Table 2.
Clinical trials involving Margetuximab in breast cancer patients.
| NCT Identifier | Year of Clinical Study | Study Title | Phase and Study Design |
Study Participant | Study Type | Subject Number | Status | Study Arm |
|---|---|---|---|---|---|---|---|---|
| NCT01148849 [73] | 2010 | Safety study of Margetuximab in HER2+ carcinomas | I-Single Group Assignment, open label, treatment purpose | ≥18 years (adults, older adults), with confirmed HER2 + MBC | IV | 66 | Completed | Margetuximab |
| NCT01828021 [60] | 2013 | Phase 2 study of Margetuximab in patients with relapsed or refractory advanced BC | II-Single Group Assignment, open label, treatment purpose | Age ≥ 18 years (adults, older adults), with confirmed invasive BC | IV | 25 | Completed | Margetuximab |
| NCT02492711 [76] | 2015 | Margetuximab plus chemotherapy vs. Trastuzumab plus chemotherapy in the treatment of HER2 + MBC (SOPHIA) |
III-Randomized, parallel assignment, open label, treatment purpose | Age ≥ 18 years (adults, older adults), with confirmed HER2 + MBC | IV | 624 | Completed | Margetuximab and the chosen chemotherapy (Capecitabine/Vinorelbine/Eribulin/Gemcitabine) vs. Trastuzumab and the chosen chemotherapy |
| NCT03133988 | 2017 | Margetuximab Expanded Access Program | not available | Children, adults, older adults | EA | Case -by-case basis | Approved for marketing | Margetuximab |
| NCT04262804 | 2020 | A study to evaluate the efficacy and safety of Margetuximab plus chemotherapy in the treatment of Chinese patients with HER2 + MBC | II-Randomized, parallel assignment, open label, treatment purpose | Male or female, age ≥ 18 years, with confirmed HER2 + MBC; have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting | IV | 120 | Recruiting | Margetuximab and the chosen chemotherapy (Capecitabine/Vinorelbine/Gemcitabine) vs. Trastuzumab and the chosen chemotherapy |
| NCT04398108 | 2020 | A study to evaluate the pharmacokinetics of Margetuximab in Chinese patients with HER2 + MBC | I-Single group assignment, open label, treatment purpose | Male or female, age ≥ 18 years, with confirmed HER2 + MBC; have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting | IV | 16 | Completed | Margetuximab and the chosen chemotherapy (Capecitabine/Vinorelbine/Gemcitabine) |
| NCT04425018 | 2020 | MARGetuximab or trastuzumab (MARGOT) (MARGOT) | II-Randomized, parallel assignment, open label, treatment purpose | Male or female, age ≥ 18 years, with confirmed Stage II or III invasive BC | IV | 171 | Recruiting | Arm (a): Paclitaxel, Pertzumab, and Margetuximab; arm (b): Paclitaxel, Pertzumab, and Trastuzumab |
Note: ClinicalTrials.gov entries as of September 2021 are listed. Abbreviations: IV, Interventional; EA, Expanded Access; BC, breast cancer; MBC, metastatic breast cancer.