BOSTON (PRWEB)
August 11, 2021

CISCRP (Center for Information and Study on Clinical Research Participation) and Oxford PharmaGenesis worked together with Daiichi Sankyo, AstraZeneca and Dr. Shanu Modi of Memorial Sloan Kettering Cancer Center in New York to write a plain language summary publication (PLSP) of the results of the DESTINY-Breast01 clinical study. The participants in the study received a treatment called trastuzumab deruxtecan, also known as T-DXd. T-DXd consists of a chemotherapy drug linked to a manmade antibody. The antibody in T-DXd is a protein that specifically targets and attaches to the HER2 protein on tumor cells. The PLSP was recently published in Future Oncology with the title “Trastuzumab Deruxtecan in Previously Treated HER2-Positive Metastatic Breast Cancer: Plain Language Summary of the DESTINY-Breast01 Study”. View the article here: https://www.futuremedicine.com/doi/pdf/10.2217/fon-2021-0427

Public, patient, and health care community demand for plain language information on results of clinical trials is extremely high. For more than ten years, CISCRP — a non-profit organization — has been translating scientific clinical trial results information into plain, non-technical language for patients and the public around the world to be communicated in print and digital formats.

The teams involved—Daiichi Sankyo, AstraZeneca, CISCRP, Oxford PharmaGenesis, and Dr. Modi —worked to ensure the PLSP was easy-to-read by adding creative visuals, tables and key questions answered about the DESTINY-Breast01 trial. The PLSP was reviewed by an editorial panel inclusive of patients, patient advocates, the public and healthcare professionals to evaluate and confirm that a ‘patient-first’ approach was taken in the writing, design, and layout to help patients and caregivers understand the trial results.

The PLSP highlights the DESTINY-Breast01 clinical study. Both parts were open label, meaning that the participants, researchers, study doctors, and other staff knew what each participant was receiving. Part 1 was conducted to find out how T-DXd acted in the body, and to choose a dose to give to all participants in Part 2. To do this, the doctors gave different doses to the participants in Part 1 and took blood samples at different times during the study. In Part 1, the researchers used a computer program to randomly choose which dose of T-DXd each participant received. This helped make sure the doses were chosen fairly and comparing the results of the doses was as accurate as possible.

Study participants included 253 women aged 18 and older who had HER2 positive breast cancer that was metastatic or unresectable, had previous treatment with T-DM1, and were able to move around easily or were fully active. Study participants were from Belgium, France, Italy, Japan, South Korea, Spain, United Kingdom and the United States.

The results from Part 1 identified the recommended T-DXd dose of 5.4mg/kg for Part 2. In Part 2, T-DXd 5.4mg/kg was tested for its effect on tumor growth. T-DXd at 5.4mg/kg reduced tumor growth by more than 30% or caused the tumor to disappear in up to 60.9% (112 out of 184) of participants who had already received treatment with T-DM1 for their metastatic or unresectable HER2 positive breast cancer. Treatment response lasted nearly 15 months on average.

Serious adverse events occurred in 22.8% (42 out of 184) of patients during treatment with T-DXd in Part 2 of the study, with 15.2% (28 out of 184) of patients discontinuing treatment due to the adverse event. Adverse events that led to death included general deterioration in physical health (0.5%), pneumonia (0.5%), organ failure (0.5%) and shut down due to loss of blood (0.5%). There were two cases of interstitial lung disease (1.1%) that were considered to be related to the study treatment.

Read the full PLSP in Future Oncology here: https://www.futuremedicine.com/doi/pdf/10.2217/fon-2021-0427

About the Center for Information and Study on Clinical Research Participation (CISCRP)

CISCRP is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy. CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners. http://www.CISCRP.org

About Oxford PharmaGenesis

Oxford PharmaGenesis is comprised of a team of passionate and experienced individuals wholly committed to helping clients bring new treatments to the world in areas of unmet medical need. Their clients are diverse, spanning multiple therapy areas, functions and geographies. They work with more than 50 healthcare organizations, including specialist devices, diagnostics and nutraceuticals companies, and professional societies, patient groups and academic institutions. They are a preferred supplier to 9 of the top 10 global pharmaceutical companies and have worked with 8 of their top 10 client companies for more than 5 years. Learn more here: https://www.pharmagenesis.com/

PR Contact:

Joan Chambers, Senior Director, Marketing

jchambers@ciscrp.org

617-725-2750 (Ext. 202)

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