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Node-negative, small, HER2-positive breast cancer
Source: Breast Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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There are no studies comparing different regimens in patients with node-negative, small, HER2-positive breast tumors. The following two large single-arm studies demonstrated outcomes that appear to be superior to previous results in similar patients who did not receive adjuvant therapy.
Evidence (combination regimens for node-negative, small, HER2-positive tumors):
The single-arm Adjuvant Paclitaxel and Trastuzumab (APT) trial (NCT00542451) evaluated a non–anthracycline-containing regimen, paclitaxel and trastuzumab. The trial enrolled 410 women with node-negative, small (≤3 cm), HER2-positive tumors.[144]
The single-arm Adjuvant Paclitaxel and Trastuzumab (APT) trial (NCT00542451) evaluated a non–anthracycline-containing regimen, paclitaxel and trastuzumab. The trial enrolled 410 women with node-negative, small (≤3 cm), HER2-positive tumors.[144]
After 6.5 years of follow-up, the DFS rate was 93% (95% CI, 90.4%–96.2%).[144][Level of evidence C2]
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The single-arm Adjuvant Paclitaxel and Trastuzumab (APT) trial (NCT00542451) evaluated a non–anthracycline-containing regimen, paclitaxel and trastuzumab. The trial enrolled 410 women with node-negative, small (≤3 cm), HER2-positive tumors.[144]
The 10-year DFS rate was 91.3% (95% CI, 88.3%–94.4%).[145]
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The ATEMPT trial (NCT01853748) compared paclitaxel and trastuzumab with T-DM1 in patients with node-negative HER2-positive tumors measuring 2 cm or smaller (patients with a single micrometastatic node were eligible). The goals of the trial were to determine if T-DM1 produced fewer clinically relevant toxicities and was associated with an acceptable 3-year IDFS rate. The trial randomly assigned 383 patients to the T-DM1 arm and 114 patients to the paclitaxel and trastuzumab arm.[146]
The ATEMPT trial (NCT01853748) compared paclitaxel and trastuzumab with T-DM1 in patients with node-negative HER2-positive tumors measuring 2 cm or smaller (patients with a single micrometastatic node were eligible). The goals of the trial were to determine if T-DM1 produced fewer clinically relevant toxicities and was associated with an acceptable 3-year IDFS rate. The trial randomly assigned 383 patients to the T-DM1 arm and 114 patients to the paclitaxel and trastuzumab arm.[146]
Although the types of toxicities differed in the two treatment arms, the total number of clinically relevant toxicities was nearly identical (46% in the T-DM1 arm vs. 47% in the paclitaxel and trastuzumab arm; P = .83). However, patients who received T-DM1 reported more favorable outcomes during treatment.
The ATEMPT trial (NCT01853748) compared paclitaxel and trastuzumab with T-DM1 in patients with node-negative HER2-positive tumors measuring 2 cm or smaller (patients with a single micrometastatic node were eligible). The goals of the trial were to determine if T-DM1 produced fewer clinically relevant toxicities and was associated with an acceptable 3-year IDFS rate. The trial randomly assigned 383 patients to the T-DM1 arm and 114 patients to the paclitaxel and trastuzumab arm.[146]
The 3-year IDFS rate for patients who received T-DM1 was 97.8% (95% CI, 96.3%–99.3%), which exceeded the protocol-specified rate of 95% to reject the null hypothesis (P = .0001).[146][Level of evidence C1] Results were similar at 5 years.[147]
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Preserved source evidence · Not medical advice