Table 3.
Summary of clinical trials currently underway
| ClinicalTrials.gov identifier | Phase | Name | Status | Sponsor | Number of patients | Study design |
|---|---|---|---|---|---|---|
| NCT01816035 | I | N/A | Not open yet | University of Washington | 20 (estimated) | HER2-positive MBC or locally advanced breast cancer that cannot be removed by surgery. |
| NCT02038010 | I | N/A | Currently recruiting | Northwestern University | 28 (estimated) | To assess combination of T-DM1 and BYL719 for safety and efficacy in treating MBC. |
| NCT01513083 | I | N/A | Currently recruiting | Hoffmann-La Roche | 30 (estimated) | HER2-positive MBC with normal or reduced hepatic function. |
| NCT00934856 | I | N/A | Completed | Hoffmann-La Roche | 99 | Adding T-DM1 to docetaxel in patients with locally advanced or HER2-positive MBC. For patients with locally advanced breast cancer, pertuzumab may be added to T-DM1 and docetaxel. |
| NCT00928330 | I | N/A | Completed | Genentech | 57 | Oral GDC 0941 administered in combination with either IV infusion of T-DM1 or IV infusion of trastuzumab. |
| NCT01513083 | I | N/A | Currently recruiting | Hoffmann-La Roche | 30 (estimated) | Evaluate the pharmacokinetics and safety of T-DM1 in patients with HER2-positive MBC and normal or reduced hepatic function. |
| NCT02073916 | I | STELA | Currently recruiting | The Methodist Hospital System | 18 (estimated) | Assess the safety and tolerability of combining T-DM1 with lapatinib and abraxane in patients with HER2-positive MBC. |
| NCT01983501 | Ib | N/A | Currently recruiting | Oncothyreon Inc. | 48 (estimated) | Determine the maximum tolerated dose or recommended dose and assess the safety and tolerability of ONT-380 combined with T-DM1 in patients with HER2-positive breast cancer. |
| NCT01976169 | Ib | N/A | Not yet open | University of Texas Southwestern Medical Center | 17 (estimated) | Phase 1b inter-patient dose-escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. |
| NCT00951665 | Ib-IIa | N/A | Completed | Genentech | 107 | T-DM1, paclitaxel, and pertuzumab in patients with HER2-positive locally advanced breast cancer or MBC. |
| NCT01702558 | I and II | N/A | Currently recruiting | Hoffmann-La Roche | 240 (estimated) | Maximum tolerated dose of capecitabine in combination with T-DM1 in patients with HER2-positive MBC or locally advanced or metastatic gastric cancer using a Phase I design, followed by a Phase II single-arm study to explore the efficacy of the combination in MBC patients. |
| NCT02070094 | I and II | N/A | Currently recruiting | Ukrainian Antitumor Center | 80 (estimated) | A Phase I/II study of T-DM1 plus ABT-737 in treating patients with HER2-positive breast cancer. |
| NCT01196052 | II | N/A | Ongoing, not recruiting anymore | Hoffmann-La Roche | 153 | T-DM1 after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. |
| NCT01975142 | II | N/A | Currently recruiting | Institut Curie | 480 (estimated) | Patients with MBC considered HER2-negative are screened for HER2-amplified circulating tumor cells. If HER2-amplifed circulating tumor cells are detected, patients are treated with T-DM1. |
| NCT01853748 | II | ATEMPT | Currently recruiting | Dana-Farber Cancer Institute | 500 (estimated) | T-DM1 (×17) versus paclitaxel (weekly ×12)/trastuzumab (every 3 weeks ×13) for stage I (small) HER2-positive breast cancer.50 |
| NCT01745965 | II | N/A | Currently recruiting | West German Study Group | 380 (estimated) | Preoperative T-DM1 with or without standard endocrine therapy versus trastuzumab with standard endocrine therapy given for 12 weeks in patients with operable HER2-positive/HR+ breast cancer within the ADAPT protocol. |
| NCT00781612 | II | N/A | Enrolling participants by invitation only | Genentech | 720 (estimated) | Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel. |
| NCT01835236 | II | N/A | Currently recruiting | Swiss Group for Clinical Cancer Research | 208 (estimated) | Trastuzumab and pertuzumab followed by T-DM1 in MBC. |
| NCT01597414 | II | N/A | Currently recruiting | EORTC | 80 (estimated) | Elderly MBC: pertuzumab–Herceptin versus pertuzumab–Herceptin–metronomic chemotherapy, followed by T-DM1. |
| NCT02073487 | II | N/A | Currently recruiting | The Methodist Hospital System | 30 (estimated) | Evaluate the pathological CR when T-DM1 and lapatinib and abraxane are combined in newly diagnosed HER2-positive breast cancer. |
| NCT01565200 | II | ZEPHIR | Ongoing, not recruiting anymore | Jules Bordet Institute | 60 (estimated) | HER2 imaging study to identify HER2-positive MBC patients unlikely to benefit from T-DM1. |
| NCT01904903 | II | SAFE-HEaRt | Currently recruiting | Washington Hospital Center | 33 (estimated) | Cardiac safety study in patients with HER2-positive breast cancer. |
| NCT01702571 | III | N/A | Currently recruiting | Hoffmann-La Roche | 2,220 (estimated) | T-DM1 in patients with HER2-positive locally advanced breast cancer or MBC who have received prior anti-HER2 and chemotherapy-based treatment. Patients will receive 3.6 mg/kg T-DM1 intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.51 |
| NCT01772472 | III | KATHERINE | Currently recruiting | Hoffmann-La Roche | 1,484 (estimated) | T-DM1 versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Radiotherapy and/or hormone therapy will be given in addition if indicated.49 |
| NCT01120184 | III | MARIANNE | Ongoing, not recruiting anymore | Hoffmann-La Roche | 1,095 | T-DM1 with pertuzumab or T-DM1 with pertuzumab–placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive or recurrent locally advanced or previously untreated MBC.48 |
| NCT01419197 | III | TH3RESA | Ongoing, not recruiting anymore | Hoffmann-La Roche | 604 | T-DM1 in comparison with treatment of the physician’s choice in patients with metastatic or unresectable locally advanced/recurrent HER2-positive breast cancer.9 |
| NCT01966471 | III | KAITLIN | Currently recruiting | Hoffmann-La Roche | 2,500 (estimated) | Evaluate the efficacy and safety of T-DM1 plus pertuzumab versus trastuzumab plus pertuzumab and taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer following surgery and anthracycline-based chemotherapy.52 |
| NCT00833963 | IV | MotHER | Currently recruiting | Genentech | 100 (estimated) | The MotHER Pregnancy Registry is a cohort study in women with breast cancer who have been or are being treated with a trastuzumab-containing regimen with or without pertuzumab, or ado-trastuzumab emtansine, during pregnancy or within 6 months prior to conception. |
Abbreviations: HER2, human epidermal growth factor receptor 2; IV, intravenous; MBC, metastatic breast cancer; N/A, not applicable; T-DM1, trastuzumab emtansine; EORTC, European Organisation for Research and Treatment of Cancer; CR, complete remission.