Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00394251 | Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer | PHASE2 | COMPLETED | 197 | — | — | Aug 1, 2006 | Feb 1, 2008 | Nov 25, 2019 | 27 | United States |
Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7).
Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of \>=20% in any treatment arm, and participants with at least one toxicity are reported. Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10). Entire regiments (AC --\> ABI-007 and AC --\> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10).
| Arm | Type | Description |
|---|---|---|
| AC --> ABI-007 | EXPERIMENTAL | Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m\^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46). |
| AC --> Taxol | EXPERIMENTAL | Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m\^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46). |
| Name | Type | Description |
|---|---|---|
| Adriamycin and Cytoxan (AC) | DRUG | Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide) make up the chemotherapy regimen known as AC. Adriamycin 60 mg/m\^2 intravenous, plus Cytoxan 600 mg/m\^2 intravenous on Day 1 of each of four 2-week cycles (weeks 1-8). |
| ABI-007 | DRUG | 260 mg/m\^2 IV on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) |
| Taxol | DRUG | 175 mg/m\^2 intravenously (IV) on day 1 of each of four 2-week cycle, representing treatment cycles 5-8 (weeks 9-16) |
| Bevacizumab | DRUG | 10 mg/kg on day 1 of each of eight 2-week cycles (weeks 9-16), then 15 mg/kg on day 1 of each of ten three-week cycles (weeks 17-46). |
| pegfilgrastim | DRUG | 6 mg subcutaneous (SC) on day 2 for each of the first four 2-week cycles (weeks 1-8). Pegfilgrastim 6 mg SC was administered on day 2 of cycles 6-8 (weeks 11-16) during taxane treatment only if necessary. |
Inclusion Criteria: A patient was eligible for inclusion in this study only if all of the following criteria were met: 1. Female, age greater than or equal to 18 to less than or equal to 70 years old. 2. Estrogen receptor (ER) and progesterone receptor (PR) status have been determined. 3. Operable...