Neoadj DatoDXd+Durvalumab&AdjDurvalumab w/w/out ChemoVSNeoadj Pembro+Chemo&AdjPembro w/w/out ChemoTx

UCI Specialty Area: Cancer

Principal Investigator: Ritesh Parajuli

Official Title: A Phase III, Open-Label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-Low/HER2-Negative Breast Cancer (D926QC00001; TROPION-Breast04)

A Study On:

Breast

Study Description

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Eligibility

You can participate in this study if you:

Participant must be > or equal to 18 years, at the time of signing the ICF.
Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
ECOG PS of 0 or 1
Provision of acceptable tumor sample
Adequate bone marrow reserve and organ function
Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You cannot participate in this study if you:

History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
Evidence of distant disease.
Clinically significant corneal disease.
Has active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
Known to have active tuberculosis infection
Resting ECG with clinically significant abnormal findings.
Uncontrolled or significant cardiac disease.
History of non-infectious ILD/pneumonitis
Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

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