Table 2.
Selected Ongoing Neoadjuvant Clinical Trials in TNBC
| NCT number | Phase | Treatment Intervention |
|---|---|---|
| Taxanes | ||
| NCT04137653 | III | Nab-Paclitaxel and Carboplatin vs Paclitaxel and Carboplatin in neoadjuvant TNBC |
| NCT02897050 | II | Docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX) followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC |
| Platinum agents | ||
| PEARLY NCT02441933 |
III | Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With TNBC |
| NeoSTOP NCT02413320 |
II | Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by Doxorubicin Plus Cyclophosphamide in Stage I-III TNBC |
| NCT03154749 | II | TC (Docetaxel/Carboplatm) Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as NACT for TNBC |
| NCT04083963 | II | BRE-01: Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel Followed by Doxorubicin and Cyclophosphamide in TNBC |
| Immune checkpoint inhibitors | ||
| NSABP B-59/GBG 96-GeparDouze NCT03281954 |
III | Atezoiizumab or Placebo with paclitaxel and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) in Patients with TNBC Followed by Adjuvant Continuation of Atezoiizumab or Placebo |
| IMpassion 031 NCT03197935 |
III | Randomized Study to Investigate the Efficacy and Safety of Atezoiizumab versus Placebo in Combination with Neoadjuvant Anthracycline/Nab- Paclitaxel-Based Chemotherapy in TNBC |
| NeoPACT NCT03639948 |
II | Neoadjuvant Pembrolizumab And Carboplatin Plus Docetaxel in TNBC |
| NCT04243616 | II | Study of PD-1 Inhibition with Cemiplimab in Locally Advanced Hormone Receptor (HR) Positive HER2 Negative or TNBC Patients Undergoing Standard NACT |
| NCT04213898 | I/II | SHR-1210 (anti- PD1 inhibitor) Combined with Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for TNBC |
| NCT03356860 | I/II | A Phase IB/II Study of Durvalumab Combined with Dose-dense EC ollowing Paclitaxel in a Neoadjuvant Setting for Patients with Locally dvanced Eliminai B HER2(-) or TNBC |
| NCT02489448 | I/II | Neoadjuvant MEDI4736 Concomitant with Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III TNBC |
| NCT04331067 | I/II | Cabiralizumab* in Combination with Nivolumab and paclitaxel/Carboplatin NACT in Patients with Localized TNBC |
| PARP inhibitors | ||
| PARTNER NCT03150576 |
II/III | Evaluate the Safety and Efficacy of the Addition of Olaparib to Platinum- based NACT in Patients with TNBC and/or gBRCA. |
| NCT03329937 | I | Evaluate the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients |
| Androgen Receptor anitagonists | ||
| NCT02689427 | II | Enzalutamide and Paclitaxel Before Surgery in Treating Patients with Stage I–II Androgen Receptor-Positive TNBC |
| NCT02676986 | II | Study of Short-term Preoperative Treatment with Enzalutamide (Alone or in Combination with Exemestane) in Patients with Primary Breast Cancer (HR+ and TNBC) |
*
Anti-colony stimulating factor 1 receptor (CSF1R) antibody