Program Official

Principal Investigator

Electra D. Paskett

Awardee Organization

Alliance Nctn Foundation
United States

Fiscal Year

2025

Activity Code

UG1

Early Stage Investigator Grants (ESI)

Not Applicable

Project End Date

7/31/2026

NIH RePORTER

For more information, see NIH RePORTER Project 3UG1CA189823-11S3

Alliance NCORP Research Base

The Alliance for Clinical Trials in Oncology (Alliance), one of five National Clinical Trials Network groups, serves as the parent organization for the Alliance NCI Community Oncology Research Program (NCORP) Research Base (Alliance NCORP). The Alliance NCORP conducts interventional and observational clinical and translational research as well as database studies – all of which address important questions relevant to cancer prevention, symptom control, and cancer care delivery. In addition, the Alliance NCORP conducts clinically important quality of life studies that are embedded within cancer treatment trials. Alliance committees and protocols focus on all patients at risk for or diagnosed with cancer, and on building strong collegial relationships across all NCORP Community sites. The Alliance NCORP committee membership includes rich representation from both community-based and academic medical centers, as well as patient representatives thus generating research results relevant to cancer patients across the United States. The Alliance NCORP also emphasizes mentorship and training of junior investigators. Over this past grant cycle, i.e., since August 2014, the Alliance NCORP has published over 240 manuscripts and abstracts. This work has included practice-changing research in such areas as the prevention of chemotherapy-induced nausea and vomiting, the prevention of skeletal-related events from osseous metastases, the management of brain metastases, and the integration of patient-reported outcomes into cancer clinical trials. The Alliance NCORP conducts translational research that requires the collection of tumor tissue, premalignant tissue samples, blood, and other human biospecimens; and shares data and biospecimens for pooled analyses and other scientific collaborations. These biospecimens create an invaluable repository for understanding clinical observations from a mechanistic standpoint. The Alliance NCORP also collaborates broadly with other NCI- funded investigators and consortia, as well as with investigators supported through non-NCI sources. This practice-changing research and the scientific questions answered by the Alliance NCORP provide meaningful and innovative contributions to clinical and translational oncology, which can be conducted only within a publicly- funded research network.

Publications

Azim HA Jr, Niman SM, Partridge AH, Demeestere I, Ruggeri M, Colleoni M, Saura C, Shimizu C, Saetersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruíz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Klar NJ, Spanic T, Ruddy K, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, Peccatori FA. Fertility Preservation and Assisted Reproduction in Patients With Breast Cancer Interrupting Adjuvant Endocrine Therapy to Attempt Pregnancy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2024 Aug 10;42(23):2822-2832. Epub 2024 May 29. PMID: 38810178
Wolfson JA, Grimes AC, Nuño MM, Ramakrishnan S, Dickens DS, Roth ME, Woods W, Adams KS, Alabi T, Beauchemin M, Levine JM, Scialla M, Boayue KB, Kerber CL, Ponce O, Vargas S, Chang GJ, Stock W, Hershman D, Curran E, Advani A, O'Dwyer K, Luger S, Liu JJ, Freyer DR, Sung L, Parsons SK. Guideline-concordant treatment among adolescents and young adults with acute lymphoblastic leukemia. JNCI cancer spectrum. 2025 Apr 30;9. (3). PMID: 40238217
Partridge AH, Niman SM, Ruggeri M, Peccatori FA, Azim HA Jr, Colleoni M, Saura C, Shimizu C, Sætersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruíz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Smith KL, Ferreiro T, Ribi K, Ruddy K, Kammler R, El-Abed S, Viale G, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, International Breast Cancer Study Group, POSITIVE Trial Collaborators, Azim HA Jr, Peccatori F, Ribi K, Abi-Khattar C, Amant F, Barbro Sætersdal A, Bjelic-Radisic V, Blacher L, Borges V, Borrego MR, Borstnar S, Cardoso F, Colleoni M, Demeestere I, Di Leo A, Eon Lee J, Ferreiro T, Gelber R, Gelmon K, Hiltbrunner A, El-Abed S, Ignatiadis M, Jani P, Kammler R, Walshe JM, Kroep J, Loi S, Mailliez A, Mavroudis D, Moore H, Naughton M, Niman SM, Paluch-Shimon S, Rabaglio M, Regan MM, Roschitzki H, Ruddy K, Ruepp B, Ruggeri M, Saunders C, Saura C, Shaw H, Shimizu C, Smith KL, Spanic T, Susnjar S, Symmans F, Viale G, Boyle F, Jerusalem G, Stahel R, Aebi S, Baas P, McGregor K, Peters S, Popat S, Rosell R, Achille G, Adam S, Alleman S, Campus I, Carrer-Wagner A, Celotto D, Comune C, Fournarakou M, Frapolli M, Gasca A, Giacomelli N, Hahn B, Karagol R, Keglowich L, Maddox C, Maibach R, Marbot M, Mathys M, Pardo Contreras M, Nesa M, Nobs L, Pfister R, Roux S, Rugiati E, Sanchez-Hohl M, Schneider M, Schroeder J, Sicher P, Troesch S, Wagner M, Weber M, Wenger M, Wiedemann M, Wyss F, Zenklusen I, Zigomo I, Züger D, Bouzan C, Cole B, Gelber S, Huang H, Mahoney C, Northrop L, Sun Z, Blackwell M, Harrison D, Fischer S, Kassab G, Mundy L, Narayanan D, Palermo V, Polizzi D, Scott K, Starkweather R, Swick-Jemison J, Veira Y, Weinbaum D, Bernhard J, Andrighetto S, Ciocca F, Dell'Orto P, Russo L, Benini E, Arrigoni L, Schina I, Dechene J, Rothé F, Maetens M, Goldhirsch A, Korde L, Piccart M, Schmitz S, El-Abed S, De Swert H, Jooris M, Leemans J, Questiaux G, Beaupère L, Straehle C, Mooney M, Colleoni M, Artioli F, Cretella E, Gallerani E, Sanna G, Chini C, Ferro A, Spazzapan S, Seles E, De Giorgi U, Tausch C, Rossi L, Rabaglio M, Zaman K, Vetter M, Dedes K, Bodmer A, Leo C, Riniker S, Borner M, Membrez V, Amant F, Gombos A, Jerusalem G, Quaghebeur C, Borstnar S, El Saghir NS, Saura C, Iranzo V, Perelló A, Luna Barrera AM, González X, Cardoso F, Guerra J, Sanchez Henarejos P, Virizuela JA, López R, Andrés R, Kataoka A, Takei J, Nakamura S, Shien T, Tugawa K, Bando H, Kawashima M, Tokunaga E, Tada H, Kawano J, Masuda N, Yoshida M, Takahashi M, Tamura K, Egawa C, Shimuzu C, Partridge AH, Dilawari AA, Flaum E, McAndrew PF, Casteel CM, Smith KL, Al Baghdadi T, Cigler T, Sparano JA, DiBella N, Masters GA, Anderson DM, Reeder-Hayes KE, Crawford J, Radford JE, Schwartz GN, Ruiz Dayao Z, Beck AC, William IJ, Warner E, Gelmon KA, Webster M, Haq R, Elser C, Pavic M, Desbiens C, Barbro Sætersdal A, Kroep JR, Mailliez A, Rousset-Jablonski C, Debled M, Borges VF, Sanft TB, Yung RL, Ángel García-Sáenz J, Ruiz-Borrego M, José Bermejo Pérez M, Illarramendi JJ, Del Barco S, Walshe JM, Korpanty G, Keane M, Kennedy J, Saunders C, Bjelic-Radisic V, Greil R, Czech T, Lee JE, Jeong Kim H, Susnjar S, Ballinger TJ, Wapnir IL, Borges VF, Meisel JL, Steen PD, Mavroudis D, Kaufman B, Vici P. Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer. The New England journal of medicine. 2023 May 4;388(18):1645-1656. PMID: 37133584
Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM evidence. 2022 Sep;1. (9). Epub 2022 Aug 18. PMID: 36908314
Stearns V, Jegede OA, Chang VT, Skaar TC, Berenberg JL, Nand R, Shafqat A, Jacobs NL, Luginbuhl W, Gilman P, Benson AB 3rd, Goodman JR, Buchschacher GL Jr, Henry NL, Loprinzi CL, Flynn PJ, Mitchell EP, Fisch MJ, Sparano JA, Wagner LI. A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms: Results from ECOG-ACRIN E1Z11. Clinical cancer research : an official journal of the American Association for Cancer Research. 2024 Jul 1;30(13):2709-2718. PMID: 38640040
Dressler EV, Pugh SL, Gunn HJ, Unger JM, Zahrieh DM, Snavely AC. Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):56-64. PMID: 39989035
Hu P, Steingrimsson JA, Cole E, Cormack J, Dunn BK, Gatsonis C, Lee C, Li N, Pisano ED, He J, Kramer BS. Design considerations and challenges in the CHinA National CancEr Screening (CHANCES) trial and Tomosynthesis Mammographic Imaging Screening Trial (TMIST). Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):42-48. PMID: 39989037
Bandos H, Torres-Saavedra PA, Culakova E, Gunn HJ, Lee MK, Duan F, Cecchini RS, Unger JM, Dueck AC, Steingrimsson JA. Best practices and pragmatic approaches for patient-reported outcomes and quality of life measures in cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):14-21. PMID: 39989038
Wolfson JA, Grimes AC, Nuno M, Kerber CL, Ramakrishnan S, Beauchemin M, Dickens D, Levine JM, Roth ME, Scialla M, Woods W, Vargas S, Boayue KB, Chang GJ, Stock W, Hershman D, Curran E, Advani A, O'Dwyer K, Luger S, Liu JJ, Freyer DR, Sung L, Parsons SK. Characteristics of Health Care Settings Where Adolescents and Young Adults Receive Care for ALL. JCO oncology practice. 2024 Apr;20(4):491-502. Epub 2024 Jan 22. PMID: 38252911
Monge C, Eldridge L, Pearlman PC, Venkatesh V, Tregear M, Loehrer PJ Sr, Galassi A, Gopal S, Ginsburg O. Global perspectives on patient-centered outcomes: advancing patient-centered cancer clinical trials globally. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):35-41. PMID: 39989041
Unger JM, Mazza GL, Elsaid MI, Duan F, Dressler EV, Snavely AC, Enserro DM, Pugh SL. When to adjust for multiplicity in cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):3-9. PMID: 39989044
Enserro DM, Gunn HJ, Elsaid MI, Duan F, Pugh SL. Challenges to and considerations of designing cancer prevention trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):49-55. PMID: 39989045
Suddala S, O'Connell N, D'Agostino R Jr, Ladd A, Lucas AR, Jordan JH, Salloum FN, Ky B, Hackney MH, Hundley WG. Reduced Thoracic Aortic Distensibility Upon Breast Cancer Diagnosis (WF-97415 and WF-98213). JACC. CardioOncology. 2023 Mar 7;5(5):704-706. doi: 10.1016/j.jaccao.2022.11.018. eCollection 2023 Oct. PMID: 37969653
Kircher S, Duan F, An N, Gareen IF, Sicks JD, Sadigh G, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Park ER, Wagner LI, Carlos RC. Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer. JAMA network open. 2024 Jan 2;7(1):e2350844. PMID: 38194233
Delahanty LM, Wadden TA, Goodwin PJ, Alfano CM, Thomson CA, Irwin ML, Neuhouser ML, Crane TE, Frank E, Spears PA, Gillis BP, Hershman DL, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hudis C, Winer EP, A Carey L, Partridge AH, Ligibel JA. The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. Obesity (Silver Spring, Md.). 2022 Jan;30(1):28-38. PMID: 34932888
Cathcart-Rake E, Novotny P, Leon-Ferre R, Le-Rademacher J, Storrick EM, Adjei AA, Terstriep S, Glaser R, Giuliano A, Mitchell WR, Page S, Austin C, Deming RL, Ferreira MA, Lafky JM, Birrell SN, Loprinzi CL. A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021 Jan;29(1):387-396. Epub 2020 May 6. PMID: 32372176
Ligibel JA, Barry WT, Alfano C, Hershman DL, Irwin M, Neuhouser M, Thomson CA, Delahanty L, Frank E, Spears P, Paskett ED, Hopkins J, Bernstein V, Stearns V, White J, Hahn O, Hudis C, Winer EP, Wadden TA, Goodwin PJ. Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer (Alliance A011401): study design. NPJ breast cancer. 2017 Sep 21;3:37. doi: 10.1038/s41523-017-0040-8. eCollection 2017. PMID: 28948213
Mazza GL, Culakova E, Enserro DM, Dignam JJ, Unger JM. Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):22-29. PMID: 39989043
Sadigh G, Duan F, An N, Gareen ID, Sicks J, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Taylor MA, Park E, Wagner LI, Kircher SM, Carlos RC. Financial Hardship Among Patients With Early-Stage Colorectal Cancer. JAMA network open. 2024 Sep 3;7(9):e2431967. PMID: 39287948
Carlos RC, Sicks JD, Chang GJ, Lyss AP, Stewart TL, Sung L, Weaver KE. Capacity for Cancer Care Delivery Research in National Cancer Institute Community Oncology Research Program Community Practices: Availability of Radiology and Primary Care Research Partners. Journal of the American College of Radiology : JACR. 2017 Dec;14(12):1530-1537. Epub 2017 Oct 19. PMID: 29055605
Makhlin I, Demissei BG, D'Agostino R, Hundley WG, Baleanu-Gogonea C, Wilcox NS, Chen A, Smith AM, O'Connell NS, Januzzi JL, Lesser GJ, Scherrer-Crosbie M, Ibáñez B, Tang WHW, Ky B. Statins Do Not Significantly Affect Oxidative Nitrosative Stress Biomarkers in the PREVENT Randomized Clinical Trial. Clinical cancer research : an official journal of the American Association for Cancer Research. 2024 Jun 3;30(11):2370-2376. PMID: 38573708
McLouth LE, Zheng Y, Smith S, Hodi FS, Rao UN, Cohen GI, Amatruda TT, Dakhil SR, Curti BD, Nakhoul I, Chandana SR, Bane CL, Marinier DE, Lee SJ, Sondak VK, Kirkwood JM, Tarhini AA, Wagner LI. Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2023 Jan;32(1):183-196. Epub 2022 Aug 27. PMID: 36029412
Cathcart-Rake EJ, Zemla T, Jatoi A, Weaver KE, Neuman H, Kazak AE, Carlos R, Gansauer L, Unger JM, Pajewski NM, Kamen C. Acquisition of sexual orientation and gender identity data among NCI Community Oncology Research Program practice groups. Cancer. 2019 Apr 15;125(8):1313-1318. Epub 2018 Dec 18. PMID: 30561776
Partridge AH, Niman SM, Ruggeri M, Peccatori FA, Azim HA Jr, Colleoni M, Saura C, Shimizu C, Sætersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Borrego MR, Moore HC, Saunders C, Cardoso F, Susnjar S, Bjelic-Radisic V, Smith KL, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O. Who are the women who enrolled in the POSITIVE trial: A global study to support young hormone receptor positive breast cancer survivors desiring pregnancy. Breast (Edinburgh, Scotland). 2021 Oct;59:327-338. Epub 2021 Aug 3. PMID: 34390999

Clinical Trials

Study Name	Clinical Trial ID
Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer	NCT02598726
Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin	NCT03122886
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma	NCT01781468
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program	NCT05008848
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation	NCT04711109
Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection	NCT03927027
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection	NCT05334069
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer	NCT03857620
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers	NCT02349412
Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment	NCT01573442
Collection of Patient-Reported Symptoms and Performance Status Via the Internet	NCT00417040
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy	NCT04989504
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	NCT02229539
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer	NCT04600336
Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy	NCT03578081
Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients	NCT04939090
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions	NCT04549571
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy	NCT04379570
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer	NCT04533451
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial	NCT05379153
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease	NCT03865992
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer	NCT03141437