Table 2.
Ongoing/completed phase III or ongoing phase IV clinical trials evaluating trastuzumab emtansine or trastuzumab deruxtecan in patients with HER2-positive breast cancer as of February 2023
| ADC | Treatment arms | Sponsor | Indications | Phase (status) | NCT identifier |
|---|---|---|---|---|---|
| Trastuzumab emtansine (ado-trastuzumab emtansine; T-DM1) | T-DXd versus T-DM1 | Daiichi Sankyo | high-risk patients with residual invasive breast cancer following neoadjuvant therapy | III (recruiting) | NCT04622319 |
| T-DXd versus T-DM1 | Daiichi Sankyo | patients with HER2-positive, unresectable, and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane | III (active, not recruiting) | NCT03529110 | |
| Tucatinib in combination with T-DM1 versus placebo in combination with T-DM1 | Seagen | patients with unresectable locally advanced or metastatic HER2-positive breast cancer | III (recruiting) | NCT03975647 | |
| T-DM1 | Hoffmann-La Roche | patients with HER2-positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment | III (completed) | NCT01702571 | |
| T-DM1 versus T-DM1 and tucatinib | Alliance for Clinical Trials in Oncology | patients with high-risk HER2-positive breast cancer | III (recruiting) | NCT04457596 | |
| T-DM1 versus TPC | Hoffmann-La Roche | patients with HER2-positive metastatic breast cancer who have received at least two prior regimens of HER2-directed therapy | III (completed) | NCT01419197 | |
| T-DM1 versus taxane (docetaxel or paclitaxel) | Hoffmann-La Roche | patients with previously treated locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction | II/III (terminated) | NCT01641939 | |
| T-DM1 in combination with atezolizumab or placebo | Hoffmann-La Roche | patients with HER2-positive and PD-L1-positive locally advanced or metastatic breast cancer who have received prior trastuzumab (±pertuzumab)-based and taxane-based therapy | III (recruiting) | NCT04740918 | |
| T-DM1 versus lapatinib plus capecitabine | Hoffmann-La Roche | patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy | III (active, not recruiting) | NCT03084939 | |
| T-DM1 in combination with pertuzumab or T-DM1 in combination with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first-line treatment | Hoffmann-La Roche | patients with HER2-positive progressive or recurrent locally advanced or metastatic breast cancer | III (completed) | NCT01120184 | |
| T-DM1 plus pertuzumab versus chemotherapy plus trastuzumab and pertuzumab | Hoffmann-La Roche | patients with HER2-positive breast cancer | III (completed) | NCT02131064 | |
| T-DM1 versus capecitabine in combination with lapatinib | Hoffmann-La Roche | patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy | III (completed) | NCT00829166 | |
| T-DM1 versus the combination of trastuzumab plus docetaxel as first-line treatment | Hoffmann-La Roche | patients with HER2-positive progressive or recurrent locally advanced or metastatic breast cancer | III (terminated) | NCT02144012 | |
| adjuvant atezolizumab or placebo and T-DM1 | Hoffmann-La Roche | patients with HER2-positive breast cancer at high risk of recurrence following preoperative therapy | III (recruiting) | NCT04873362 | |
| T-DM1 versus trastuzumab as adjuvant therapy | Hoffmann-La Roche | patients with HER2-positive primary breast cancer who have residual tumor present pathologically in the breast or axillary lymph nodes following preoperative therapy | III (active, not recruiting) | NCT01772472 | |
| T-DM1 plus pertuzumab following anthracyclines versus trastuzumab plus pertuzumab plus a taxane following anthracyclines | Hoffmann-La Roche | patients with operable HER2-positive primary breast cancer | III (completed) | NCT01966471 | |
| T-DM1 versus capecitabine | University of Virginia | patients with high-risk breast cancer | II/III (not yet recruiting) | NCT05288777 | |
| combination of docetaxel, trastuzumab, and pertuzumab (arm A) or T-DM1 (arm B) | Thomas Hatschek | patients with HER2-positive breast cancer | II/III (active, not recruiting) | NCT02568839 | |
| Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki; T-DXd; DS8201a) | T-DXd versus T-DM1 | Daiichi Sankyo | high-risk patients with residual invasive breast cancer following neoadjuvant therapy | III (recruiting) | NCT04622319 |
| T-DXd with or without pertuzumab versus taxane, trastuzumab, and pertuzumab | AstraZeneca | patients with HER2-positive, first-line metastatic breast cancer | III (recruiting) | NCT04784715 | |
| T-DXd versus investigator’s choice chemotherapy | AstraZeneca | patients with HER2-low, hormone receptor-positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting | III (recruiting) | NCT04494425 | |
| T-DXd monotherapy or T-DXd in sequence with THP versus standard treatment (ddAC-THP) | AstraZeneca | patients with high-risk HER2-positive early-stage breast cancer | III (recruiting) | NCT05113251 | |
| T-DXd | AstraZeneca | patients with or without baseline brain metastasis with previously treated advanced/metastatic HER2-positive breast cancer | IIIb/IV (recruiting) | NCT04739761 | |
| T-DXd | AstraZeneca | patients with unresectable, locally advanced, or metastatic NSCLC harboring HER2 exon 19 or 20 mutations | III (recruiting) | NCT05048797 | |
| T-DXd versus T-DM1 | Daiichi Sankyo | patients with HER2-positive, unresectable, and/or metastatic breast cancer previously treated with trastuzumab and taxane | III (active, not recruiting) | NCT03529110 | |
| T-DXd versus ramucirumab and paclitaxel | Daiichi Sankyo | patients with HER2-positive gastric or GEJ adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy | III (recruiting) | NCT04704934 |
HER2, human epidermal growth factor receptor 2; ADC, antibody-drug conjugate; HR, hormonal receptor; AC, Adriamycin + cyclophosphamide; THP, Taxol + Herceptin + pertuzumab; NSCLC, non-small cell lung cancer; TPC, treatment of physician’s choice; GEJ, gastroesophageal junction.