|
| NCI ID | Status | Primary location | Study type | Setting adjuvant | Stage | Regimen |
|
| Chemotherapy |
| NCT00861705 | Recruiting | Miriam Hospital (Providence, RI) | Phase II | Neoadjuvant | II-III | Arm A: Paclitaxel D1 weekly × 12 weekly → ddAC D1 × 4 cycles |
| Arm B: Arm A + Bevacizumab q2wks (weeks 1, 3, 5, 7, 9, 10, 11, 13, 15, 17) |
| Arm C: Arm A + Carboplatin q3wks (wks 1, 4, 7, 10 |
| Arm D: Arm A + Bevacizumab as in Arm B + Carboplatin as in Arm C. |
| NCT00912444 | Recruiting | Shanghai Jiao Tong University School of Medicine (Shanghai, China) | Phase III | Neoadjuvant | T2N1 OR T3-4/N0-3 OR T0-4/N2-3 | Arm A: Docetaxel 75 mg/m2 & Doxorubicin 50 mg/m2 OR Epirubicin 60 mg/m2 & Cyclophosphamide 500 mg/m2 D1 × 6 cycles (cycle = 21 days) |
| Arm B: Docetaxel 75 mg/m2 & Cyclophosphamide 500 mg/m2 D1 × 6 cycles (cycle = 21 days) |
| NCT01112826 | Recruiting | Sun Yat-sen University Cancer Center (Guangzhou, China) | Phase III | Adjuvant | T1c-T3, pN0-2 | Arm A: Standard adjuvant chemotherapy followed by capecitabine 650 mg/m2 BID × 1 yr |
| Arm B: standard adjuvant chemotherapy |
| NCT00789581 | Active/Not recruiting | Sarah Cannon Research Institute (Nashville, TN) | Phase III | Adjuvant | Node negative T1c-T3 OR Node positive pN1mi -N2b) | Arm A: Doxorubicin 60 mg/m2 & Cyclophosphamide 600 mg/m2 D1 × 4 cycles (cycle = 21 days) → Ixabepilone at 40 mg/m2 D1 × 4 cycles (cycle = 21 days) |
| Arm B: Doxorubicin 60 mg/m2 & Cyclophosphamide 600 mg/m2 D1 × 4 cycles (cycle = 21 days) → Paclitaxel at 80 mg/m2 D1 weekly × 12 weeks |
| NCT00630032 | Active/Not recruiting | Centre Regional Rene Gauducheau (Nantes-Saint Herblain, France) | Phase III | Adjuvant | Node-positive disease OR node-negative disease: II-III OR pT1-4 | Arm A: Epirubicin & 5-Fluorouracil & Cyclophosphamide D1 × 3 cycles (cycle = 21 days) → Docetaxel D1 × 3 cycles (cycles = 21 days) |
| Arm B: Epirubicin & 5-Fluorouracil & Cyclophosphamide D1 × 3 cycles (cycle = 21 days) → Ixabepilone D1 × 3 cycles (cycles = 21 days) |
| NCT01216111 | Available | Fudan University (Shanghai, China) | Expanded Access | Adjuvant | I-IIIA | Paclitaxel 100 mg/m2 & Cisplatin AUC = 2 D1, 8, 15 × 6 cycles (cycle = 28 days) |
| NCT01276769 | Recruiting | Cancer Institute Hospital/Chinese Academy of Medical Sciences (Beijing, China) | Phase II | Neoadjuvant | IIa-IIIc (no T4 disease) | Arm A: Paclitaxel 175 mg/m2 D3 & Epirubicin 75 mg/m2 D 1, 2 × 2–6 cycles (cycle = 21 days) |
| Arm B: Paclitaxel 175 mg/m2 D1 & Carboplatin AUC = 5 D2 × 2–6 cycles (cycle = 21 days) |
| NCT01216124 | Available | Fudan University (Shanghai, China) | Expanded Access | Neoadjuvant | I-IIIA | Docetaxel 75 mg/m2 D1 & Oxaliplatin 130 mg/m2 D2 × 6 cycles (cycle = 21 days) |
| NCT01238133 | Recruiting | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center (Columbus, OH) | Phase I | Neoadjuvant | II-III | RO4929097 D1-3, 8-10, 15-17 & Paclitaxel D1, 8, 15 & Carboplatin D1 × 6 cycles (cycle = 21 days) |
| NCT01167192 | Recruiting | Washington University School of Medicine (St. Louis, MO) | Phase II | Neoadjuvant | T2-T4, any N | Cisplatin 75 mg/m2 IV or Carboplatin AUC = 6 IV, at physician discretion) + XRT × 6 weeks (50–60 Gy to breast/CW; 45–50 Gy to internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins) |
|
| Antiangiogenic agents |
| NCT00861705 | Recruiting | Miriam Hospital (Providence, RI) | Phase II | Neoadjuvant | II-III | Arm A: Paclitaxel D1 weekly × 12 weekly → dd AC D1 × 4 cycles |
| Arm B: Arm A + Bevacizumab q2wks (weeks 1, 3, 5, 7, 9, 10, 11, 13, 15, 17) |
| Arm C: Arm A + Carboplatin q3wks (wks 1, 4, 7, 10 |
| Arm D: Arm A + Bevacizumab as in Arm B + Carboplatin as in Arm C. |
| NCT01208480 | Recruiting | Severance Hospital (Seoul, Korea) | Phase II | Neoadjuvant | II-III | Bevacizumab & Docetaxel & Carboplatin D1 × 5 cycles (cycle = 21 days → Docetaxel & Carboplatin C6D1 |
| NCT00777673 | Recruiting | University of Tennessee Cancer Institute (Memphis, TN) | Phase II | Neoadjuvant | T2-T3, cN1-cN2a | Nab-paclitaxel D1, 8, 15 & Carboplatin D1 & Bevacizumab D1,15 × 4 cycles (cycle = 28 days) → ddAC × 4 cycles (cycle = 14 days) & Bevacizumab D1 × 2 cycles (cycle = 14 days) |
| >4 weeks postoperative: Bevacizumab D1, 15 × 8 cycles (cycle = 28 days) |
| NCT00528567 | Recruiting | Hoffmann-La Roche; International | Phase III | Adjuvant | Operable primary invasive breast cancer | Arm A: Standard adjuvant chemotherapy (anthracycline ± taxane or taxane only) & 1 yr of Bevacizumab 5 mg/kg/week dosing equivalent |
| Arm B: Standard adjuvant chemotherapy (anthracycline ± taxane or taxane only) |
| NCT00887575 | Recruiting | Tennessee Oncology, PLLC (Nashville, TN) | Phase I/II | Neoadjuvant | T1-3, any N (excluding T1N0) | Paclitaxel D1, 8, 15 & Carboplatin D1 & Sunitinib D1-21 × 6 cycles (cycle = 28 days) |
| NCT01194869 | Recruiting | Emory University (Atlanta, GA) | Phase II | Neoadjuvant | I-IIIA | Sorafenib 400 mg BID throughout the study: single agent for weeks 1–4, then in combination with cisplatin followed by dose dense paclitaxel |
| Poly(ADP-ribose) polymerase (PARP) inhibitors |
| NCT00813956 | Recruiting | Stanford Comprehensive Cancer Center (Stanford, CA) | Phase II | Neoadjuvant | I-IIIA | Gemcitabine & Carboplatin & BSI-201 q3wks |
| NCT01204125 | Recruiting | Grupo Espanol de Estudio Tratamiento y Otras Estrategias Experimentales en Tumores Solidos (France/Spain) | Phase II | Neoadjuvant | II-IIIA | Arm A: Iniparib 5.6 mg/kg D1, 4 &Paclitaxel 80 mg/m2 D1 weekly × 12 weeks |
| Arm B: Iniparib 11.2 mg/kg D1 &Paclitaxel 80 mg/m2 D1 weekly × 12 weeks |
| Arm C: Paclitaxel 80 mg/2 D1 weekly × 12 weeks |
| NCT01074970 | Recruiting | Indiana University Melvin and Bren Simon Cancer Center (Indianapolis, IN) | Phase II | Adjuvant | Residual disease post neoadjuvant chemotherapy (I-III) | Arm A: PF-01367338 D1-3 C1: 30mg C2-4: 24 mg & Cisplatin 75 mg/m2 D1 × 4 cycles (cycle = 21 days) |
| Arm B: Cisplatin 75 mg/m2 D1 × 4 cycles (cycle = 21 days) |
|
| EGFR inhibitors |
| NCT01097642 | Recruiting | The Methodist Hospital Research Institute (Houston, TX) | Phase II | Neoadjuvant | T1N1-3M0 or T2-4 N0-3M0 | Arm A: Cetuximab 400 mg/m2 D1 then weekly 250 mg/m2 & Ixabepilone 40 mg/m2 D1 1 × 4 cycles (cycle = 21 days) |
| Arm B: Ixabepilone 40 mg/m2 D1 1 × 4 cycles (cycle = 21 days) |
| NCT00600249 | Recruiting | Centre Jean Perrin (Clermont-Ferrand, France) | Phase II | Neoadjuvant | II-IIIa | Cetuximab Wk1D1 400 mg/m2 → 250 mg/m2 D1 weeks 2–18.
& Docetaxel 100 mg/m2 D1 × 6 cycles (cycle = 21 days) |
| NCT00491816 | Active/Not recruiting | University of Kansas Medical Center (Kansas City, KS) | Phase II | Neoadjuvant | II-III (T2-4, N1-2) | Erlotinib150 mg orally D3-14 with cycles 1 to 6 or 3 to 6 of neoadjuvant chemotherapy. Adjuvant chemotherapy given at the discretion of treating physician followed by 1 yr of maintenance erlotinib 150 mg daily |
|
| Other targeted agents |
| NCT00930930 | Recruiting | Vanderbilt-Ingram Cancer Center (Nashville, TN) | Phase II | Neoadjuvant | II-III | Arm A: Cisplatin & Everolimus D1 weekly × 12 weeks & Paclitaxel D1 weekly in weeks 4–12 |
| Arm B: Cisplatin & Placebo D1 weekly × 12 weeks & Paclitaxel D1 weekly in weeks 4–12 |
| NCT00499603 | Active/Not recruiting | M.D. Anderson Cancer Center (Houston, TX) | Phase II | Neoadjuvant | IIa-IIIc | Arm A: Drug: Paclitaxel 80 mg/m2 D1 weekly & RAD001 30 mg D1, 8, 15 × 12 cycles (cycle = 21 days) → 5-Fluorouracil 500 mg/m2 & Epirubicin100 mg/m2 & Cyclophosphamide 500 mg/m2 D1 × 4 cycles (cycle = 21 days) |
| Arm B: Paclitaxel 80 mg/m2 D1 weekly × 12 cycles (cycle = 21 days) → 5-Fluorouracil 500 mg/m2 & Epirubicin100 mg/m2 & Cyclophosphamide 500 mg/m2 D1 × 4 cycles (cycle = 21 days) |
|
