Table 3.
Ongoing Multicenter Clinical Trials Utilizing Antiangiogenic Agents in the Neoadjuvant Setting
| Trial Sponsor/Number | Title | Phase |
|---|---|---|
| HER2-Positive Tumors | ||
| NSABP FB-5 | A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer | II |
| Hoffmann-La Roche ML21531 | An Open Label Study to Assess the Rate of Pathologic Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy | II |
| HER2-Negative | ||
| NSABP FB-4 | A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally Advanced Breast Cancer | II |
| NSABP B-40 | A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens | III |
| CALGB-40603 | 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 | II |
| SWOG-S0800 | A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel) (NSC-736631) with or without bevacizumab, either preceded by or Followed by q 2 week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced HER-2/NEU Negative Breast Cancer | II |
| Hoffmann-La Roche ML19884 | An Open Label Neoadjuvant Study to Assess the Effect of Avastin on Tumor Response in Patients With Inflammatory or Locally Advanced Breast Cancer | II |
| Hoffmann-La Roche ML20561 | An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathologic Response Rate in Inflammatory or Locally Advanced Breast Cancer | II |
| Hoffmann-La Roche ML20382 | An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathologic Response in Patients With Primary Operable HER2 Negative Breast Cancer | II |
| Hoffmann-La Roche ML21744 | A Multicenter, Randomized, ph II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadj Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Ref to the Obtained Responses in Patients With Large Primary HER2 Neg Breast Cancers | II |
| TORI B-02 | A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer | II |
| German Breast Group GBG 45 | Phase II Study of Neoadjuvant Epirubicin, Cyclophosphamide (EC) + Sorafenib Followed by Paclitaxel (P) + Sorafenib in Women With Previously Untreated Primary Breast Cancer (SOFIA) | II |
| GSK 110264, NSABP FB-6 | A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently With Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women With Locally Advanced Breast Cancer | II |
| German Breast Group GBG 44 | A Phase III Trials Program Exploring the Integration of Bevacizumab, Everolimus (RAD001), and Lapatinib Into Current Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer | III |
| NCIC Clinical Trials Group CAN-NCIC-MA29 | A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients With T1c-T3 Operable Carcinoma of the Breasta | II |
a
HER2, ER, or PR status not specified.
Abbreviations: CALGB = Cancer and Leukemia Group B; GSK = GlaxoSmithKline; NCIC = National Cancer Institute of Canada; NSABP = National Surgical Adjuvant Breast and Bowel Project; SWOG = Southwest Oncology Group