Open

A Phase 3 Study of DB-1303 vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Posit

This study will investigate the safety and efficacy of a new drug DB-1303 against standard treatment procedure in patients with metastatic breast cancer. This study will also evaluate the efficacy of a diagnostic test that will be performed during the trial.

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

The study involves study drug infusions, physical examinations, pulmonary function tests, tissue, blood and urine sample collections, ECG, ECHO/MUGA scan, eye examination, CT scans/MRI with or without X-rays, bone scans.

In-person visits:
5-20

Phone or online visits:
0-5

Total length of participation:
2-4 years of active participation with long term follow-up

Looking for Specific Volunteers

Able to participate:

You have hormone receptor-positive (HR+) breast cancer
You have been told your breast cancer is HER2-low
Your breast cancer that has spread to other parts of your body
You have not received chemotherapy for advanced or metastatic breast cancer
Your breast cancer has progressed after receiving therapy

Not eligible if:

You are not able to receive capecitabine, paclitaxel, and nab-paclitaxel treatment
You have uncontrolled ongoing illness
You have active HIV, hepatitis B or C infection
You are pregnant or breastfeeding
You have history of another cancer

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Claire Dees
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

24-0522

ClinicalTrials.gov

NCT06018337

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.

Helpful Links

Questions?

This email address is being protected from spambots. You need JavaScript enabled to view it.