Conditions: Breast Cancer
Keywords: Locally Advanced Breast Cancer Inflammatory Breast Cancer Breast Cancer Abraxane nab Paclitaxel Epirubicin Gemcitabine Gemzar
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 123
Healthy volunteers: no

Brief summary:
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Detailed description:
Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Arms:
arm 1: Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy.

Interventions: intervention 1: Gemcitabine intervention 2: Epirubicin intervention 3: Albumin-bound Paclitaxel
Intervention descriptions: intervention 1: Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles intervention 2: Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles intervention 3: ABI-007 175 mg/m2 D1 q 14 days x 6 cycles

Protocol document: