Table 2.
Ongoing clinical trials in combination with anti-HER2 therapy or immunotherapy. ClinicalTrials.gov April 2019.
| Clinical trials.gov identifier | Phase | Recruitment status | Therapy | Breast tumor type | Estimated enrollment | Primary endpoint |
|---|---|---|---|---|---|---|
| Palbociclib | ||||||
| NCT01976169 | ⅠB | Recruiting | PD-0332991 + T-DM1 | HER2+ ABC | 17 | - MTD - DLT |
| NCT03054363 | ⅠB/Ⅱ | Active, not recruiting | Tucatinib + palbociclib + letrozole | HR+/HER2+ locally advanced unresectable or metastatic breast cancer | 25 | - Phase Ⅰ: AE - Phase Ⅱ: PFS |
| NCT03709082 | Ⅰ/Ⅱ | Recruiting | Palbociclib + letrozole + T-DM1 | Trastuzumab refractory ER+/HER2+ MBC | 62 | ORR |
| NCT03304080 | Ⅰ/Ⅱ | Recruiting | Anastrozole + palbociclib + trastuzumab + pertuzumab | HR+/ HER2+ MBC | 36 | - DLT - MTD - CBR |
| NCT02907918 PALTAN | Ⅱ | Recruiting | Palbociclib + letrozole + trastuzumab | Stage Ⅱ-Ⅲ ER+/HER2+ BC | 48 | pCR rate |
|
NCT02448420 PATRICIA |
Ⅱ | Recruiting | 1. Palbociclib + trastuzumab 2. Palbociclib + trastuzumab.+ letrozole |
Postmenopausal previously-treated locally HER2+ ABC or MBC | 138 | PFS |
|
NCT02530424 NA-PHER2 |
Ⅱ | Active, not recruiting | 1.Trastuzumab + pertuzumab + palbociclib +fulvestrant 2.Trastuzumab + pertuzumab + palbociclib |
Invasive unilateral non metastatic ER+/ HER2+ BC | 102 | - Serial measures of Ki67, - Serial measures of apoptosis |
| NCT02774681 | Ⅱ | Active, not recruiting | Palbociclib + trastuzumab | HER2+ MBC with brain metastasis | 12 | Radiographic response rate in the CNS |
|
NCT03147287 PACE |
Ⅱ | Recruiting | 1. Fulvestrant 2. Fulvestrant + palbociclib 3. Fulvestrant + palbociclib + avelumab |
HR+/HER2- MBC that has previously stopped responding to prior palbociclib and endocrine therapy. | 220 | PFS |
|
NCT02947685 PATINA |
Ⅲ | Recruiting | 1. Palbociclib + trastuzumab/pertuzumab + letrozole, anastrozole, exemstane or fulvestratnt 2.Trastuzumab/pertuzumab + letrozole, anastrozole, exemstane or fulvestrant |
HR+/HER2+ MBC | 496 | PFS |
| Ribociclib | ||||||
| NCT02657343 | ⅠB/Ⅱ | Recruiting | 1. Ribociclib + Trastuzumab 2. Ribociclib + T-DM1 3. Ribociclib + Trastuzumab + fulvestrant |
HER2+ ABC or MBC | 86 | - MTD - CBR |
| Abemaciclib | ||||||
| NCT02057133 | ⅠB | Recruiting | Abemaciclib + trastuzumab + pertuzumab +loperamide dose escalation | MBC | 198 | Number of participants with AE |
|
NCT02675231 monarcHER |
Ⅱ | Active, not recruiting | 1. Abemaciclib + trastuzumab + fulvestrant 2. Abemaciclib + trastuzumab 3.Trastuzumab + chemotherapy |
HR+/ HER2+ locally ABC or MBC | 225 | PFS |
Abbreviations: ER+: estrogen receptor-positive; HR+: hormone receptor-positive; HER2+: human epidermal growth factor receptor 2-positive; MBC: metastatic breast cancer; ABC: advanced breast cancer; BC: breast cancer; AE: adverse events; PFS: progression-free survival; ORR: overall response rate; MTD: maximum tolerated dose; DLT: dose-limiting toxicity; CBR: clinical benefit rate; pCR: pathologic complete response; CNS: central nervous system.