Study Summary
This trial is testing a new cancer treatment combining pembrolizumab with carboplatin, to see if it is more effective than carboplatin alone, in treating breast cancer that has spread to the chest wall and is resistant to hormone therapy.
Eligible Conditions
- Breast Cancer
- Chest Wall Syndrome
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Up to 24 weeks
Up to 18 weeks
DCR by immune-related (ir) RECIST
Disease Control Rate (DCR)
Median Progression Free Survival (PFS)
Objective Response Rate (ORR)
Up to 24 weeks
Number of participants with treatment-related adverse events (AEs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Parkinsonism
100%Urinary tract infection
Trial Design
2 Treatment Groups
Arm B: Carboplatin Monotherapy, then Pembrolizumab for participants who progress...
1 of 2
Arm A: Pembrolizumab + Carboplatin
1 of 2
Experimental Treatment
84 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Arm B: Carboplatin Monotherapy, then Pembrolizumab for participants who progress onlyExperimental Group · 3 Interventions: Trastuzumab, Carboplatin, Pembrolizumab · Intervention Types: Biological, Drug, Biological
Arm A: Pembrolizumab + CarboplatinExperimental Group · 3 Interventions: Trastuzumab, Carboplatin, Pembrolizumab · Intervention Types: Biological, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Carboplatin
FDA approved
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks
Who is running the clinical trial?
Johns Hopkins UniversityOTHER
2,092 Previous Clinical Trials
31,769,216 Total Patients Enrolled
25 Trials studying Breast Cancer
23,192 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,706 Previous Clinical Trials
4,963,973 Total Patients Enrolled
53 Trials studying Breast Cancer
7,117 Patients Enrolled for Breast Cancer
Hope Rugo, MDLead Sponsor
4 Previous Clinical Trials
251 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
Mayo ClinicOTHER
2,952 Previous Clinical Trials
3,447,701 Total Patients Enrolled
83 Trials studying Breast Cancer
16,943 Patients Enrolled for Breast Cancer
Translational Breast Cancer Research ConsortiumOTHER
22 Previous Clinical Trials
2,273 Total Patients Enrolled
12 Trials studying Breast Cancer
1,491 Patients Enrolled for Breast Cancer
Massachusetts General HospitalOTHER
2,725 Previous Clinical Trials
31,219,213 Total Patients Enrolled
78 Trials studying Breast Cancer
125,434 Patients Enrolled for Breast Cancer
Neelima VidulaPrincipal InvestigatorMassachusetts General Hospital
Hope Rugo3.713 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
1 Previous Clinical Trials
2,104 Total Patients Enrolled
1 Trials studying Breast Cancer
2,104 Patients Enrolled for Breast Cancer
5Patient Review
Dr. Hope Rugo is simply the best in her field. I've seen her provide expert care to women who were told by other doctors that they only had a short time left. I've seen her work tirelessly to make sure that she sees every patient that was scheduled for that day. I've seen her educate other doctors who were using harmful chemo treatments on the women I brought to her. She is a God-sent and so many lives are depending on her that every second of her time is demanded. If you are annoyed by the long waits or the chaos of the clinic then you are missing the point. The care she provides
Eligibility Criteria
Age 18+ · All Participants · 14 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Cancer that has spread to other parts of the body is allowed.
You don't need to have received radiation therapy on your chest before participating.
You have advanced breast cancer that has spread to your chest wall and cannot be removed with surgery to cure it.
References
- Greenwald, Rebecca J., Gordon J. Freeman, and Arlene H. Sharpe. 2005. “The B7 Family Revisited”. Annual Review of Immunology. Annual Reviews. doi:10.1146/annurev.immunol.23.021704.115611.
- Zhang, Xuewu, Jean-Claude D. Schwartz, Xiaoling Guo, Sumeena Bhatia, Erhu Cao, Lieping Chen, Zhong-Yin Zhang, Michael A. Edidin, Stanley G. Nathenson, and Steven C. Almo. 2004. “Structural and Functional Analysis of the Costimulatory Receptor Programmed Death-1”. Immunity. Elsevier BV. doi:10.1016/s1074-7613(04)00051-2.
- Chemnitz, Jens M., Richard V. Parry, Kim E. Nichols, Carl H. June, and James L. Riley. 2004. “SHP-1 and SHP-2 Associate with Immunoreceptor Tyrosine-based Switch Motif of Programmed Death 1 Upon Primary Human T Cell Stimulation, but Only Receptor Ligation Prevents T Cell Activation”. The Journal of Immunology. The American Association of Immunologists. doi:10.4049/jimmunol.173.2.945.
- Dudley, Mark E., John R. Wunderlich, James C. Yang, Richard M. Sherry, Suzanne L. Topalian, Nicholas P. Restifo, Richard E. Royal, et al.. 2005. “Adoptive Cell Transfer Therapy Following Non-myeloablative but Lymphodepleting Chemotherapy for the Treatment of Patients with Refractory Metastatic Melanoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2005.00.240.
- Sheppard, Kelly-Ann, Lori J. Fitz, Julie M. Lee, Christina Benander, Judith A. George, Joe Wooters, Yongchang Qiu, et al.. 2004. “PD-1 Inhibits T-cell Receptor Induced Phosphorylation of the Zap70/cd3ζ Signalosome and Downstream Signaling to Pkcθ”. FEBS Letters. Wiley. doi:10.1016/j.febslet.2004.07.083.
- Okazaki, Taku, Akito Maeda, Hiroyuki Nishimura, Tomohiro Kurosaki, and Tasuku Honjo. 2001. “PD-1 Immunoreceptor Inhibits B Cell Receptor-mediated Signaling by Recruiting Src Homology 2-domain-containing Tyrosine Phosphatase 2 to Phosphotyrosine”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.231486598.
- Hunder, Naomi N., Herschel Wallen, Jianhong Cao, Deborah W. Hendricks, John Z. Reilly, Rebecca Rodmyre, Achim Jungbluth, Sacha Gnjatic, John A. Thompson, and Cassian Yee. 2008. “Treatment of Metastatic Melanoma with Autologous CD4+ T Cells Against NY-ESO-1”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0800251.
- Riley, James L.. 2009. “PD-1 Signaling in Primary T Cells”. Immunological Reviews. Wiley. doi:10.1111/j.1600-065x.2009.00767.x.
- Disis, Mary L.. 2010. “Immune Regulation of Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2009.27.2146.
- Hunder, Naomi N., Herschel Wallen, Jianhong Cao, Deborah W. Hendricks, John Z. Reilly, Rebecca Rodmyre, Achim Jungbluth, Sacha Gnjatic, John A. Thompson, and Cassian Yee. 2008. “Treatment of Metastatic Melanoma with Autologous CD4+ T Cells Against NY-ESO-1”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0800251.
- Greenwald, Rebecca J., Gordon J. Freeman, and Arlene H. Sharpe. 2005. “The B7 Family Revisited”. Annual Review of Immunology. Annual Reviews. doi:10.1146/annurev.immunol.23.021704.115611.
- Okazaki, Taku, Akito Maeda, Hiroyuki Nishimura, Tomohiro Kurosaki, and Tasuku Honjo. 2001. “PD-1 Immunoreceptor Inhibits B Cell Receptor-mediated Signaling by Recruiting Src Homology 2-domain-containing Tyrosine Phosphatase 2 to Phosphotyrosine”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.231486598.
- Disis, Mary L.. 2010. “Immune Regulation of Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2009.27.2146.
- Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.
- Chemnitz JM, Parry RV, Nichols KE, June CH, Riley JL. SHP-1 and SHP-2 associate with immunoreceptor tyrosine-based switch motif of programmed death 1 upon primary human T cell stimulation, but only receptor ligation prevents T cell activation. J Immunol. 2004 Jul 15;173(2):945-54. doi: 10.4049/jimmunol.173.2.945.
- Sheppard KA, Fitz LJ, Lee JM, Benander C, George JA, Wooters J, Qiu Y, Jussif JM, Carter LL, Wood CR, Chaudhary D. PD-1 inhibits T-cell receptor induced phosphorylation of the ZAP70/CD3zeta signalosome and downstream signaling to PKCtheta. FEBS Lett. 2004 Sep 10;574(1-3):37-41. doi: 10.1016/j.febslet.2004.07.083.
- Zhang X, Schwartz JC, Guo X, Bhatia S, Cao E, Lorenz M, Cammer M, Chen L, Zhang ZY, Edidin MA, Nathenson SG, Almo SC. Structural and functional analysis of the costimulatory receptor programmed death-1. Immunity. 2004 Mar;20(3):337-47. doi: 10.1016/s1074-7613(04)00051-2. Erratum In: Immunity. 2004 May;20(5):651.
- Riley JL. PD-1 signaling in primary T cells. Immunol Rev. 2009 May;229(1):114-25. doi: 10.1111/j.1600-065X.2009.00767.x.
- Dudley ME, Wunderlich JR, Yang JC, Sherry RM, Topalian SL, Restifo NP, Royal RE, Kammula U, White DE, Mavroukakis SA, Rogers LJ, Gracia GJ, Jones SA, Mangiameli DP, Pelletier MM, Gea-Banacloche J, Robinson MR, Berman DM, Filie AC, Abati A, Rosenberg SA. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005 Apr 1;23(10):2346-57. doi: 10.1200/JCO.2005.00.240.
- Okazaki T, Maeda A, Nishimura H, Kurosaki T, Honjo T. PD-1 immunoreceptor inhibits B cell receptor-mediated signaling by recruiting src homology 2-domain-containing tyrosine phosphatase 2 to phosphotyrosine. Proc Natl Acad Sci U S A. 2001 Nov 20;98(24):13866-71. doi: 10.1073/pnas.231486598. Epub 2001 Nov 6.
- Hope Rugo, MD 2017. "Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03095352.
Frequently Asked Questions
What illnesses has Pembrolizumab been demonstrated to alleviate?
"Pembrolizumab is often utilized to manage refractory and relapsed mediastinal large b-cell lymphoma. Additionally, it may be beneficial in the initial treatment of inflammatory breast cancer (IBC) and advanced testicular cancer." - Anonymous Online Contributor
Unverified Answer
Does this research still have space for participants to join?
"Precisely. Clinicaltrials.gov attests that this clinical investigation, which was originally posted on September 2nd 2017, is actively enrolling individuals in need of medical care. 84 participants must be recruited from 7 distinct sites around the country." - Anonymous Online Contributor
Unverified Answer
What is the total number of participants in this medical research project?
"Affirmative, the trial is actively recruiting based on information sourced from clinicaltrials.gov. It was initiated on September 2nd 2017 and last updated on August 8th 2022, with 84 patients needed to be enrolled across 7 sites." - Anonymous Online Contributor
Unverified Answer
Are there any other studies which have utilized Pembrolizumab as a therapeutic agent?
"Currently, 1707 clinical trials featuring Pembrolizumab are being conducted. Out of those, 348 have entered Phase 3 testing. Seattle is one location where this treatment has been studied; however, there exist 83632 other sites hosting investigations into pembrozilium's efficacy." - Anonymous Online Contributor
Unverified Answer
To what extent could Pembrolizumab potentially be hazardous to people?
"The safety of Pembrolizumab was rated a 2 on the Power scale due to Phase 2 status, meaning that while there is information suggesting it is safe for use, efficacy has not yet been determined." - Anonymous Online Contributor
Unverified Answer
Could you enumerate the number of medical facilities administering this research study in the state?
"This research endeavour is running at 7 sites, which are located in cities like San Francisco, Indianapolis and Pittsburgh among a few other areas. To ensure minimal travel burden to the participant, it's important to choose the closest medical facility for enrollment." - Anonymous Online Contributor
Unverified Answer