Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

4382 - Preoperative Pembrolizumab (Pembro) with Radiation Therapy (RT) in Patients with Operable Triple-Negative Breast Cancer (TNBC)

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Heather McArthur

Citation

Annals of Oncology (2018) 29 (suppl_8): viii58-viii86. 10.1093/annonc/mdy270

Authors

H.L. McArthur1, R. Basho1, S. Shiao1, D. Park1, C. Dang1, S. Karlan1, S. Knott1, M. Mita2, C. Dilauro Abaya1, A.E. Giuliano1, F. Dadmanesh1, A. Ho3

Author affiliations

  • 1 Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 2 Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, 90048 90048 - Los Angeles/US
  • 3 Harvard University, Massachusetts General Hospital, 02114 - Boston/US
More

Resources

Abstract 4382

Background

Radiation therapy (RT) induces immune-mediated cell death. If administered pre-operatively, RT could also generate a rich supply of tumor antigens. The addition of PD-1 mediated checkpoint blockade to pre-operative RT could thus, generate robust anti-tumor immune responses, induce long-term tumor-specific memory, and ultimately, improve cure rates. This study aims to establish the safety of pre-operative pembrolizumab (pembro)-mediated immune modulation with a RT “boost” equivalent in patients with operable triple negative breast cancer (TNBC) for whom lumpectomy and adjuvant RT are planned (NCT03366844). Serial research biopsies will permit interrogation of conventional biomarkers including tumor infiltrating lymphocytes (TILs) and novel immune correlates as potential predictors of response to pembro alone versus pembro with RT.

Trial design

Women with operable, primary TNBC >2cm for whom breast-conserving therapy is planned are enrolled in this single-institution pilot study. Study treatment consists of 1 cycle of pre-operative pembro (200 mg IV) alone, followed 3 weeks later by a RT boost (24 Gy/3 fractions) to the primary breast tumor concurrently with pembro (+/- 5 days). Curative-intent, standard-of-care, neoadjuvant chemotherapy or breast-conserving surgery is then undertaken within 8 weeks of study enrollment (i.e. within 5 weeks of pembro #2). Adjuvant RT is administered per standard-of-care after surgery, but without a boost dose. Research blood and fresh tumor biopsies are obtained at baseline and after cycles 1 and 2 of pembro. Correlative analysis will include single-cell RNA sequencing of the tumor immune infiltrate and multispectral immunohistochemistry. Co-primary endpoints are: 1) safety/tolerability, as defined by the number of patients who do not necessitate a delay in standard-of-care chemotherapy or surgery and 2) change in TIL score. Secondary endpoints include safety/toxicity up to 19 weeks after study enrollment and disease-free survival.

Clinical trial identification

Legal entity responsible for the study

Heather McArthur.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

H.L. McArthur: Advisory boards: Amgen, Celgene, Immunomedics, Merck, OBI Pharma, Pfizer, Puma, Spectrum Pharmaceuticals, Syndax Pharmaceuticals, Roche, Peregrine, Calithera, Eli Lilly, TapImmune; Research support: Bristol-Myers Squibb, Eli Lilly, MedImmune, LLC/AstraZeneca, Merck. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.