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Breast Intergroup (N9831) Edith A. Perez, PI

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.

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Breast Intergroup (N9831) Edith A. Perez, PI

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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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