S2206, Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer
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
- NCT # not yet entered
Eligibility
- Eligible Ages
- 18
- 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
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Jessica Villarreal
villarreal24@uthscsa.edu
Principal Investigator
Kate Lathrop