Table 2.
Ongoing clinical trials with sacituzumab govitecan for patients with breast cancer
| Trial | Phase | Treatment setting | Breast cancer subtype | Patient population | Design | Experimental arm | Control arm | Sample size | NCT number | Recruitment status (locations) |
|---|---|---|---|---|---|---|---|---|---|---|
| Unresectable locally advanced/metastatic setting | ||||||||||
| TROPiCS-02 | III | Advanced | HR+/HER2− | After ≥2 and ≤4 prior chemotherapy regimens for metastatic disease | Open-label RCT | SG | Capecitabine, eribulin, gemcitabine or vinorelbine | 520 | NCT03901339 | Recruitment closed |
| EVER-132-002 | III | Metastatic | HR+/HER2− | After ≥2 and ≤4 prior chemotherapy regimens for metastatic disease | Open-label RCT | SG | Capecitabine, eribulin, gemcitabine or vinorelbine | 330 | NCT04639986 | Recruiting (Republic of Korea, Taiwan) |
| IMMU-132-14 | III | Metastatic | TNBC HR+/HER2− HER2+ |
Metastatic solid tumors, rollover from parent SG studies | Single-arm rollover study | SG | NA | 200 | NCT04319198 | On invitation |
| Saci-IO TNBC | II | Metastatic | TNBC | mTNBC, PD-L1 negative | Open-label RCT | SG + pembrolizumab | SG | 110 | NCT04468061 | Recruiting (United States) |
| Saci-IO HR+ | II | Metastatic | HR+/HER2− | HR+/HER2− mBC | Open-label RCT | SG + pembrolizumab | SG | 110 | NCT04448886 | Recruiting (United States) |
| EVER-132-001 | IIb | Metastatic | TNBC | After ≥2 prior chemotherapy | Single arm | SG | NA | 80 | NCT04454437 | Recruiting (China) |
| S2007 | II | Brain metastases | TNBC HR+/HER2− |
Patients with brain metastases with CNS progression after previous CNS-directed therapy | Single arm | SG | NA | 44 | NCT04647916 | Recruiting (United States) |
| SEASTAR | Ib/II | Advanced | TNBC Other subtypesa |
After progression on standard treatment | Dose finding and expansion | SG + rucaparib | NA | 329 | NCT03992131 | Recruiting (United States) |
| Morpheus-TNBC | Ib/II | Advanced | TNBC | First-line advanced setting | Open-label, randomized umbrella study | SG + atezolizumab | SG + nab-paclitaxel | 280 | NCT03424005 | Recruiting (Australia, France, Germany, Israel, Republic of Korea, Spain, UK, United States) |
| 19-239 | Ib/II | Metastatic | TNBC | All treatment lines | Dose finding and expansion | SG + talazoparib | NA | 75 | NCT04039230 | Recruiting (United States) |
| Neuro/SG/breast Brain | 0 | Brain metastases | TNBC HR+/HER2− HER2+ |
Breast cancer with known/suspected brain metastases, planned to undergo craniotomy | Single arm | SG | NA | 20 | NCT03995706 | Recruiting (United States) |
| Early/curative setting | ||||||||||
| SASCIA | III | Post-neoadjuvant | TNBC HR+/HER2− |
Residual disease after neoadjuvant chemotherapy | Open-label RCT | SG | Capecitabine, carboplatin or cisplatin | 1200 | NCT04595565 | Recruiting (Germany) |
| NeoSTAR | II | Early or locally advanced | TNBC | Neoadjuvant setting, previously untreated TNBC | Single arm | SG + pembrolizumab | SG | 50 | NCT04230109 | Recruiting (United States) |
Source: ClinicalTrials.gov: March 2021.
CNS, central nervous system; HER2, human epidermal growth factor receptor-2; HR, hormone receptor; mBC, metastatic breast cancer; mTNBC, metastatic triple-negative breast cancer; NA, not applicable; NCT, National Clinical Trial; PD-L1, programmed death-ligand 1; RCT, randomized, controlled trial; SG, sacituzumab govitecan-hziy; TPC, treatment of physician choice.
a
If BRCA1/2, PALB2, RAD51C or RAD51D deleterious mutation.