Study Details

Open

ASCENT-05/GS-US-595-6184:A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early TNBC when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

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

Location

North Carolina (Statewide)

What will be asked of you

This study involves blood draws, physical exams, pregnancy testing (if female), urine samples, ECG and ECHO or MUGAs, completion of questionnaires and receipt of study medication. Patient who complete study treatment will move into long term follow up and will be contacted annually by the study team.

Incentives

Study Medication

Total length of participation:
Varies from 1 day to up to 10 years. Depending on how you respond to treatment.

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with triple negative breast cancer and have residual disease after receiving preoperative treatment and surgery.
You received at least 6 cycles of preoperative therapy for your triple negative breast cancer.
There have not been more than 16 weeks since your surgery for your breast cancer and date of randomization for the study.
You have recovered from your breast surgery.
If you have received radiation therapy, you have recovered prior to starting study treatment.

Not eligible if:

You have metastatic triple negative breast cancer.
Your breast cancer has come back after preoperative therapy and surgery.
You are receiving other investigational drugs or devices.
You are pregnant or breastfeeding.
You have an active autoimmune disease that has required treatment within the past 2 years.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

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

23-1869

ClinicalTrials.gov

NCT05633654