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1. Ganitumab and metformin plus standard neoadjuvant therapy in stage 2/3 breast cancer.

Author

Yee, Douglas, Isaacs, Claudine, Wolf, Denise M, Yau, Christina, Haluska, Paul, Giridhar, Karthik V, Forero-Torres, Andres, Jo Chien, A, Wallace, Anne M, Pusztai, Lajos, Albain, Kathy S, Ellis, Erin D, Beckwith, Heather, Haley, Barbara B, Elias, Anthony D, Boughey, Judy C, Kemmer, Kathleen, Yung, Rachel L, Pohlmann, Paula R, Tripathy, Debu, Clark, Amy S, Han, Hyo S, Nanda, Rita, Khan, Qamar J, Edmiston, Kristen K, Petricoin, Emanuel F, Stringer-Reasor, Erica, Falkson, Carla I, Majure, Melanie, Mukhtar, Rita A, Helsten, Teresa L, Moulder, Stacy L, Robinson, Patricia A, Wulfkuhle, Julia D, Brown-Swigart, Lamorna, Buxton, Meredith, Clennell, Julia L, Paoloni, Melissa, Sanil, Ashish, Berry, Scott, Asare, Smita M, Wilson, Amy, Hirst, Gillian L, Singhrao, Ruby, Asare, Adam L, Matthews, Jeffrey B, Hylton, Nola M, DeMichele, Angela, Melisko, Michelle, Perlmutter, Jane, Rugo, Hope S, Fraser Symmans, W, Van't Veer, Laura J, Berry, Donald A, and Esserman, Laura J

Subjects
Diabetes, Cancer, Breast Cancer, 6.1 Pharmaceuticals
Abstract

I-SPY2 is an adaptively randomized phase 2 clinical trial evaluating novel agents in combination with standard-of-care paclitaxel followed by doxorubicin and cyclophosphamide in the neoadjuvant treatment of breast cancer. Ganitumab is a monoclonal antibody designed to bind and inhibit function of the type I insulin-like growth factor receptor (IGF-1R). Ganitumab was tested in combination with metformin and paclitaxel (PGM) followed by AC compared to standard-of-care alone. While pathologic complete response (pCR) rates were numerically higher in the PGM treatment arm for hormone receptor-negative, HER2-negative breast cancer (32% versus 21%), this small increase did not meet I-SPY's prespecified threshold for graduation. PGM was associated with increased hyperglycemia and elevated hemoglobin A1c (HbA1c), despite the use of metformin in combination with ganitumab. We evaluated several putative predictive biomarkers of ganitumab response (e.g., IGF-1 ligand score, IGF-1R signature, IGFBP5 expression, baseline HbA1c). None were specific predictors of response to PGM, although several signatures were associated with pCR in both arms. Any further development of anti-IGF-1R therapy will require better control of anti-IGF-1R drug-induced hyperglycemia and the development of more predictive biomarkers.

Published
2021

2. Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE)

Author

Talhouk, Aline, George, Joshy, Wang, Chen, Budden, Timothy, Tan, Tuan Zea, Chiu, Derek S, Kommoss, Stefan, San Leong, Huei, Chen, Stephanie, Intermaggio, Maria P, Gilks, Blake, Nazeran, Tayyebeh M, Volchek, Mila, Elatre, Wafaa, Bentley, Rex C, Senz, Janine, Lum, Amy, Chow, Veronica, Sudderuddin, Hanwei, Mackenzie, Robertson, Leong, Samuel CY, Liu, Geyi, Johnson, Dustin, Chen, Billy, Group, AOCS, Alsop, Jennifer, Banerjee, Susana N, Behrens, Sabine, Bodelon, Clara, Brand, Alison H, Brinton, Louise, Carney, Michael E, Chiew, Yoke-Eng, Cushing-Haugen, Kara L, Cybulski, Cezary, Ennis, Darren, Fereday, Sian, Fortner, Renée T, García-Donas, Jesús, Gentry-Maharaj, Aleksandra, Glasspool, Rosalind, Goranova, Teodora, Greene, Casey S, Haluska, Paul, Harris, Holly R, Hendley, Joy, Hernandez, Brenda Y, Herpel, Esther, Jimenez-Linan, Mercedes, Karpinskyj, Chloe, Kaufmann, Scott H, Keeney, Gary L, Kennedy, Catherine J, Köbel, Martin, Koziak, Jennifer M, Larson, Melissa C, Lester, Jenny, Lewsley, Liz-Anne, Lissowska, Jolanta, Lubiński, Jan, Luk, Hugh, Macintyre, Geoff, Mahner, Sven, McNeish, Iain A, Menkiszak, Janusz, Nevins, Nikilyn, Osorio, Ana, Oszurek, Oleg, Palacios, José, Hinsley, Samantha, Pearce, Celeste L, Pike, Malcolm C, Piskorz, Anna M, Ray-Coquard, Isabelle, Rhenius, Valerie, Rodriguez-Antona, Cristina, Sharma, Raghwa, Sherman, Mark E, De Silva, Dilrini, Singh, Naveena, Sinn, Peter, Slamon, Dennis, Song, Honglin, Steed, Helen, Stronach, Euan A, Thompson, Pamela J, Tołoczko, Aleksandra, Trabert, Britton, Traficante, Nadia, Tseng, Chiu-Chen, Widschwendter, Martin, Wilkens, Lynne R, Winham, Stacey J, Winterhoff, Boris, Beeghly-Fadiel, Alicia, Benitez, Javier, Berchuck, Andrew, Brenton, James D, Brown, Robert, and Chang-Claude, Jenny

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer Genomics, Orphan Drug, Genetics, Precision Medicine, Rare Diseases, Human Genome, Women's Health, Ovarian Cancer, Cancer, 4.2 Evaluation of markers and technologies, Good Health and Well Being, Aged, Algorithms, Cystadenoma, Serous, Female, Gene Expression Regulation, Neoplastic, Humans, Lymphocytes, Tumor-Infiltrating, Middle Aged, Neoplasm Grading, Neoplasm Proteins, Neoplasm, Residual, Ovarian Neoplasms, Transcriptome, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeGene expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by nonstandardized methods, which are not applicable in a clinical setting. We sought to generate a clinical grade minimal gene set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.Experimental designAdopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene expression data from 1,650 tumors. We applied resulting models to NanoString data on 3,829 HGSOCs from the Ovarian Tumor Tissue Analysis consortium. We further developed, confirmed, and validated a reduced, minimal gene set predictor, with methods suitable for a single-patient setting.ResultsGene expression data were used to derive the predictor of high-grade serous ovarian carcinoma molecular subtype (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor-infiltrating lymphocytes, and outcome. The locked-down clinical grade PrOTYPE test includes a model with 55 genes that predicted gene expression subtype with >95% accuracy that was maintained in all analytic and biological validations.ConclusionsWe validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.See related commentary by McMullen et al., p. 5271.

Published
2020

4. Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance)

Author

Haddad, Tufia C., He, Jun, O’Sullivan, Ciara C., Chen, Beiyun, Northfelt, Donald, Dueck, Amylou C., Ballman, Karla V., Tenner, Kathleen S., Linden, Hannah, Sparano, Joseph A., Hopkins, Judith O., De Silva, Chamath, Perez, Edith A., Haluska, Paul, and Goetz, Matthew P.

Published
2021
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5. Phase 1 trial of Vismodegib and Erlotinib combination in metastatic pancreatic cancer

Author

McCleary-Wheeler, Angela L., Carr, Ryan M., Palmer, Shanique R., Smyrk, Thomas C., Allred, Jacob B., Almada, Luciana L., Tolosa, Ezequiel J., Lamberti, Maria J., Marks, David L., Borad, Mitesh J., Molina, Julian R., Qi, Yingwei, Lingle, Wilma L., Grothey, Axel, Pitot, Henry C., Jatoi, Aminah, Northfelt, Donald W., Bryce, Alan H., McWilliams, Robert R., Okuno, Scott H., Haluska, Paul, Kim, George P., Colon-Otero, Gerardo, Lowe, Val J., Callstrom, Matthew R., Ma, Wen We, Bekaii-Saab, Tanios, Hung, Mien-Chie, Erlichman, Charles, and Fernandez-Zapico, Martin E.

Published
2020
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6. The Neoadjuvant Model Is Still the Future for Drug Development in Breast Cancer.

Author

DeMichele, Angela, Yee, Douglas, Berry, Donald A, Albain, Kathy S, Benz, Christopher C, Boughey, Judy, Buxton, Meredith, Chia, Stephen K, Chien, Amy J, Chui, Stephen Y, Clark, Amy, Edmiston, Kirsten, Elias, Anthony D, Forero-Torres, Andres, Haddad, Tufia C, Haley, Barbara, Haluska, Paul, Hylton, Nola M, Isaacs, Claudine, Kaplan, Henry, Korde, Larissa, Leyland-Jones, Brian, Liu, Minetta C, Melisko, Michelle, Minton, Susan E, Moulder, Stacy L, Nanda, Rita, Olopade, Olufunmilayo I, Paoloni, Melissa, Park, John W, Parker, Barbara A, Perlmutter, Jane, Petricoin, Emanuel F, Rugo, Hope, Symmans, Fraser, Tripathy, Debasish, van't Veer, Laura J, Viscusi, Rebecca K, Wallace, Anne, Wolf, Denise, Yau, Christina, and Esserman, Laura J

Subjects
Humans, Breast Neoplasms, Treatment Outcome, Chemotherapy, Adjuvant, Neoadjuvant Therapy, Female, Clinical Trials as Topic, Drug Discovery, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

The many improvements in breast cancer therapy in recent years have so lowered rates of recurrence that it is now difficult or impossible to conduct adequately powered adjuvant clinical trials. Given the many new drugs and potential synergistic combinations, the neoadjuvant approach has been used to test benefit of drug combinations in clinical trials of primary breast cancer. A recent FDA-led meta-analysis showed that pathologic complete response (pCR) predicts disease-free survival (DFS) within patients who have specific breast cancer subtypes. This meta-analysis motivated the FDA's draft guidance for using pCR as a surrogate endpoint in accelerated drug approval. Using pCR as a registration endpoint was challenged at ASCO 2014 Annual Meeting with the presentation of ALTTO, an adjuvant trial in HER2-positive breast cancer that showed a nonsignificant reduction in DFS hazard rate for adding lapatinib, a HER-family tyrosine kinase inhibitor, to trastuzumab and chemotherapy. This conclusion seemed to be inconsistent with the results of NeoALTTO, a neoadjuvant trial that found a statistical improvement in pCR rate for the identical lapatinib-containing regimen. We address differences in the two trials that may account for discordant conclusions. However, we use the FDA meta-analysis to show that there is no discordance at all between the observed pCR difference in NeoALTTO and the observed HR in ALTTO. This underscores the importance of appropriately modeling the two endpoints when designing clinical trials. The I-SPY 2/3 neoadjuvant trials exemplify this approach.

Published
2015

7. TBCRC 019: A Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel with or without the Anti-Death Receptor 5 Monoclonal Antibody Tigatuzumab in Patients with Triple-Negative Breast Cancer

Author

Forero-Torres, Andres, Consortium, on behalf of the Translational Breast Cancer Research, Varley, Katherine E, Abramson, Vandana G, Li, Yufeng, Vaklavas, Christos, Lin, Nancy U, Liu, Minetta C, Rugo, Hope S, Nanda, Rita, Storniolo, Anna M, Traina, Tiffany A, Patil, Sujata, Van Poznak, Catherine H, Nangia, Julie R, Irvin, William J, Krontiras, Helen, De Los Santos, Jennifer F, Haluska, Paul, Grizzle, William, Myers, Richard M, and Wolff, Antonio C

Subjects
Clinical Research, Cancer, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Biopsy, Female, Humans, Middle Aged, Nanoparticles, Paclitaxel, Receptors, TNF-Related Apoptosis-Inducing Ligand, Retreatment, Treatment Outcome, Triple Negative Breast Neoplasms, Translational Breast Cancer Research Consortium, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeTigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5(+) human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).Experimental designRandomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required.ResultsAmong 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm.ConclusionsORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation.

Published
2015

9. Tumorgrafts as In Vivo Surrogates for Women with Ovarian Cancer

Author

Weroha, S John, Becker, Marc A, Enderica-Gonzalez, Sergio, Harrington, Sean C, Oberg, Ann L, Maurer, Matthew J, Perkins, Sarah E, AlHilli, Mariam, Butler, Kristina A, McKinstry, Sarah, Fink, Stephanie, Jenkins, Robert B, Hou, Xiaonan, Kalli, Kimberly R, Goodman, Karin M, Sarkaria, Jann N, Karlan, Beth Y, Kumar, Amanika, Kaufmann, Scott H, Hartmann, Lynn C, and Haluska, Paul

Subjects
Rare Diseases, Ovarian Cancer, Orphan Drug, Cancer, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Animals, Biomarkers, Tumor, Chromosome Aberrations, Cluster Analysis, Comparative Genomic Hybridization, Disease Models, Animal, Female, Gene Expression Profiling, Gene Expression Regulation, Neoplastic, Graft Survival, Heterografts, Humans, Mice, Middle Aged, Neoplasm Grading, Neoplasm Metastasis, Neoplasm Staging, Ovarian Neoplasms, Ultrasonography, Xenograft Model Antitumor Assays, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeOvarian cancer has a high recurrence and mortality rate. A barrier to improved outcomes includes a lack of accurate models for preclinical testing of novel therapeutics.Experimental designClinically relevant, patient-derived tumorgraft models were generated from sequential patients and the first 168 engrafted models are described. Fresh ovarian, primary peritoneal, and fallopian tube carcinomas were collected at the time of debulking surgery and injected intraperitoneally into severe combined immunodeficient mice.ResultsTumorgrafts demonstrated a 74% engraftment rate with microscopic fidelity of primary tumor characteristics. Low-passage tumorgrafts also showed comparable genomic aberrations with the corresponding primary tumor and exhibit gene set enrichment of multiple ovarian cancer molecular subtypes, similar to patient tumors. Importantly, each of these tumorgraft models is annotated with clinical data and for those that have been tested, response to platinum chemotherapy correlates with the source patient.ConclusionsPresented herein is the largest known living tumor bank of patient-derived, ovarian tumorgraft models that can be applied to the development of personalized cancer treatment.

Published
2014

10. Developing Safety Criteria for Introducing New Agents into Neoadjuvant Trials

Author

DeMichele, Angela, Berry, Donald A, Zujewski, JoAnne, Hunsberger, Sally, Rubinstein, Larry, Tomaszewski, Joseph E, Kelloff, Gary, Perlmutter, Jane, Buxton, Meredith, Lyandres, Julia, Albain, Kathy S, Benz, Chris, Chien, A Jo, Haluska, Paul, Leyland-Jones, Brian, Liu, Minetta C, Munster, Pamela, Olopade, Olufunmilayo, Park, John W, Parker, Barbara A, Pusztai, Lajos, Tripathy, Debu, Rugo, Hope, Yee, Douglas, and Esserman, Laura

Subjects
Cancer, Patient Safety, Clinical Trials and Supportive Activities, Rare Diseases, Orphan Drug, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Pharmacological, Clinical Trials as Topic, Drug Interactions, Humans, Neoadjuvant Therapy, Research Design, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

New approaches to drug development are critically needed to lessen the time, cost, and resources necessary to identify and optimize active agents. Strategies to accelerate drug development include testing drugs earlier in the disease process, such as the neoadjuvant setting. The U.S. Food and Drug Administration (FDA) has issued guidance designed to accelerate drug approval through the use of neoadjuvant studies in which the surrogate short-term endpoint, pathologic response, can be used to identify active agents and shorten the time to approval of both efficacious drugs and biomarkers identifying patients most likely to respond. However, this approach has unique challenges. In particular, issues of patient safety are paramount, given the exposure of potentially curable patients to investigational agents with limited safety experience. Key components to safe drug development in the neoadjuvant setting include defining a study population at sufficiently poor prognosis with standard therapy to justify exposure to investigational agents, defining the extent and adequacy of safety data from phase I, detecting potentially harmful interactions between investigational and standard therapies, improving study designs, such as adaptive strategies, that limit patient exposure to ineffective agents, and intensifying safety monitoring in the course of the trial. The I-SPY2 trial is an example of a phase II neoadjuvant trial of novel agents for breast cancer in which these issues have been addressed, both in the design and conduct of the trial. These adaptations of phase II design enable acceleration of drug development by reducing time and cost to screen novel therapies for activity without compromising safety.

Published
2013

13. In vivo anti-tumor activity of the PARP inhibitor niraparib in homologous recombination deficient and proficient ovarian carcinoma

Author

AlHilli, Mariam M., Becker, Marc A., Weroha, S. John, Flatten, Karen S., Hurley, Rachel M., Harrell, Maria I., Oberg, Ann L., Maurer, Matt J., Hawthorne, Kieran M., Hou, Xiaonan, Harrington, Sean C., McKinstry, Sarah, Meng, X. Wei, Wilcoxen, Keith M., Kalli, Kimberly R., Swisher, Elizabeth M., Kaufmann, Scott H., and Haluska, Paul

Published
2016
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20. Supplementary Figure Legend from Tumorgrafts as In Vivo Surrogates for Women with Ovarian Cancer

Author

Weroha, S. John, primary, Becker, Marc A., primary, Enderica-Gonzalez, Sergio, primary, Harrington, Sean C., primary, Oberg, Ann L., primary, Maurer, Matthew J., primary, Perkins, Sarah E., primary, AlHilli, Mariam, primary, Butler, Kristina A., primary, McKinstry, Sarah, primary, Fink, Stephanie, primary, Jenkins, Robert B., primary, Hou, Xiaonan, primary, Kalli, Kimberly R., primary, Goodman, Karin M., primary, Sarkaria, Jann N., primary, Karlan, Beth Y., primary, Kumar, Amanika, primary, Kaufmann, Scott H., primary, Hartmann, Lynn C., primary, and Haluska, Paul, primary

Published
2023
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21. Supplementary File 1 from Active Estrogen Receptor-alpha Signaling in Ovarian Cancer Models and Clinical Specimens

Author

Andersen, Courtney L., primary, Sikora, Matthew J., primary, Boisen, Michelle M., primary, Ma, Tianzhou, primary, Christie, Alec, primary, Tseng, George, primary, Park, Yongseok, primary, Luthra, Soumya, primary, Chandran, Uma, primary, Haluska, Paul, primary, Mantia-Smaldone, Gina M., primary, Odunsi, Kunle, primary, McLean, Karen, primary, Lee, Adrian V., primary, Elishaev, Esther, primary, Edwards, Robert P., primary, and Oesterreich, Steffi, primary

Published
2023
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22. Data from Drug Efflux by Breast Cancer Resistance Protein Is a Mechanism of Resistance to the Benzimidazole Insulin-Like Growth Factor Receptor/Insulin Receptor Inhibitor, BMS-536924

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Carboni, Joan M., primary, Flatten, Karen, primary, Asmann, Yan W., primary, Ten Eyck, Cynthia, primary, Nakanishi, Takeo, primary, Tibodeau, Jennifer D., primary, Ross, Douglas D., primary, Gottardis, Marco M., primary, Erlichman, Charles, primary, Kaufmann, Scott H., primary, and Haluska, Paul, primary

Published
2023
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23. Supplemental Materials, Supplementary Tables 1-3 from A First-in-Human Phase I Study of the Oral p38 MAPK Inhibitor, Ralimetinib (LY2228820 Dimesylate), in Patients with Advanced Cancer

Author

Patnaik, Amita, primary, Haluska, Paul, primary, Tolcher, Anthony W., primary, Erlichman, Charles, primary, Papadopoulos, Kyriakos P., primary, Lensing, Janet L., primary, Beeram, Muralidhar, primary, Molina, Julian R., primary, Rasco, Drew W., primary, Arcos, Rebecca R., primary, Kelly, Claudia S., primary, Wijayawardana, Sameera R., primary, Zhang, Xuekui, primary, Stancato, Louis F., primary, Bell, Robert, primary, Shi, Peipei, primary, Kulanthaivel, Palaniappan, primary, Pitou, Celine, primary, Mulle, Lynette B., primary, Farrington, Daphne L., primary, Chan, Edward M., primary, and Goetz, Matthew P., primary

Published
2023
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24. Supplementary Table S1 from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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25. Supplementary Figures from Active Estrogen Receptor-alpha Signaling in Ovarian Cancer Models and Clinical Specimens

Author

Andersen, Courtney L., primary, Sikora, Matthew J., primary, Boisen, Michelle M., primary, Ma, Tianzhou, primary, Christie, Alec, primary, Tseng, George, primary, Park, Yongseok, primary, Luthra, Soumya, primary, Chandran, Uma, primary, Haluska, Paul, primary, Mantia-Smaldone, Gina M., primary, Odunsi, Kunle, primary, McLean, Karen, primary, Lee, Adrian V., primary, Elishaev, Esther, primary, Edwards, Robert P., primary, and Oesterreich, Steffi, primary

Published
2023
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26. Supplementary Figure 3 from Drug Efflux by Breast Cancer Resistance Protein Is a Mechanism of Resistance to the Benzimidazole Insulin-Like Growth Factor Receptor/Insulin Receptor Inhibitor, BMS-536924

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Carboni, Joan M., primary, Flatten, Karen, primary, Asmann, Yan W., primary, Ten Eyck, Cynthia, primary, Nakanishi, Takeo, primary, Tibodeau, Jennifer D., primary, Ross, Douglas D., primary, Gottardis, Marco M., primary, Erlichman, Charles, primary, Kaufmann, Scott H., primary, and Haluska, Paul, primary

Published
2023
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27. Supplementary Figure Legends from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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28. Supplementary Data from A Phase I Clinical Trial of the Poly(ADP-ribose) Polymerase Inhibitor Veliparib and Weekly Topotecan in Patients with Solid Tumors

Author

Wahner Hendrickson, Andrea E., primary, Menefee, Michael E., primary, Hartmann, Lynn C., primary, Long, Harry J., primary, Northfelt, Donald W., primary, Reid, Joel M., primary, Boakye-Agyeman, Felix, primary, Kayode, Olumide, primary, Flatten, Karen S., primary, Harrell, Maria I., primary, Swisher, Elizabeth M., primary, Poirier, Guy G., primary, Satele, Daniel, primary, Allred, Jake, primary, Lensing, Janet L., primary, Chen, Alice, primary, Ji, Jiuping, primary, Zang, Yiping, primary, Erlichman, Charles, primary, Haluska, Paul, primary, and Kaufmann, Scott H., primary

Published
2023
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29. Supplementary Figure Legends from Drug Efflux by Breast Cancer Resistance Protein Is a Mechanism of Resistance to the Benzimidazole Insulin-Like Growth Factor Receptor/Insulin Receptor Inhibitor, BMS-536924

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Carboni, Joan M., primary, Flatten, Karen, primary, Asmann, Yan W., primary, Ten Eyck, Cynthia, primary, Nakanishi, Takeo, primary, Tibodeau, Jennifer D., primary, Ross, Douglas D., primary, Gottardis, Marco M., primary, Erlichman, Charles, primary, Kaufmann, Scott H., primary, and Haluska, Paul, primary

Published
2023
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30. Supplementary Figures 1 - 4 from Tumorgrafts as In Vivo Surrogates for Women with Ovarian Cancer

Author

Weroha, S. John, primary, Becker, Marc A., primary, Enderica-Gonzalez, Sergio, primary, Harrington, Sean C., primary, Oberg, Ann L., primary, Maurer, Matthew J., primary, Perkins, Sarah E., primary, AlHilli, Mariam, primary, Butler, Kristina A., primary, McKinstry, Sarah, primary, Fink, Stephanie, primary, Jenkins, Robert B., primary, Hou, Xiaonan, primary, Kalli, Kimberly R., primary, Goodman, Karin M., primary, Sarkaria, Jann N., primary, Karlan, Beth Y., primary, Kumar, Amanika, primary, Kaufmann, Scott H., primary, Hartmann, Lynn C., primary, and Haluska, Paul, primary

Published
2023
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31. Supplementary Figure 1 from Drug Efflux by Breast Cancer Resistance Protein Is a Mechanism of Resistance to the Benzimidazole Insulin-Like Growth Factor Receptor/Insulin Receptor Inhibitor, BMS-536924

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Carboni, Joan M., primary, Flatten, Karen, primary, Asmann, Yan W., primary, Ten Eyck, Cynthia, primary, Nakanishi, Takeo, primary, Tibodeau, Jennifer D., primary, Ross, Douglas D., primary, Gottardis, Marco M., primary, Erlichman, Charles, primary, Kaufmann, Scott H., primary, and Haluska, Paul, primary

Published
2023
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32. Supplementary Figure 2A from Drug Efflux by Breast Cancer Resistance Protein Is a Mechanism of Resistance to the Benzimidazole Insulin-Like Growth Factor Receptor/Insulin Receptor Inhibitor, BMS-536924

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Carboni, Joan M., primary, Flatten, Karen, primary, Asmann, Yan W., primary, Ten Eyck, Cynthia, primary, Nakanishi, Takeo, primary, Tibodeau, Jennifer D., primary, Ross, Douglas D., primary, Gottardis, Marco M., primary, Erlichman, Charles, primary, Kaufmann, Scott H., primary, and Haluska, Paul, primary

Published
2023
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33. Supplementary File 2 from Active Estrogen Receptor-alpha Signaling in Ovarian Cancer Models and Clinical Specimens

Author

Andersen, Courtney L., primary, Sikora, Matthew J., primary, Boisen, Michelle M., primary, Ma, Tianzhou, primary, Christie, Alec, primary, Tseng, George, primary, Park, Yongseok, primary, Luthra, Soumya, primary, Chandran, Uma, primary, Haluska, Paul, primary, Mantia-Smaldone, Gina M., primary, Odunsi, Kunle, primary, McLean, Karen, primary, Lee, Adrian V., primary, Elishaev, Esther, primary, Edwards, Robert P., primary, and Oesterreich, Steffi, primary

Published
2023
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34. Supplementary File 3 from Active Estrogen Receptor-alpha Signaling in Ovarian Cancer Models and Clinical Specimens

Author

Andersen, Courtney L., primary, Sikora, Matthew J., primary, Boisen, Michelle M., primary, Ma, Tianzhou, primary, Christie, Alec, primary, Tseng, George, primary, Park, Yongseok, primary, Luthra, Soumya, primary, Chandran, Uma, primary, Haluska, Paul, primary, Mantia-Smaldone, Gina M., primary, Odunsi, Kunle, primary, McLean, Karen, primary, Lee, Adrian V., primary, Elishaev, Esther, primary, Edwards, Robert P., primary, and Oesterreich, Steffi, primary

Published
2023
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35. Supplemental Figure 1 from TBCRC 019: A Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel with or without the Anti-Death Receptor 5 Monoclonal Antibody Tigatuzumab in Patients with Triple-Negative Breast Cancer

Author

Forero-Torres, Andres, primary, Varley, Katherine E., primary, Abramson, Vandana G., primary, Li, Yufeng, primary, Vaklavas, Christos, primary, Lin, Nancy U., primary, Liu, Minetta C., primary, Rugo, Hope S., primary, Nanda, Rita, primary, Storniolo, Anna M., primary, Traina, Tiffany A., primary, Patil, Sujata, primary, Van Poznak, Catherine H., primary, Nangia, Julie R., primary, Irvin, William J., primary, Krontiras, Helen, primary, De Los Santos, Jennifer F., primary, Haluska, Paul, primary, Grizzle, William, primary, Myers, Richard M., primary, and Wolff, Antonio C., primary

Published
2023
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37. Supplemental Figure S1 from A First-in-Human Phase I Study of the Oral p38 MAPK Inhibitor, Ralimetinib (LY2228820 Dimesylate), in Patients with Advanced Cancer

Author

Patnaik, Amita, primary, Haluska, Paul, primary, Tolcher, Anthony W., primary, Erlichman, Charles, primary, Papadopoulos, Kyriakos P., primary, Lensing, Janet L., primary, Beeram, Muralidhar, primary, Molina, Julian R., primary, Rasco, Drew W., primary, Arcos, Rebecca R., primary, Kelly, Claudia S., primary, Wijayawardana, Sameera R., primary, Zhang, Xuekui, primary, Stancato, Louis F., primary, Bell, Robert, primary, Shi, Peipei, primary, Kulanthaivel, Palaniappan, primary, Pitou, Celine, primary, Mulle, Lynette B., primary, Farrington, Daphne L., primary, Chan, Edward M., primary, and Goetz, Matthew P., primary

Published
2023
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38. Supplementary Figure S2 from Clinical and Translational Results of a Phase II, Randomized Trial of an Anti–IGF-1R (Cixutumumab) in Women with Breast Cancer That Progressed on Endocrine Therapy

Author

Gradishar, William J., primary, Yardley, Denise A., primary, Layman, Rachel, primary, Sparano, Joseph A., primary, Chuang, Ellen, primary, Northfelt, Donald W., primary, Schwartz, Gary N., primary, Youssoufian, Hagop, primary, Tang, Shande, primary, Novosiadly, Ruslan, primary, Forest, Amelie, primary, Nguyen, Tuan S., primary, Cosaert, Jan, primary, Grebennik, Dmitri, primary, and Haluska, Paul, primary

Published
2023
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41. Supplementary Figure 5 from Immune-Induced Epithelial to Mesenchymal Transition In vivo Generates Breast Cancer Stem Cells

Author

Santisteban, Marta, primary, Reiman, Jennifer M., primary, Asiedu, Michael K., primary, Behrens, Marshall D., primary, Nassar, Aziza, primary, Kalli, Kimberly R., primary, Haluska, Paul, primary, Ingle, James N., primary, Hartmann, Lynn C., primary, Manjili, Masoud H., primary, Radisky, Derek C., primary, Ferrone, Soldano, primary, and Knutson, Keith L., primary

Published
2023
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42. Supplementary Figure 3 from Immune-Induced Epithelial to Mesenchymal Transition In vivo Generates Breast Cancer Stem Cells

Author

Santisteban, Marta, primary, Reiman, Jennifer M., primary, Asiedu, Michael K., primary, Behrens, Marshall D., primary, Nassar, Aziza, primary, Kalli, Kimberly R., primary, Haluska, Paul, primary, Ingle, James N., primary, Hartmann, Lynn C., primary, Manjili, Masoud H., primary, Radisky, Derek C., primary, Ferrone, Soldano, primary, and Knutson, Keith L., primary

Published
2023
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44. Data from Expression of Insulin Receptor Isoform A and Insulin-like Growth Factor-1 Receptor in Human Acute Myelogenous Leukemia: Effect of the Dual-Receptor Inhibitor BMS-536924 In vitro

Author

Wahner Hendrickson, Andrea E., primary, Haluska, Paul, primary, Schneider, Paula A., primary, Loegering, David A., primary, Peterson, Kevin L., primary, Attar, Ricardo, primary, Smith, B. Douglas, primary, Erlichman, Charles, primary, Gottardis, Marco, primary, Karp, Judith E., primary, Carboni, Joan M., primary, and Kaufmann, Scott H., primary

Published
2023
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45. Data from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Author

Galanis, Evanthia, primary, Hartmann, Lynn C., primary, Cliby, William A., primary, Long, Harry J., primary, Peethambaram, Prema P., primary, Barrette, Brigitte A., primary, Kaur, Judith S., primary, Haluska, Paul J., primary, Aderca, Ileana, primary, Zollman, Paula J., primary, Sloan, Jeff A., primary, Keeney, Gary, primary, Atherton, Pamela J., primary, Podratz, Karl C., primary, Dowdy, Sean C., primary, Stanhope, C. Robert, primary, Wilson, Timothy O., primary, Federspiel, Mark J., primary, Peng, Kah-Whye, primary, and Russell, Stephen J., primary

Published
2023
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46. Data from Immune-Induced Epithelial to Mesenchymal Transition In vivo Generates Breast Cancer Stem Cells

Author

Santisteban, Marta, primary, Reiman, Jennifer M., primary, Asiedu, Michael K., primary, Behrens, Marshall D., primary, Nassar, Aziza, primary, Kalli, Kimberly R., primary, Haluska, Paul, primary, Ingle, James N., primary, Hartmann, Lynn C., primary, Manjili, Masoud H., primary, Radisky, Derek C., primary, Ferrone, Soldano, primary, and Knutson, Keith L., primary

Published
2023
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48. Supplementary Figure 2 from Immune-Induced Epithelial to Mesenchymal Transition In vivo Generates Breast Cancer Stem Cells

Author

Santisteban, Marta, primary, Reiman, Jennifer M., primary, Asiedu, Michael K., primary, Behrens, Marshall D., primary, Nassar, Aziza, primary, Kalli, Kimberly R., primary, Haluska, Paul, primary, Ingle, James N., primary, Hartmann, Lynn C., primary, Manjili, Masoud H., primary, Radisky, Derek C., primary, Ferrone, Soldano, primary, and Knutson, Keith L., primary

Published
2023
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49. Supplementary Figure 2 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Author

Galanis, Evanthia, primary, Hartmann, Lynn C., primary, Cliby, William A., primary, Long, Harry J., primary, Peethambaram, Prema P., primary, Barrette, Brigitte A., primary, Kaur, Judith S., primary, Haluska, Paul J., primary, Aderca, Ileana, primary, Zollman, Paula J., primary, Sloan, Jeff A., primary, Keeney, Gary, primary, Atherton, Pamela J., primary, Podratz, Karl C., primary, Dowdy, Sean C., primary, Stanhope, C. Robert, primary, Wilson, Timothy O., primary, Federspiel, Mark J., primary, Peng, Kah-Whye, primary, and Russell, Stephen J., primary

Published
2023
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50. Supplementary Figure 3 from Dual IGF-1R/InsR Inhibitor BMS-754807 Synergizes with Hormonal Agents in Treatment of Estrogen-Dependent Breast Cancer

Author

Hou, Xiaonan, primary, Huang, Fei, primary, Macedo, Luciana F., primary, Harrington, Sean C., primary, Reeves, Karen A., primary, Greer, Ann, primary, Finckenstein, Friedrich Graf, primary, Brodie, Angela, primary, Gottardis, Marco M., primary, Carboni, Joan M., primary, and Haluska, Paul, primary

Published
2023
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