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Cancer Prevention Research
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Research Article

Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study

Soley Bayraktar, Sema Baghaki, Jimin Wu, Diane D. Liu, Angelica M. Gutierrez-Barrera, Therese B. Bevers, Vicente Valero, Nour Sneige and Banu K. Arun
Soley Bayraktar
1Division of Medical Oncology and Hematology, Department of Medicine, Biruni University School of Medicine, Istanbul, Turkey.
2Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Sema Baghaki
2Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for Sema Baghaki
Jimin Wu
3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Diane D. Liu
3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Angelica M. Gutierrez-Barrera
2Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Therese B. Bevers
4Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Vicente Valero
2Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Nour Sneige
5Department of Cytopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Banu K. Arun
2Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • For correspondence: barun@mdanderson.org
DOI: 10.1158/1940-6207.CAPR-20-0095 Published September 2020
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Abstract

In preclinical studies, celecoxib has been associated with reduced risk of breast cancer. In this study, the aim was to assess the biomodulatory effect of celecoxib on blood and benign breast tissue biomarkers in women at increased risk for breast cancer. Women at increased risk for breast cancer [5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma in situ, or previous estrogen receptor (ER)-negative breast cancer] were treated with celecoxib at 400 mg orally twice daily for 6 months. Participants underwent random periareolar fine needle aspiration and blood draw at baseline and at 6 months for analysis of biomarkers: serum levels of insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER; as well as cytology. Forty-nine patients were eligible for analysis. Median IGFBP-1 levels increased significantly from 6.05 ng/mL at baseline to 6.93 ng/mL at 6 months (P = 0.04), and median IGFBP-3 levels decreased significantly from 3,593 ng/mL to 3,420 ng/mL (P = 0.01). We also detected favorable changes in cytology of 52% of tested sites after 6 months of celecoxib therapy. No changes in tissue Ki-67 and ER expression levels were observed. No grade 3 or 4 toxicity was recorded. Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial. A phase IIb placebo-controlled study with celecoxib could be considered for women at increased risk for breast cancer.

Footnotes

  • Cancer Prev Res 2020;13:795–802

  • Received February 27, 2020.
  • Revision received April 1, 2020.
  • Accepted June 2, 2020.
  • Published first June 8, 2020.
  • ©2020 American Association for Cancer Research.
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Cancer Prevention Research: 13 (9)
September 2020
Volume 13, Issue 9
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Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study
Soley Bayraktar, Sema Baghaki, Jimin Wu, Diane D. Liu, Angelica M. Gutierrez-Barrera, Therese B. Bevers, Vicente Valero, Nour Sneige and Banu K. Arun
Cancer Prev Res September 1 2020 (13) (9) 795-802; DOI: 10.1158/1940-6207.CAPR-20-0095

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Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study
Soley Bayraktar, Sema Baghaki, Jimin Wu, Diane D. Liu, Angelica M. Gutierrez-Barrera, Therese B. Bevers, Vicente Valero, Nour Sneige and Banu K. Arun
Cancer Prev Res September 1 2020 (13) (9) 795-802; DOI: 10.1158/1940-6207.CAPR-20-0095
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