This phase 3 trial aims to compare an investigational drug to standard chemotherapy in breast cancer patients with brain metastases. The main outcome to be investigated is overall survival (time from treatment until death from any cause). Another outcome to be measured is progression free survival (time from treatment until disease progression). This trial is taking place in Israel, Spain, UK and various states in USA.
The details
NKTR-102 is an investigational form of the chemotherapy irinotecan combined with a topoisomerase inhibitor. It is thought that this drug could be more effective than standard chemotherapy.
The study will evaluate the effectiveness of this drug by looking at the overall survival rates.
Who are they looking for?
This study will recruit 350 patients who have breast cancer with a non-progressing brain metastases. Patients must have had treatment with an anthracycline, taxane and capecitabine (chemotherapies). Female patients must be willing to use birth control for the duration of the study.
Patients who have had anticancer therapy, chemotherapy followed by stem cell therapy or major surgery within 2 to 4 weeks will be excluded. Patients with gastrointestinal disorders, cardiovascular disorders, HIV, hepatitis C, hepatitis B or tuberculosis are not eligible. Patients receiving daily oxygen or those with a psychiatric illness cannot participate.
How will it work
Patients will be randomly divided into 2 groups. One group will receive NKTR-102 every 21 days. The other will receive standard chemotherapy, which may be eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
The effectiveness of NKTR-102 will be measured by comparing the overall survival rates for both groups. Patients will be followed for up to 3 years.
