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 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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