A Randomized Phase 2 Trial of AEZS-108 in Chemotherapy Refractory Triple Negative, LHRH-positive Metastatic Breast Cancer.

NCT01698281 Phase 2 TERMINATED

This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.

Details

Lead sponsor	AEterna Zentaris
Phase	Phase 2
Status	TERMINATED
Enrolment	7
Start date	2012-12
Completion	2014-10

Conditions

• Breast Cancer

Interventions

• AEZS-108
• SCCC
• Dexamethasone

Primary outcomes

• Efficacy of AEZS-108 compared to SSCC as measured by the median time of progression-free survival (PFS). — Up to two years
  PFS is defined as the time elapsed from randomization to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.

Countries

United States, Germany