Study | study type
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Pathology | T1 | T0 | Patients | sample sizes | ROB | Results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus lapatinib | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lapatinib plus trastuzumab | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EGF104900, 2010 NCT00320385 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | lapatinib plus trastuzumab | lapatinib monotherapy | Patients with HER2-positive mBC who had experienced progression on prior trastuzumab-based therapy. Patients must have received prior anthracycline- and taxane-based regimens in either the adjuvant or metastatic setting. | 148 / 148 | some concern | suggested |
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versus lapatinib plus capecitabine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
neratinib plus capecitabine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
NALA, 2020 NCT01808573 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | neratinib plus capecitabine | lapatinib plus capecitabine | Pateints with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases. | 307 / 314 | some concern | conclusif |
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NALA (brain metastases), 2020 NCT01808573 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | neratinib plus capecitabine | lapatinib plus capecitabine | Patients with centrally confirmed HER2-positive mBC, and ≥ 2 previous HER2-directed therapies for mBC. Patients with brain metastases were eligible unless they had symptomatic or unstable brain metastases.For this comparison, patients with brain metastases | 51 / 50 | some concern | inconclusive |
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versus placebo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
neratinib | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ExteNET, 2016 NCT00878709 | RCT | breast cancer - adjuvant, la/mBC - HER2 positive - 2nd Line (L2) | neratinib | placebo | Women with locally confirmed invasive HER2-positive BC stage 1-3, who had received trastuzumab and chemotherapy. | 1420 / 1420 | low | conclusif |
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versus trastuzumab plus capecitabine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lapatinib plus capecitabine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
WJOG6110B/ELTOP, 2018 UMIN000005219 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | lapatinib plus capecitabine | trastuzumab plus capecitabine | Women, aged 20yr or older, cith HER2-positive mBC or unresectable locally advanced BC who were previously treated with taxanes, with progression on trastuzumab-containing regimens | 43 / 43 | NA | suggested |
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tucatinib plus trastuzumab plus capecitabine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
HER2CLIMB (patients with brain metastases), 2020 NCT02614794 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | tucatinib plus trastuzumab plus capecitabine | placebo plus trastuzumab plus capecitabine | Patients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor. | 198 / 93 | low | conclusif |
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HER2CLIMB, 2020 NCT02614794 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | tucatinib plus trastuzumab plus capecitabine | placebo plus trastuzumab plus capecitabine | Patients with HER2-positive advanced breast cancer, had previously been treated with trastuzumab, pertuzumab, and trastuzumab emtansine. Patients with brain metastases were included unless they were in need of immediate local intervention (enrolled subsequently), or with untreated brain metastases larger than 2 cm in diameter could be enrolled with approval from the medical monitor. | 410 / 202 | low | conclusif |
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versus trastuzumab plus vinorelbine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
afatinib plus vinorelbine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LUX-Breast 1, 2016 NCT01125566 | RCT | la/mBC - HER2 positive - 2nd Line (L2) | afatinib plus vinorelbine | trastuzumab plus vinorelbine | Women with histollogically confirmed HER2 overexpressing and metastatic BC. Patient ad to have progressive disease following adjuvant treatment or first-line treatment for metastatic disease with trastuzumab. | 339 / 169 | some concern | inconclusive |
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