event of progression versus trastuzumab/pertuzumab/paclitaxel or vinorelbine in first-line MBC followed by T-DM1 in second-line MBC in event of progression |
| BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab and Taxane Tx (NCT02038010) | 1 | Previously treated HER2+ MBC with progression on prior trastuzumab and taxane-based therapy | 28 | BYL719 (PI3K inhibitor) orally daily on days 1–21 and T-DM1 every 3 weeks |
| GDC-0941 administered orally to patients with Trastuzumab- DM1 or trastuzumab (NCT00928330) | 1 | Previously treated HER2+ MBC who progressed on trastuzumab-based therapy | 57 | Oral GDC-0941 (PI3K inhibitor) daily and T-DM1 or trastuzumab |
| STELA (NCT02073916) | 1 | Previously treated MBC with at least two prior therapies | 18 | T-DM1 intravenously every 3 weeks in combination with lapatinib daily plus abraxane intravenously weekly |
| ONT380 + TDM1 (NCT01983501) | 1 | Previously treated HER2+ MBC with taxane and trastuzumab | 48 | ONT380 orally twice a day with T-DM1 intravenously |
| Phase 1b Study of PD-0332991 in Combination With T-DM1 (NCT01976169) | 1 | Previously treated MBC with HER2+ and RB proficient tumor | 17 | T-DM1 intravenously on day 1 with PD-0332991 (palbociclib) on days 5–18 of every 21-day cycle |
Abbreviations: MARIANNE, A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer; HER, human growth factor receptor; MBC, metastatic breast cancer; TDM4652g, A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer; T-DM1, trastuzumab emtansine; BP22572, A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer; KAITLIN, A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer; AC/FEC, adriamycin, cyclophosphamide/5-fluorouracil, epirubicin, and cyclophosphamide; ATEMPT, T-DM1 vs Paclitaxel/Trastuzumab for Breast; KRISTINE, A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer; ADAPT, A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol; KATHERINE, A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy; GDC-0941 administered orally to patients with Trastuzumab-DM1 or trastuzumab, Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy; STELA, TDM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer; ONT380 + TDM1, A Phase 1b Study of ONT-380 Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer.