Gretchen Kimmick

Overview:

Breast cancer; treatment of breast cancer; management of menopausal symptoms in breast cancer survivors; survivorship issues after breast cancer; supportive care in managment of cancer patients; breast cancer and treatment of cancer in older persons; diagnosis and management of cancer in underserved populations.

Positions:

Professor of Medicine

Medicine, Medical Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 1989

Wake Forest University

M.S. 2000

Wake Forest University

Medical Resident, Medicine

University of Florida

Fellow in Oncology, Medicine

North Carolina Baptist Hospital

Grants:

A Phase II Study of Neratinib in Metastatic HER2 Non-amplified by HER2 Mutant Breast Cancer

Administered By
Duke Cancer Institute
Role
Principal Investigator
Start Date
End Date

Publications:

Patient-reported outcomes in the Translational Breast Cancer Research Consortium.

Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.
Authors
Bowen, DJ; Shinn, EH; Gregrowski, S; Kimmick, G; Dominici, LS; Frank, ES; Smith, KL; Rocque, G; Ruddy, KJ; Pollastro, T; Melisko, M; Ballinger, TJ; Fayanju, OM; Wolff, AC
MLA Citation
Bowen, Deborah J., et al. “Patient-reported outcomes in the Translational Breast Cancer Research Consortium..” Cancer, Nov. 2019. Pubmed, doi:10.1002/cncr.32615.
URI
https://scholars.duke.edu/individual/pub1421501
PMID
31743427
Source
pubmed
Published In
Cancer
Published Date
DOI
10.1002/cncr.32615

A feasible and acceptable multicultural psychosocial intervention targeting symptom management in the context of advanced breast cancer.

OBJECTIVE: Advanced breast cancer patients around the world experience high symptom burden (ie, distress, pain, and fatigue) and are in need of psychosocial interventions that target symptom management. This study examined the feasibility, acceptability, and engagement of a psychosocial intervention that uses cognitive-behavioral strategies along with mindfulness and values-based activity to enhance patients' ability to manage symptoms of advanced disease in a cross-cultural setting (United States and Singapore). Pre-treatment to post-treatment outcomes for distress, pain, and fatigue were compared between intervention recipients and waitlisted controls. METHODS: A pilot randomized controlled trial included women with advanced breast cancer (N = 85) that were recruited in the United States and Singapore. Participants either received the four session intervention or were put on a waitlist. Descriptive statistics and effect size of symptom change were calculated. RESULTS: The psychosocial intervention was found to be feasible as indicated through successful trial accrual, low study attrition (15% ), and high intervention adherence (77% completed all sessions). Acceptability (ie, program satisfaction and cultural sensitivity) and engagement to the study intervention (ie, practice of skills taught) were also high. Anxiety, depression, and fatigue scores remained stable or improved among intervention participants while the same symptoms worsened in the control group. In general, effect sizes are larger in the US sample compared with the Singapore sample. CONCLUSIONS: The cognitive-behavioral, mindfulness, and values-based intervention is feasible, acceptable, and engaging for advanced breast cancer patients in a cross-cultural setting and has potential for efficacy. Further larger-scaled study of intervention efficacy is warranted.
Authors
Teo, I; Vilardaga, JP; Tan, YP; Winger, J; Cheung, YB; Yang, GM; Finkelstein, EA; Shelby, RA; Kamal, AH; Kimmick, G; Somers, TJ
MLA Citation
URI
https://scholars.duke.edu/individual/pub1421436
PMID
31703146
Source
pubmed
Published In
Psychooncology
Published Date
DOI
10.1002/pon.5275

Decreasing incidence of upper age restriction enrollment criteria among cancer clinical trials.

BACKGROUND: Age disparities among cancer clinical trial participants are pervasive and worsening over time. Identification of factors associated with age disparities is critical to improve enrollment of older patients on trials. The incidence and impact of trial eligibility criteria that exclude patients on the basis of age remains opaque. METHODS: ClinicalTrials.gov was queried for completed oncologic randomized controlled trials (RCTs). Phase 3 RCTs assessing a therapeutic intervention among adult cancer patients were included. Trial eligibility criteria were assessed using the ClinicalTrials.gov website as well as trial publications and protocol documentation. RESULTS: Seven hundred and forty-two trials met inclusion criteria, with a total combined enrollment of 449,720 patients. Upper age restriction enrollment criteria were identified for 10.1% of RCTs; the median age cutoff for restricted trials was 72 years (interquartile range 70-80 years). Linear regression modeling revealed decreasing incidence of age restriction criteria over time, at a rate of -1.1% annually (p = .03); trials initiating enrollment in 2002-2005, for example, had a 16.1% rate of age-restrictive eligibility criteria, compared with 7.6% for trials initiating enrollment in 2010-2014. CONCLUSION: Use of eligibility criteria that explicitly exclude patients on the basis of age appears to be decreasing with time. Future efforts should aim to better characterize the relationship between eligibility criteria (such as those that exclude patients on the basis of specific organ function) and their association with age disparities among enrolled patients.
Authors
Ludmir, EB; Subbiah, IM; Mainwaring, W; Miller, AB; Lin, TA; Jethanandani, A; Espinoza, AF; Mandel, JJ; Fang, P; Smith, BD; Smith, GL; Pinnix, CC; Sedrak, MS; Kimmick, GG; Stinchcombe, TE; Jagsi, R; Thomas, CR; Fuller, CD; VanderWalde, NA
MLA Citation
Ludmir, Ethan B., et al. “Decreasing incidence of upper age restriction enrollment criteria among cancer clinical trials..” J Geriatr Oncol, Nov. 2019. Pubmed, doi:10.1016/j.jgo.2019.11.001.
URI
https://scholars.duke.edu/individual/pub1421647
PMID
31711757
Source
pubmed
Published In
J Geriatr Oncol
Published Date
DOI
10.1016/j.jgo.2019.11.001

Arti Hurria, M.D.: A tribute to her shining legacy in the Alliance for Clinical Trials in Oncology.

Authors
Alliance Cancer in the Older Adult Committee,; Adjei, A; Buckner, JC; Cathcart-Rake, E; Chen, H; Cohen, HJ; Dao, D; De Luca, J-E; Feliciano, J; Freedman, RA; Goldberg, RM; Hopkins, J; Hubbard, J; Jatoi, A; Karuturi, M; Kemeny, M; Kimmick, GG; Klepin, HD; Krok-Schoen, JL; Lafky, JM; Le-Rademacher, JG; Li, D; Lichtman, SM; Maggiore, R; Mandelblatt, J; Morrison, VA; Muss, HB; Ojelabi, MO; Sedrak, MS; Subbiah, N; Sun, V; Tuttle, S; VanderWalde, N; Wildes, T; Wong, ML; Woyach, J
MLA Citation
Alliance Cancer in the Older Adult Committee, Jennifer, et al. “Arti Hurria, M.D.: A tribute to her shining legacy in the Alliance for Clinical Trials in Oncology..” J Geriatr Oncol, June 2019. Pubmed, doi:10.1016/j.jgo.2019.05.011.
URI
https://scholars.duke.edu/individual/pub1393270
PMID
31201095
Source
pubmed
Published In
J Geriatr Oncol
Published Date
DOI
10.1016/j.jgo.2019.05.011

Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer.

Purpose: Based on promising preclinical data, we conducted a single-arm phase II trial to assess the clinical benefit rate (CBR) of neratinib, defined as complete/partial response (CR/PR) or stable disease (SD) ≥24 weeks, in HER2mut nonamplified metastatic breast cancer (MBC). Secondary endpoints included progression-free survival (PFS), toxicity, and circulating tumor DNA (ctDNA) HER2mut detection.Experimental Design: Tumor tissue positive for HER2mut was required for eligibility. Neratinib was administered 240 mg daily with prophylactic loperamide. ctDNA sequencing was performed retrospectively for 54 patients (14 positive and 40 negative for tumor HER2mut).Results: Nine of 381 tumors (2.4%) sequenced centrally harbored HER2mut (lobular 7.8% vs. ductal 1.6%; P = 0.026). Thirteen additional HER2mut cases were identified locally. Twenty-one of these 22 HER2mut cases were estrogen receptor positive. Sixteen patients [median age 58 (31-74) years and three (2-10) prior metastatic regimens] received neratinib. The CBR was 31% [90% confidence interval (CI), 13%-55%], including one CR, one PR, and three SD ≥24 weeks. Median PFS was 16 (90% CI, 8-31) weeks. Diarrhea (grade 2, 44%; grade 3, 25%) was the most common adverse event. Baseline ctDNA sequencing identified the same HER2mut in 11 of 14 tumor-positive cases (sensitivity, 79%; 90% CI, 53%-94%) and correctly assigned 32 of 32 informative negative cases (specificity, 100%; 90% CI, 91%-100%). In addition, ctDNA HER2mut variant allele frequency decreased in nine of 11 paired samples at week 4, followed by an increase upon progression.Conclusions: Neratinib is active in HER2mut, nonamplified MBC. ctDNA sequencing offers a noninvasive strategy to identify patients with HER2mut cancers for clinical trial participation. Clin Cancer Res; 23(19); 5687-95. ©2017 AACR.
Authors
Ma, CX; Bose, R; Gao, F; Freedman, RA; Telli, ML; Kimmick, G; Winer, E; Naughton, M; Goetz, MP; Russell, C; Tripathy, D; Cobleigh, M; Forero, A; Pluard, TJ; Anders, C; Niravath, PA; Thomas, S; Anderson, J; Bumb, C; Banks, KC; Lanman, RB; Bryce, R; Lalani, AS; Pfeifer, J; Hayes, DF; Pegram, M; Blackwell, K; Bedard, PL; Al-Kateb, H; Ellis, MJC
MLA Citation
Ma, Cynthia X., et al. “Neratinib Efficacy and Circulating Tumor DNA Detection of HER2 Mutations in HER2 Nonamplified Metastatic Breast Cancer..” Clin Cancer Res, vol. 23, no. 19, Oct. 2017, pp. 5687–95. Pubmed, doi:10.1158/1078-0432.CCR-17-0900.
URI
https://scholars.duke.edu/individual/pub1264650
PMID
28679771
Source
pubmed
Published In
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Volume
23
Published Date
Start Page
5687
End Page
5695
DOI
10.1158/1078-0432.CCR-17-0900