Table 1.
Representative Neoadjuvant Trials in Triple Negative Breast Cancer
| Title | Regimen/Design | Population | Status | pCR rate (#/total) |
Sponsor | clinicaltrials.gov identifier and/or (Reference) |
|---|---|---|---|---|---|---|
| A Phase II Trial of Cisplatin in Early Stage ER−, PR−, HER-2 Negative Breast Cancer |
Cisplatin 75mg/m2 q3 wk × 4 | TNBC | Complete | 22% (6/28) | Dana-Farber Cancer Institute/Massachusetts General Hospital/Beth Israel Deaconess Medical Center |
NCT00148694, (45, 46) |
| A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER−, PR−, Her-2 Negative Breast Cancer |
Cisplatin 75 mg/m2 + bevacizumab 15mg/m3 q 3 week × 4 |
TNBC | Complete | 16% (8 /51) 37% Miller- Payne score 4 and 5 |
Massachusetts General Hospital/ Dana-Farber Cancer Institute/ Beth Israel Deaconess Medical Center/Genentech |
NCT00580333, (47) |
| Neoadjuvant therapy with cisplatin in BRCA1-positive breast cancer patients |
Cisplatin 75mg/m2 q3 wk × 4 | BRCA1 | Complete | 72% (18/25) | Pomeranian Medical University |
(53) |
| Randomized Phase II 2 × 2 Factorial Trial of the Addition of Carboplatin +/− Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose- Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer |
Randomized: Pacliataxel weekly +/−Carboplatin →AC, +/− bevacizumab |
TNBC (low HR) |
Ongoing | 362 (planned) | CALGB | NCT00861705 |
| Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer |
Retrospective, various regimens | TNBC, HER2+, ER+ |
Completed | TNBC – 22% (56/255), non-TNBC 11% (95/863) |
MD Anderson Cancer Center |
(12) |
| Breast cancer molecular subtypes respond differently to preoperative chemotherapy |
Retrospectivepaclitaxel weekly × 12→FAC × 4 |
Unselected (basal, luminal A/B, HER2+, normal-like |
Completed | Basal – 45% (10/22), HER2+ − 45% (9/11), Normal-like – 0% (0/10), Luminal 7% (2/28) |
MD Anderson Cancer Center |
(22) |
| Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer |
Doxorubicin 24mg/m2 IV + cyclophosphamide 60mg/m2 PO weekly × 12→ paclitaxel 80mg/m2 IV+ carboplatin IV AUC 2 weekly × 12 weeks |
TNBC | Ongoing | 28 (planned) | Leo W. Jenkins Cancer Center |
NCT00542191 |
| A Phase II Neo-Adjuvant Study of Cisplatin, Paclitaxel With or Without RAD001 in Patients With Triple-negative Locally Advanced Breast Cancer |
Randomized: cisplatin IV and +/−oral everolimus once weekly in weeks 1-12 and paclitaxel IV weekly in weeks 4-12 |
TNBC | Ongoing | 96 (planned) | Vanderbilt-Ingram Cancer Center |
NCT00930930 |
| Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer (NATT) |
Randomized: Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles OR Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles |
TNBC or HER2+ |
Ongoing | 600 (planned) | Shanghai Jiao Tong University School of Medicine |
NCT00912444 |
| Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy (Paclitaxel Followed by FEC) Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer (CRAD001C24101) |
Randomized: Paclitaxel +/− RAD001 Followed by FEC |
TNBC | Ongoing | 50 (planned) | M.D. Anderson Cancer Center/ Novartis |
NCT00499603 |
| A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients |
Randomized: EC q 3 wk × 4 →docetaxel q 3 wk × 4 OR carboplatin AUC 6 q 3 wk × 4 |
TNBC, ER+ | Ongoing | 188 (planned) | Spanish Breast Cancer Research Group/AstraZeneca/Pfizer |
NCT00432172 |
| Neoadjuvant Weekly Nab-Paclitaxel (Abraxane®) Plus Carboplatin Followed By Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently To Chemotherapy For Palpable And Operable Triple Negative Invasive Breast Cancer |
nab-paclitaxel IV on days 1, 8, and 15, Carboplatin IV on day 1, Bevacizumab IV on days 1 and 15, × 4 cycles → Doxorubicin IV, Cyclophosphamide IV every 14 days × 4 cycles + bevacizumab IV every 14 days ×2. |
TNBC | Planned | 60 | University of Tennessee Cancer Institute/ NCCN/ Abraxis/ Genentech |
NCT00777673 |