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TReatment of ADC-Refractory Breast CancEr with Dato-DXd or T-DXd: TRADE DXd

The purpose of this study is to test the safety and eff ectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan; or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating your type of cancer. Additional information collected from this study may also help inform the future use of these drugs.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

You will have tests, exams and procedures part of your standard care and for study purposes. These will include clinic visits, lab draws, pregnancy test (if applicable), ECGs, scans, eye exams, ECHO, biopsies, questionnaires and receipt of study medications.

In-person visits:
All screening, imaging and treatment visits are in person

Phone or online visits:
Survival follow up visits can be done in person or by phone call

Total length of participation:
Treatment continues until disease progression or subject withdrawal.

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with unresectable locally advanced or metastatic HER2-low breast
You are willing to undergo research biopsies of your cancer tissue.
Your breast cancer has progressed on or received at least one line of endocrine therapy and
You have completed prior radiation therapy at least 14 days before treatment, if applicable.

Not eligible if:

You are currently receiving other investigational products to treat your breast cancer.
You have clinically significant corneal disease.
You have had major surgery within 2 weeks of starting study treatment
You are pregnant or breastfeeding.
You have a history of pneumonitis that required steroids

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

24-3069

ClinicalTrials.gov

NCT06533826

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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Questions?

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