Significantly superior tumor response rate (ITT)

Reconciled target lesion response rate for ITT population

Visible response rate in relapsed or refractory patients

Reconciled target lesion response rate for relapsed and refractory patients
ITT=intent-to-treat.

In the ITT population, there was no statistically significant difference in overall survival between the two study arms

  • recTLRR was the prospectively defined, protocol-specific end point, 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 recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy
Trial Design
aFrom Cochran-Mantel-Haenszel test stratified by first-line vs >first-line therapy.
bPrior therapy included an anthracycline unless clinically contraindicated.

Significantly superior tumor response rate (ITT)

Reconciled target lesion response rate for ITT population

Visible response rate in relapsed or refractory patients

Reconciled target lesion response rate for relapsed and refractory patients
ITT=intent-to-treat.

In the ITT population, there was no statistically significant difference in overall survival between the two study arms

  • recTLRR was the prospectively defined, protocol-specific end point, 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 recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy
Trial Design
aFrom Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.
bPrior therapy included an anthracycline unless clinically contraindicated.

INDICATION

ABRAXANE 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.

INDICATION

ABRAXANE 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.