In this trial, patients in the ABRAXANE® treatment arm had a statistically significantly higher reconciled target lesion response rate (the trial primary endpoint) of 21.5% (95% CI: 16.2% to 26.7%), compared to 11.1% (95% CI: 6.9% to 15.1%) for patients in the paclitaxel injection treatment arm. See Table 2. There was no statistically significant difference in overall survival between the two study arms.

Table 2: Efficacy Results from Randomized Trial  ABRAXANE
260 mg/m2 Paclitaxel Injection
175 mg/m2
Reconciled Target Lesion Response Rate (primary endpoint) *
*
Reconciled Target Lesion Response Rate (TLRR) was the prospectively defined protocol specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The reconciled TLRR was lower than the investigator Reported Response Rates, which are based on all cycles of therapy.
†
From Cochran-Mantel-Haenszel test stratified by 1st line vs. > 1st line therapy.
‡
Prior therapy included an anthracycline unless clinically contraindicated. 
All randomized patients Response Rate
[95% CI] 50/233 (21.5%)
[16.19% – 26.73%] 25/227 (11.1%)
[6.94% – 15.09%]
P-value † 0.003
Patients who had failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy‡ Response Rate
[95% CI] 20/129 (15.5%)
[9.26% – 21.75%] 12/143 (8.4%)
[3.85% – 12.94%]

INDICATION
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

CONTRAINDICATIONS
ABRAXANE should not be used in patients who have baseline neutrophil counts of < 1,500 cells/mm3.

WARNINGS
Bone marrow suppression (primarily neutropenia) is dose dependent and a dose limiting toxicity. ABRAXANE should not be administered to patients with baseline neutrophil counts of < 1,500 cells/mm3. Frequent monitoring of blood counts should be instituted during ABRAXANE treatment. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.

The use of ABRAXANE has not been studied in patients with renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

Pregnancy

Teratogenic Effects

Pregnancy Category D
ABRAXANE can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel protein-bound particles to rats on gestation days 7 to 17 at doses of 6 mg/m2 (approximately 2% of the daily maximum recommended human dose on a mg/m2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina