At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed histologically confirmed stage I-III triple-negative breast cancer (ER, PR, HER2 negative)
- ✓Age ≥18 years
- ✓Willing to undergo baseline tumor core needle biopsy and blood draws for correlative studies
- ✓Adequate organ function to tolerate chemotherapy
- ✕Prior breast surgery (partial excisional biopsy, lumpectomy, segmental mastectomy, modified radical mastectomy, or sentinel node biopsy)
- ✕Contraindication to anthracycline, paclitaxel, or antibody therapies
- ✕Active autoimmune disease or documented autoimmune disease within 2 years (exceptions: stable hypothyroidism with normal TSH, vitiligo or psoriasis not requiring treatment)
- ✕Active or prior inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single Arm Neoadjuvant Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant With Weekly Nab-paclitaxel and Dose-dense Doxorubicin/Cyclophosphamide (ddAC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating MEDI4736 for Breast Neoplasms. Completed, enrolled 68 participants across 1 site.
Detailed Summary
The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736 concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete response (pCR) rate (\>55%) in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2 respectively).
Study Details
Timeline
Interventions
The investigational product is MEDI4736 which will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous (IV) administration. Routine, standard of care chemotherapy will be given together with the investigational product and will include weekly nab-paclitaxel x12 treatments followed by every two-week doxorubicin, cyclophosphamide (ddAC) x 4 treatments.