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Phase III Trial of Doxorubicin, Cyclophosphamide, and Paclitaxel with Trastuzumab for HER-2+ Breast Cancer

The N9831 trial investigates the efficacy of adjuvant treatment with Doxorubicin and Cyclophosphamide (AC) followed by weekly Paclitaxel, with and without Trastuzumab, for women with HER-2 overexpressing, node-positive breast cancer. Central eligibility criteria for HER-2 testing, including HercepTest and FISH methods, were evaluated to ensure reliable patient selection. The trial aims to optimize treatment strategies and enhance outcomes for this patient population.

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Phase III Trial of Doxorubicin, Cyclophosphamide, and Paclitaxel with Trastuzumab for HER-2+ Breast Cancer

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  1. Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER‑2 Overexpressing Node-Positive Breast Cancer Breast Intergroup (N9831) Edith A. Perez, PI

  2. N9831: Intergroup Trial for Node , HER2  Breast Cancer Paclitaxel qw x 12 AC q3w x 4Paclitaxel qw x 12 H qw x 52 (Paclitaxel + H) qw x 12 H qw x 40 RT/Tam H= trastuzumab n= 3000 PI: Perez EA. NCCTG

  3. Her2 Eligibility Criteria for N9831 as Determined by Local Testing • HercepTest = 3+ • Other IHC test = >33% strongly positive (3+) • Vysis FISH = Her2:Cen17 > 2.0 • Oncor FISH = >5 copies Her2 gene

  4. Her2 Central Testing • Confirmatory central testing of first 100 patients by HercepTest and Vysis FISH • If >20% discrepancy between local and central Her2 status, then modify eligibility based on local results

  5. N9831: HER2 TestingResults • Results of central testing for 119 patients • Local testing methods (65 labs) included: • 50% (59/119) HercepTest • 43% (51/119) other IHC tests • 7% (9/119) FISH

  6. Comparison of Local/Central IHC Review • 74% (81/110) 3+ local IHC and 3+ central HercepTest • 75% (44/59) with 3+ by local HercepTest had 3+ by central HercepTest • 72% (37/51) with 3+ by other IHC had 3+ by central HercepTest

  7. Comparison of Local/Central FISH Review • 77% (7/9) with Her2 amp by local FISH had 3+ by central HercepTest • 67% (6/9) with Her2 amp by local FISH had amplification by central FISH

  8. HercepTest/FISH Central Review of 119 Specimens • 66% (79/119) amp by central FISH • 74% (88/119) 3+ by central IHC • 10% (9/88) were 3+ by central IHC and not amplified by central FISH

  9. HercepTest Comparison of Central HercepTest and Vysis FISH

  10. Summary of Central HercepTest and Vysis FISH Results • 90% (79/88) specimens 3+ on central HercepTest were amplified by central FISH • 100% (31/31) specimens 0,1+, 2+ on central HercepTest were not amplified by central FISH • 92% (110/119) concordance for central IHC and central FISH

  11. Proposed Modifications for N9831 • Register on trial if node-positive and 3+ IHC or Her2 amplified by local testing • Prior to completion of AC, central testing of specimen performed • If 3+ or amplified, randomize to 1 of 3 treatment arms • If not 3+ or amplified, cancel from study

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