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Study of sacituzumab govitecan with or without pembrolizumab in Metastatic TNBC

To compare the progression-free survival of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients triple negative metastatic breast cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

The study involves blood draws, CT/MRI Scans, 3 biopsies (1 optional), stool samples and questionnaires, receipt of study drugs. You will meet with a member of the study team in addition to your oncology care team during your visits.

Incentives

Study medication

Total length of participation:
Treatment until disease progression or unacceptable toxicity; follow up period until death, contacted every 6 months for survival.

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of metastatic triple negative breast cancer
You must agree to have a biopsy for the study prior to treatment and a biopsy 3-6 weeks after starting the study
You have not received treatment for your metastatic breast cancer
Your breast cancer is PD-L1 negative

Not eligible if:

You have had major surgery within 2 weeks before starting the study
You have been diagnosed with an autoimmune disease
You are receiving oral or IV steroid therapy
You have a history of HIV, Hepatitis B or C

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
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

20-3677

ClinicalTrials.gov

NCT04468061

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Questions?

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