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Also known as Adriamycin
Adriamycin and Cytoxan · 2 trials · 1 indication
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 |
|---|---|---|
| Herceptin | DRUG | Given intravenously once weekly for 12 weeks prior to surgery. |
| Taxol | DRUG | Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery. |
| Adriamycin | DRUG | Given every three weeks for 12 weeks after surgery. |
| Cytoxan | DRUG | Given every three weeks for 12 weeks after surgery. |
| 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) |
| 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: * Patients must have Stage II or III histologically diagnosed breast cancer * Primary invasive breast cancers that overexpress the HER2/neu oncogene * Age older than 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 * White blood cell (WBC) \> 4000/...
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Adriamycin and Cytoxan, commonly called AC, is a combination chemotherapy regimen studied for breast cancer. It has been evaluated as adjuvant therapy after surgery and in the neoadjuvant setting before surgery. Both clinical trials listed for this regimen enrolled patients with breast cancer in the United States.
Adriamycin and Cytoxan is associated with Bristol-Myers Squibb Company, which trades under the ticker BMY. The regimen combines two small molecule chemotherapeutic agents, and Bristol-Myers Squibb is identified as the developer of the Adriamycin and Cytoxan combination.
Adriamycin and Cytoxan is in Phase 2 clinical development for breast cancer. It is an investigational regimen rather than an approved product for the studied uses. Two Phase 2 trials have been recorded, one completed and one completed, with no active trials currently listed.
Two Phase 2 breast cancer trials are registered for Adriamycin and Cytoxan. NCT00394251 studied dose-dense AC followed by either ABI-007 (Abraxane) or Taxol with bevacizumab as adjuvant therapy, enrolling 197 patients. NCT00136539 evaluated neoadjuvant therapy with Herceptin and Taxol for breast cancer, enrolling 41 patients. Both trials were conducted in the United States and are completed.
Yes, Adriamycin and Cytoxan is commonly abbreviated as AC, and Adriamycin is also used as a shorthand name for the regimen. The AC abbreviation reflects the two components, Adriamycin and Cytoxan, given together as a combination chemotherapy regimen in breast cancer studies.
Across the two registered Phase 2 trials, 238 patients have been enrolled in studies of Adriamycin and Cytoxan for breast cancer. NCT00394251 enrolled 197 patients and NCT00136539 enrolled 41 patients. Both studies were controlled and enrolled adults aged 18 years and older.