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- Title
A randomized, controlled phase II trial of neoadjuvant ado-trastuzumab emtansine, lapatinib, and nab-paclitaxel versus trastuzumab, pertuzumab, and paclitaxel in HER2-positive breast cancer (TEAL study).
- Authors
Patel, Tejal A.; Ensor, Joe E.; Creamer, Sarah L.; Boone, Toniva; Rodriguez, Angel A.; Niravath, Poly A.; Darcourt, Jorge G.; Meisel, Jane L.; Li, Xiaoxian; Zhao, Jing; Kuhn, John G.; Rosato, Roberto R.; Qian, Wei; Belcheva, Anna; Schwartz, Mary R.; Kaklamani, Virginia G.; Chang, Jenny C.
- Abstract
<bold>Background: </bold>Neoadjuvant dual human epidermal growth factor receptor (HER2) blockade with trastuzumab and pertuzumab plus paclitaxel leads to an overall pathologic complete response (pCR) rate of 46%. Dual HER2 blockade with ado-trastuzumab emtansine (T-DM1) and lapatinib plus nab-paclitaxel has shown efficacy in patients with metastatic HER2-positive breast cancer. To test neoadjuvant effectiveness of this regimen, an open-label, multicenter, randomized, phase II trial was conducted comparing T-DM1, lapatinib, and nab-paclitaxel with trastuzumab, pertuzumab, and paclitaxel in patients with early-stage HER2-positive breast cancer.<bold>Methods: </bold>Stratification by estrogen receptor (ER) status occurred prior to randomization. Patients in the experimental arm received 6 weeks of targeted therapies (T-DM1 and lapatinib) followed by T-DM1 every 3 weeks, lapatinib daily, and nab-paclitaxel weekly for 12 weeks. In the standard arm, patients received 6 weeks of trastuzumab and pertuzumab followed by trastuzumab weekly, pertuzumab every 3 weeks, and paclitaxel weekly for 12 weeks. The primary objective was to evaluate the proportion of patients with residual cancer burden (RCB) 0 or I. Key secondary objectives included pCR rate, safety, and change in tumor size at 6 weeks. Hypothesis-generating correlative assessments were also performed.<bold>Results: </bold>The 30 evaluable patients were well-balanced in patient and tumor characteristics. The proportion of patients with RCB 0 or I was higher in the experimental arm (100% vs. 62.5% in the standard arm, p = 0.0035). In the ER-positive subset, all patients in the experimental arm achieved RCB 0-I versus 25% in the standard arm (p = 0.0035). Adverse events were similar between the two arms.<bold>Conclusion: </bold>In early-stage HER2-positive breast cancer, the neoadjuvant treatment with T-DM1, lapatinib, and nab-paclitaxel was more effective than the standard treatment, particularly in the ER-positive cohort.<bold>Trial Registration: </bold>Clinicaltrials.gov NCT02073487 , February 27, 2014.
- Subjects
PACLITAXEL; LAPATINIB; EPIDERMAL growth factor receptors; BREAST cancer; METASTATIC breast cancer
- Publication
Breast Cancer Research, 2019, Vol 21, Issue 1, pN.PAG
- ISSN
1465-5411
- Publication type
journal article
- DOI
10.1186/s13058-019-1186-0