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ABP 980 · 1 trial · 1 indication
Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS). Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites.
| Arm | Type | Description |
|---|---|---|
| ABP 980 | EXPERIMENTAL | Participants received ABP 980 at an initial dose of 8 mg/kg by intravenous (IV) infusion, then 6 mg/kg IV infusion every 3 weeks (Q3W) for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase. Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. After surgery (adjuvant phase) participants continued receiving 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. |
| Trastuzumab | ACTIVE_COMPARATOR | Participants received trastuzumab at an initial dose of 8 mg/kg IV infusion, then 6 mg/kg IV infusion Q3W for 3 additional cycles plus 175 mg/m² paclitaxel Q3W for 4 cycles during the neoadjuvant phase. Surgery (lumpectomy or mastectomy with sentinel lymph node dissection or axillary lymph node dissection) was completed 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. After surgery (adjuvant phase) participants were re-randomized to either continue receiving 6 mg/kg trastuzumab IV Q3W or transition to 6 mg/kg ABP 980 IV Q3W for up to 1 year from the first day of study drug administration in the neoadjuvant phase. |
| Name | Type | Description |
|---|---|---|
| ABP 980 | DRUG | ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles. |
| Trastuzumab | DRUG | Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles. |
| Paclitaxel | DRUG | Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care). |
| Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection | PROCEDURE | - |
Inclusion Criteria: * Females ≥ 18 years of age * Histologically confirmed invasive breast cancer * Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection * Planning neoadjuvant chemotherapy * HER2 positive disease * Measurable disease in the breast after...
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ABP 980 is being developed for the treatment of HER2-positive early breast cancer. It was studied in women with this condition as a potential biosimilar to trastuzumab. The clinical program focused on comparing its efficacy and safety against trastuzumab in a Phase 3 trial.
ABP 980 is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program for this investigational product.
ABP 980 has completed a Phase 3 clinical trial. It is an investigational product and has not been approved by the FDA. The Phase 3 study was completed, and no active trials are currently listed for this drug.
ABP 980 was evaluated in a single Phase 3 trial, NCT01901146, titled "Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer." The trial enrolled 725 participants and was completed.
ABP 980 is not the same as trastuzumab; it is a proposed biosimilar to trastuzumab. It was compared directly with trastuzumab in a Phase 3 trial to assess similarity in efficacy and safety. ABP 980 is an investigational product and is not approved.