Entry Detail
| General information | |
| Database: | DB01049 |
| Objective: | Neoadjuvant Lapatinib and Trastuzumab With Hormonal Therapy and Without Chemotherapy in Patients With Human Epidermal Growth Factor Receptor 2-Overexpressing Breast Cancer |
| Authors: | Mothaffar F. Rimawi |
| Title: | Multicenterphase II study of neoadjuvant lapatinib and trastuzumab with hormonal therapy and without chemotherapy in patients with human epidermal growth factor receptor 2overexpressing breast cancer: TBCRC 006. |
| Journal: | journal of clinical oncology |
| Year: | 2013 |
| PMID: | 23569315 |
| Trial Design | |
| Clinical Trial Id: | NCT00548184 |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 18 |
| Therapeutic Combination Content: | neoadjuvant lapatinib and trastuzumab with hormonal therapy and without chemotherapy |
| Study Type: | Multicenterphase II |
| Key Patients Feature: | women age more than and equal to 18 years with histologically confirmed invasive human epidermal growth factor receptor 2positive breast cancer. human epidermal growth factor receptor 2 positivity was defined as overexpression by immunohistochemistry (3+) or amplification by fluorescent in situ hybridization. Breast tumorswere required to be >3cmbyclinical measurement or > 2 cm with a palpable ipsilateral axillary lymph node confirmed by two physicians. |
| Biomarker: | ERpositive |
| Biomark Analysis: | Overall, inbreast pathologic complete response (pCR; ypT0is) was 27% (ER positive, 21%; ER negative, 36%). The rate of lowvolume residual disease (ypT1ab) was 22% (ER positive, 33%; ER negative, 4%). |
| Control Group Info: | single arm |
| Treatment Info: | trastuzumab once per week (4 mg/kg loading, then 2 mg/kg) and lapatinib 1000 mg once per day for 12 weeks. Women with ERpositive tumors also received letrozole (plus a luteinizing hormone- releasing hormone [LHRH] agonist if premenopausal). |
| Primary End Point: | Study goals were to measure the rate of pathologic complete response (pCR; disappearance of all invasive tumor in the breast) as well as pathologic response rate, defined as pCR plus residual invasive disease ofless than and equal to 1 cm (ypT1ab) at the time of surgery. |
| Secondary End Point: | NA |
| Patients Number: | 65 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | In the ERpositive group, pCR was 21%, whereas in the ERnegative group, it was 36%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Themostcommontoxicities were diarrhea (grades 1 to 2, 63%; grades 3 to 4, 3%) followed by rash (grades 1 to 2, 55%; grades 3 to 4, 1%), fatigue (32%), nausea (31%), and elevated liver function tests (grades 1 to 2, 18%;grade 3, 5%;grade 4, 2%). Only one grade 4 toxicity was observed in the study (elevated liver function tests), which completely normalized after 8 weeks. |
| Conclusions: | In patients with locally advanced human epidermal growth factor receptor 2positive breast cancer, our approach of targeted therapy only resulted in a high pCR rate without chemotherapy. Our data support the hypothesis that selected patients with human epidermal growth factor receptor 2positive tumors may not need chemotherapy, and morecomplete blockade of HER receptors and ER is an effective strategy worthy of further study |