Table 3.
Ongoing clinical trials of lapatinib combination therapy for early or advanced/metastatic breast cancer
| Studya | Patient population | Study design and treatment regimen | Phase | N |
|---|---|---|---|---|
| Lapatinib plus chemotherapy agents | ||||
| NCT00753207 | Relapsed stage III/IV BCb | Open label, dose escalation to MTD, lapatinib + epirubicin | I | 24 |
| NCT00513058 | ErbB2+ relapsed stage III/IV BC | Open label, dose escalation to MTD, lapatinib + vinorelbine | I | 60 |
| NCT00614978 (LAPTEM) | ErbB2+ relapsed brain metastases in BC | Open label, dose escalation to MTD, lapatinib + temozolamide | I | 18 |
| NCT00477464 (109749) | Japanese ErbB2+ trastuzumab-failed MBC | Open label, single-arm, lapatinib + capecitabine | II | 50 |
| NCT00313599 | ErbB2+ relapsed stage III/IV solid tumor | Open label, dose escalation to MTD, lapatinib + Nab-paclitaxel | I | 22 |
| NCT00709761 | ErbB2+ second-line MBC | Open label, single-arm, lapatinib + Nab-paclitaxel | II | 60 |
| NCT00331630 | ErbB2+ BC, neoadjuvant | Open label, pilot study, lapatinib + Nab-paclitaxel | II | 30 |
| NCT00756470 | ErbB2+ inflammatory BC, neoadjuvant | Open label, single-arm, lapatinib + paclitaxel then lapatinib + fluorouracil + epirubicin + cyclophosphamide | II | 60 |
| NCT00404066 | ErbB2+ BC, neoadjuvant | Open label, single-arm, doxorubicin + cyclophosphamide then lapatinib + docetaxel | II | 72 |
| Lapatinib plus chemotherapy and non-chemotherapy agents | ||||
| NCT00632489 | Relapsed stage III/IV solid tumorb | Open label, dose escalation to MTD in three arms, lapatinib + LBH589 versus LBH589 + capecitabine versus lapatinib + LBH589 + capecitabine | I | 55 |
| NCT00820872 | ErbB2+ BC, adjuvant | Open label, single-arm, lapatinib + docetaxel + carboplatin + trastuzumab | II | 33 |
| NCT00841828 | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib + epirubicin + cyclophosphamide + docetaxel versus trastuzumab + epirubicin + cyclophosphamide + docetaxel | II | 102 |
| NCT00769470 | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib + carboplatin + docetaxel versus trastuzumab + carboplatin + docetaxel versus lapatinib + trastuzumab + carboplatin + docetaxel | II | 140 |
| NCT00684983 (45) | ErbB2+ first-line or relapsed MBC | Open label, RCT, lapatinib + capecitabine + IMC-A12 versus lapatinib + capecitabine | II | 154 |
| NCT00770809 (CALGB 40 601) | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib + paclitaxel versus trastuzumab + paclitaxel versus lapatinib + trastuzumab + paclitaxel | III | 400 |
| NCT00667251 (EGF108919, COMPLETE) | ErbB2+ stage IV MBC | Open label, RCT, lapatinib + paclitaxel or docetaxel versus trastuzumab + paclitaxel or docetaxel | III | 600 |
| NCT00820222 (EGF111438, CEREBREL) | ErbB2+ stage IV MBC | Open label, RCT, lapatinib + capecitabine versus trastuzumab + capecitabine | III | 650 |
| NCT00567554 (GepaQuinto) | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib + epirubicin + cyclophosphamide + docetaxel versus trastuzumab + epirubicin + cyclophosphamide + docetaxel versus bevacizumab + epirubicin + cyclophosphamide + docetaxel versus epirubicin + cyclophosphamide + docetaxel versus paclitaxel | III | 2547 |
| Lapatinib plus non-chemotherapy agents | ||||
| NCT00352443 | Relapsed stage III/IV solid tumorb | Open label, dose escalation to MTD, lapatinib + everolimus | I | 48 |
| NCT00499681 | ErbB2+ BC, neoadjuvant | Double-blind, RCT, lapatinib + letrozole versus placebo + letrozole | II | 36 |
| NCT00118157 | Tamoxifen-resistant MBCb | Open label, single-arm, lapatinib + tamoxifen | II | 41 |
| NCT00548184 | ErbB2+ BC, neoadjuvant | Double-blind RCT, lapatinib + trastuzumab + endocrine therapy versus lapatinib + trastuzumab | II | 64 |
| NCT00390455 (CALGB 40 302) | First-line or relapsed advanced BCb | Open label, RCT, lapatinib + fulvestrant versus placebo + fulvestrant | III | 324 |
| NCT00688194 | Aromatase inhibitor-relapsed MBCb | Double-blind, RCT, lapatinib + fulvestrant versus placebo + fulvestrant versus lapatinib + aromatase inhibitor + fulvestrant versus aromatase inhibitor + fulvestrant | III | 396 |
| NCT00553358 (EGF106903, BIG 1-06, NeoALTTO) | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib versus trastuzumab versus lapatinib + trastuzumab; addition of paclitaxel for all treatment arms after 6 weeks | III | 450 |
| NCT00486668 (NSABP B-41) | ErbB2+ BC, neoadjuvant | Open label, RCT, lapatinib + AC + paclitaxel versus trastuzumab + AC + paclitaxel versus lapatinib + trastuzumab + AC + paclitaxel | III | 522 |
| NCT00490139 (EGF106708, BIG 2-06, ALTTO) | ErbB2+ BC, adjuvant | Open label, RCT, lapatinib versus trastuzumab versus trastuzumab then lapatinib versus lapatinib + trastuzumab | III | 8000 |
AC, doxorubicin + cyclophosphamide; BC, breast cancer; ErbB2+, human epidermal growth factor receptor 2-positive; MBC, metastatic breast cancer; MTD, maximum tolerated dose; RCT, randomized controlled trial.
aStudy identification codes for trials registered in the National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov, accessed 5 November 2009).
bPatient population ErbB2 status unknown.