Original Study| Volume 23, ISSUE 1, P38-44, January 2023

Racial Disparities in Clinical Outcomes on Investigator-Initiated Breast Cancer Clinical Trials at an Urban Medical Center

Published:October 13, 2022DOI:



      Black women are 40% more likely to die of breast cancer compared to White women. Inadequate representation of Black patients in clinical trials may contribute to health care inequity. We aimed to assess breast cancer clinical outcomes in Non-Hispanic Black (Black) versus Non-Hispanic White (White) women with metastatic breast cancer (MBC) enrolled on investigator-initiated clinical trials at Winship Cancer Institute at Emory University, given the significant number of patients from underrepresented minority groups seen at Winship.

      Materials and Methods

      Black and White women with MBC on investigator-initiated trials at Emory between 2009 and 2019 were retrospectively evaluated. Univariate analyses and multiple logistic regression models were used to assess clinical response and treatment toxicities. Differences in overall survival between groups was assessed using quantile analysis.


      Sixty-two women with MBC were included (66% White vs. 34% Black). Black patients had less clinical benefit from the trial therapy as only 57% had partial response or stable disease as best response compared to 78% of White women (P = .09). Quantile analysis showed significant difference in mean survival between Whites and Blacks by the end of follow up (64 vs. 38 months). There were no significant differences in toxicities between groups.


      Participation rates of Black women with MBC on investigator-initiated clinical trials at an urban cancer center were higher compared to key national trials. Black women had worse treatment response and survival. These results reinforce the need for assessment of tumor differences by ancestry and continued improvement in minority representation on clinical trials.


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        • Alshareef SH
        • Alsobaie NA
        • Aldeheshi SA
        • Alturki ST
        • Zevallos JC
        • Barengo NC.
        Association between race and cancer-related mortality among patients with colorectal cancer in the united states: a retrospective cohort study.
        Int J Environ Res Public Health. 2019; 16: 5-6
        • Singh GK
        • Jemal A.
        Socioeconomic and racial/ethnic disparities in cancer mortality, incidence, and survival in the united states, 1950-2014: over six decades of changing patterns and widening inequalities.
        J Environ Public Health. 2017; 20172819372
        • Soneji S
        • Tanner NT
        • Silvestri GA
        • Lathan CS
        • Black W.
        Racial and ethnic disparities in early-stage lung cancer survival.
        Chest. 2017; 152: 587-597
        • Kim A
        • Ashman P
        • Ward-Peterson M
        • Lozano JM
        • Barengo NC.
        Racial disparities in cancer-related survival in patients with squamous cell carcinoma of the esophagus in the US between 1973 and 2013.
        PLoS One. 2017; 12e0183782
        • Aizer AA
        • Wilhite TJ
        • Chen MH
        • et al.
        Lack of reduction in racial disparities in cancer-specific mortality over a 20-year period.
        Cancer. 2014; 120: 1532-1539
        • Stapleton SM
        • Oseni TO
        • Bababekov YJ
        • Hung YC
        • Chang DC.
        Race/ethnicity and age distribution of breast cancer diagnosis in the United States.
        JAMA Surg. 2018; 153: 594-595
        • Ries L
        • Harkins D
        • Krapcho M
        • et al.
        SEER Cancer Statistics Review, 1975-2003. National Cancer Institute, Bethesda, MD2006
        • Bauer KR
        • Brown M
        • Cress RD
        • Parise CA
        • Caggiano V.
        Descriptive analysis of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative invasive breast cancer, the so-called triple-negative phenotype: a population-based study from the California cancer Registry.
        Cancer. 2007; 109: 1721-1728
        • Kumar P
        • Aggarwal R.
        An overview of triple-negative breast cancer.
        Arch Gynecol Obstet. 2016; 293: 247-269
        • Dent R
        • Trudeau M
        • Pritchard KI
        • et al.
        Triple-negative breast cancer: clinical features and patterns of recurrence.
        Clin Cancer Res. 2007; 13 (Pt 1): 4429-4434
        • Dietze EC
        • Sistrunk C
        • Miranda-Carboni G
        • O'Regan R
        • Seewaldt VL
        Triple-negative breast cancer in African-American women: disparities versus biology.
        Nat Rev Cancer. 2015; 15: 248-254
        • Lee YT
        • Tan YJ
        • Oon CE.
        Molecular targeted therapy: Treating cancer with specificity.
        Eur J Pharmacol. 2018; 834: 188-196
        • Granier C
        • Karaki S
        • Roussel H
        • et al.
        [Cancer immunotherapy: Rational and recent breakthroughs].
        Rev Med Interne. 2016; 37: 694-700
        • Loree JM
        • Anand S
        • Dasari A
        • et al.
        Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018.
        JAMA Oncol. 2019; 5e191870
        • Nazha B
        • Mishra M
        • Pentz R
        • Owonikoko TK.
        Enrollment of racial minorities in clinical trials: old problem assumes new urgency in the age of immunotherapy.
        Am Soc Clin Oncol Educ Book. 2019; 39: 3-10
        • Chen Jr, MS
        • Lara PN
        • Dang JH
        • Paterniti DA
        • Kelly K
        Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.
        Cancer. 2014; 120 (Suppl): 1091-1096
        • Martin DN
        • Boersma BJ
        • Yi M
        • et al.
        Differences in the tumor microenvironment between African-American and European-American breast cancer patients.
        PLoS One. 2009; 4: e4531
        • Kinseth MA
        • Jia Z
        • Rahmatpanah F
        • et al.
        Expression differences between African American and Caucasian prostate cancer tissue reveals that stroma is the site of aggressive changes.
        Int J Cancer. 2014; 134: 81-91
        • Mitchell KA
        • Zingone A
        • Toulabi L
        • Boeckelman J
        • Ryan BM.
        Comparative transcriptome profiling reveals coding and noncoding RNA differences in NSCLC from African Americans and European Americans.
        Clin Cancer Res. 2017; 23: 7412-7425
        • Yasuda SU
        • Zhang L
        • Huang SM.
        The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies.
        Clin Pharmacol Ther. 2008; 84: 417-423
        • Bickell NA
        • Wang JJ
        • Oluwole S
        • et al.
        Missed opportunities: racial disparities in adjuvant breast cancer treatment.
        J Clin Oncol. 2006; 24: 1357-1362
        • DeSantis CE
        • Ma J
        • Gaudet MM
        • et al.
        Breast cancer statistics, 2019.
        CA Cancer J Clin. 2019; 69: 438-451
        • Hunt BR
        • Hurlbert MS.
        Black:white disparities in breast cancer mortality in the 50 largest cities in the United States, 2005-2014.
        Cancer Epidemiol. 2016; 45: 169-173
        • Tariq K
        • Latif N
        • Zaiden R
        • Jasani N
        • Rana F
        Breast cancer and racial disparity between Caucasian and African American women, part 1 (BRCA-1).
        Clin Adv Hematol Oncol. 2013; 11: 505-509
        • Yedjou CG
        • Sims JN
        • Miele L
        • et al.
        Health and racial disparity in breast cancer.
        Adv Exp Med Biol. 2019; 1152: 31-49
        • Foy KC
        • Fisher JL
        • Lustberg MB
        • Gray DM
        • DeGraffinreid CR
        • Paskett ED.
        Disparities in breast cancer tumor characteristics, treatment, time to treatment, and survival probability among African American and white women.
        NPJ Breast Cancer. 2018; 4: 7
        • Rupji M
        • Zhang X
        • Kowalski J.
        CASAS: Cancer survival analysis suite, a web based application.
        F1000Res. 2017; 6: 919
        • Huang Y.
        Quantile calculus and censored regression.
        Ann Stat. 2010; 38: 1607-1637
      1. QuickFacts. 2020. Available at:,claytoncountygeorgia,cobbcountygeorgia,fultoncountygeorgia,dekalbcountygeorgia,atlantacitygeorgia/PST045221. Accessed July 1, 2021.

        • Owonikoko TK
        • Busari AK
        • Kim S
        • et al.
        Race-, age-, and gender-based characteristics and toxicities of targeted therapies on phase I trials.
        Oncology. 2018; 95: 138-146
        • Salman A
        • Nguyen C
        • Lee YH
        • Cooksey-James T.
        A review of barriers to minorities' participation in cancer clinical trials: implications for future cancer research.
        J Immigr Minor Health. 2016; 18: 447-453
        • Schmotzer GL.
        Barriers and facilitators to participation of minorities in clinical trials.
        Ethn Dis. 2012; 22: 226-230
        • Regnante JM
        • Richie NA
        • Fashoyin-Aje L
        • et al.
        US cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials.
        J Oncol Pract. 2019; 15: e289-e299
        • Cooper LA
        • Roter DL
        • Johnson RL
        • Ford DE
        • Steinwachs DM
        • Powe NR.
        Patient-centered communication, ratings of care, and concordance of patient and physician race.
        Ann Intern Med. 2003; 139: 907-915
        • Hamel LM
        • Chapman R
        • Malloy M
        • et al.
        Critical shortage of African American medical oncologists in the United States.
        J Clin Oncol. 2015; 33: 3697-3700
        • Eggly S
        • Hamel LM
        • Heath E
        • et al.
        Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.
        BMC Cancer. 2017; 17: 807
        • Dawood S
        • Broglio K
        • Gonzalez-Angulo AM
        • Buzdar AU
        • Hortobagyi GN
        • Giordano SH.
        Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer.
        J Clin Oncol. 2008; 26: 4891-4898
        • Brewster AM
        • Chavez-MacGregor M
        • Brown P.
        Epidemiology, biology, and treatment of triple-negative breast cancer in women of African ancestry.
        Lancet Oncol. 2014; 15: e625-e634
        • Jiagge E
        • Jibril AS
        • Chitale D
        • et al.
        Comparative analysis of breast cancer phenotypes in African American, white American, and west versus East African patients: Correlation between African ancestry and triple-negative breast cancer.
        Ann Surg Oncol. 2016; 23: 3843-3849
        • Kohler BA
        • Sherman RL
        • Howlader N
        • et al.
        Annual report to the nation on the status of cancer, 1975-2011, featuring incidence of breast cancer subtypes by race/ethnicity, poverty, and state.
        J Natl Cancer Inst. 2015; 107: djv048
        • Abdou Y
        • Attwood K
        • Cheng TD
        • et al.
        Racial differences in CD8(+) T cell infiltration in breast tumors from Black and White women.
        Breast Cancer Res. 2020; 22: 62
        • Bhattarai S
        • Xia J
        • Wetherilt CS
        • et al.
        A multi-institutional study of racial differences in androgen receptor status among triple-negative breast cancers.
        J Clin Oncol. 2016; 34 (-1089): 1089
        • Sparano JA
        • Wang M
        • Zhao F
        • et al.
        Obesity at diagnosis is associated with inferior outcomes in hormone receptor-positive operable breast cancer.
        Cancer. 2012; 118: 5937-5946
        • Pajares B
        • Pollan M
        • Martin M
        • et al.
        Obesity and survival in operable breast cancer patients treated with adjuvant anthracyclines and taxanes according to pathological subtypes: a pooled analysis.
        Breast Cancer Res. 2013; 15: R105
        • Modi ND
        • Tan JQE
        • Rowland A
        • et al.
        The obesity paradox in early and advanced HER2 positive breast cancer: pooled analysis of clinical trial data.
        NPJ Breast Cancer. 2021; 7: 30
        • Pizzuti L
        • Marchetti P
        • Natoli C
        • et al.
        Fasting glucose and body mass index as predictors of activity in breast cancer patients treated with everolimus-exemestane: The EverExt study.
        Sci Rep. 2017; 7: 10597