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Lay Description

This clinical trial aims to validate the results observed in I-SPY2 and will test if adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in early-stage HR
positive MP2 cancers.

Category

  • Cancers and Other Neoplasms
IRB Number
STUDY00000106
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
-
Eligible Genders
All
Accepts Healthy Volunteers

Inclusion Criteria

Participants must have histologically confirmed ER positive and/or PR positive (hormone receptor positive) and HER2 negative breast cancer, as per ASCO CAP guidelines.   NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible.   2. Participants must have clinical stage II or III breast cancer. 

Exclusion Criteria

Study Design

Study Contact

Regulatory Point of Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Principal Investigator
Kate Lathrop