BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY
BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY

*Most common dominant sites of metastasis.


- *Most common dominant sites of metastasis.


Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses 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. The secondary endpoints were time to disease progression and overall survival.
- IV=intravenously; PS=performance status; Q3W=every 3 weeks; recTLRR=reconciled target lesion response rate.
- A Rigorous Primary Efficacy Endpoint
PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR
PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR
-
The primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
– recTLRR was based on independent radiologic assessment of tumor responses
– recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapyThe primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
- recTLRR was based on independent radiologic assessment of tumor responses
- recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapy
- Secondary efficacy endpoints included time to disease progression and overall survival, among other measures24
- An exploratory analysis was conducted for overall survival to evaluate the subgroup of patients receiving ABRAXANE as second-line or later therapy
Patients who completed 6 cycles of ABRAXANE therapy and did not progress were able to continue treatment at the investigator's discretion.24
-
- NCCN Recommendation
RECOMMENDATIONS FOR METASTATIC BREAST CANCER PATIENTS WITH VISCERAL METASTASES
The predominance of visceral metastases in the Phase III study is consistent with the National Comprehensive Cancer Network® (NCCN®) recommended* patient population for albumin-bound paclitaxel (ABRAXANE)3
*NCCN Guidelines® (V.6.2020) recommend albumin-bound paclitaxel as Category 2A.
YOU ARE NOW LEAVING www.abraxanepro.com
Additional Information for Readers Provided by Celgene Corporation
The clinical trial described in this article served as the
basis for the approval for ABRAXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.
Please see Important Safety Information and Prescribing Information, including Boxed WARNING.
Click “OK” to proceed or “CANCEL” to return to
www.abraxanepro.com
YOU ARE NOW LEAVING www.abraxanepro.com
Additional Information for Readers Provided by Bristol Myers Squibb
The clinical trial described in this article served as the
basis for the approval for ABRAXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.
Please see Important Safety Information and Prescribing Information, including Boxed WARNING.
Click “OK” to proceed or “CANCEL” to return to
www.abraxanepro.com
YOU ARE NOW LEAVING www.abraxanepro.com
Click “OK” to proceed or “CANCEL” to return to
www.abraxanepro.com
FOR HEALTHCARE PROFESSIONALS
The information contained in this section of www.abraxanepro.com is technical in nature and is intended for US healthcare professionals only.
If you are not a US healthcare professional, click “CANCEL” below to return to the patient and caregiver section of the site. Click “OK” if you are a healthcare professional.
OK CANCELFOR HEALTHCARE PROFESSIONALS
The information contained in this section of www.abraxanepro.com is technical in nature and is intended for US healthcare professionals only.
If you are not a US healthcare professional, click “CANCEL” below to return to the patient and caregiver section of the site. Click “OK” if you are a healthcare professional.
OK CANCEL