Clinical trial · Interventional
Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDI4736
- description
- 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.
- interventionNames
- Drug: MEDI4736
Primary outcomes (1)
- measure
- Pathologic Complete Response (pCR)
- timeFrame
- Up to 26 weeks
- description
- Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0). The outcome was changed from 19 weeks at the time of results entry as the treatment period was actually 20 weeks and the outcome was assessed 4-6 weeks after treatment when surgery took place.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines. 2. Willing and able to provide written informed consent for voluntary participation in the trial. 3. Willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies. 4. Eighteen years of age or older on the day of signing informed consent. 5. Female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry. 6. Patients should have adequate organ function to tolerate chemotherapy, as defined by: * peripheral granulocyte count of \> 1,500/mm3 * platelet count \> 100,000/mm3 * hemoglobin \>9 g/dL * total bilirubin \< 1.5 x upper limit of normal (ULN) * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \< 1.5 x ULN * serum creatinine \< 1.5 x ULN or serum creatinine clearance \< 50mL/min * INR/PT/PTT each \< 1.5 x ULN * TSH within normal limits Exclusion Criteria: 1. Patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node. 2. Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated. 3. Patients with active autoimmune disease or documented autoimmune disease within 2 years. Patients with hypothyroidism that is clinically stable and have normal TSH levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study. 4. Active or prior documented inflammatory bowel disease (Crohn's disease, ulcerative colitis). 5. Patients with known active hepatitis B or C or HIV infection or with history of tuberculosis.
References
Publications (0)
Data not yet available