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Poster display session

1747 - Phase II study of gemcitabine, trastuzumab, and pertuzumab for HER2-positive metastatic breast cancer after prior pertuzumab-based therapy

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Neil Iyengar

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

N.M. Iyengar, L.M. Smyth, D. Lake, A. Gucalp, J.C. Singh, T.A. Traina, P. Defusco, M.N. Dickler, M.N. Fornier, S.B. Goldfarb, K. Jhaveri, S. Modi, T. Troso-Sandoval, K. Jack, G. Ulaner, M. Jochelson, J. Baselga, L. Norton, C.A. Hudis, C.T. Dang

Author affiliations

  • Medicine, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
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Resources

Abstract 1747

Background

The combination of taxanes with trastuzumab (H) and pertuzumab (P) for first line treatment of HER2-positive metastatic breast cancer (MBC) is associated with improved progression-free (PFS) and overall survival (OS). Treatment per physician’s choice with anti-HER2 therapy after second line therapy is associated with a median PFS of 3 months. While continued use of H in therapeutic combinations after progression on H-based therapy is standard, the efficacy of continuing HP-based treatment after progression on P-based therapy is unknown.

Methods

This is a single arm phase II trial of gemcitabine (G) with HP. Eligible patients (pts) had HER2-positive (IHC 3+ or FISH ≥ 2.0) MBC with prior HP-based treatment and ≤ 3 prior chemotherapies. Pts received G (1200 mg/m2) on days 1 and 8 of a q 3 week (w) cycle, and H (8 mg/kg load → 6 mg/kg) and P (840 mg load → 420 mg) q3w. The primary endpoint is PFS at 3 months. Secondary endpoints include OS, safety and tolerability. An exploratory endpoint is to compare PFS by RECIST criteria versus 18-F FDG-PET response criteria. The study therapy will be considered successful if at least 27/45 (60%) patients are progression free at 3 months.

Results

As of 27 April 2017, 45 of 45 pts are enrolled; 39 are evaluable at 3 months and 6 have not had 3-month evaluation. At 3 months, 30/39 (77%) are progression free (1 CR, 8 PR, 21 SD); 9 pts progressed. There are no cardiac or febrile neutropenic events to date. 4 pts required G dose reduction (3 grade 3 neutropenia and 1 grade 3 vomiting) and the study was amended to lower initial G dose to 1000 mg/m2.

Conclusions

The preliminary 3 month-PFS is 77% in evaluable pts (95% CI 62% to 87%). The updated 3 month-PFS results will be presented. Continuation of P beyond progression is associated with apparent clinical benefit. A randomized trial is justified to confirm this clinically important observation.

Clinical trial identification

NCT02252887

Legal entity responsible for the study

Memorial Sloan Kettering Cancer Center

Funding

Genentech/Roche

Disclosure

All authors have declared no conflicts of interest.

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