Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

Launched by CELGENE CORPORATION · Jan 12, 2016

Keywords

ClinConnect Summary

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.

The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemoth...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women ≥18 years of age.
• • Confirmed diagnosis of MBC (stage IV).
• • Breast adenocarcinoma confirmed histologically.
• • HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
• • Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
• • Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).
• Exclusion Criteria:
• • Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
• • Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
• • Patients who have taken part in any clinical trial (interventional) during the study period.