Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Disease Attributes

Eribulin

Balixafortide

François Ringeisen, MD

Peter A Kaufman, MD

Javier Cortes, MD

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.

Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.

PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.

Spexis AG

For the purposes of the clinical study report, a treatment-emergent adverse event (TEAE) was considered to have occurred at a similar rate between treatment arms if the percentage difference between arms was \<5.0%. TEAEs were defined as AEs that occurred at or after administration of the first dose of any study treatment and through 30 days after the last dose of any study treatment.

Balixafortide + Eribulin

Eribulin Monotherapy

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Time since first diagnosis of breast cancer

Time since diagnosis of locally recurrent or metastatic disease

Breast Cancer History

The trial was halted early due to failure to meet the primary endpoint.

Christian Zwingelstein

Progression Free Survival (2nd Line+ Population)

Progression Free Survival (3rd Line+ Population)

Overall Survival (3rd Line+ Population)

Balixafortide: Balixafortide + Eribulin

Balixafortide was administered as a single IV administration (5.5 mg/kg over at least 2 hours \[±10 minutes\]) on Days 1-3 and Days 8-10 of each 21-day cycle. Eribulin was administered IV at a dose of 1.4 mg/m2 over 2 to 5 minutes on Days 2 and 9 of each 21-day cycle.

Eribulin was administered as a single IV administration (1.4 mg/m2 over 2-5 minutes) on Days 2 and 9 of each 21-day cycle.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer	NCT03786094	Metastatic Brea... Locally Recurre...	Eribulin Balixafortide	18 Years -	Spexis AG
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer	NCT03786094	Metastatic Brea... Locally Recurre...	Eribulin Balixafortide	18 Years -	Spexis AG

Spots Global Cancer Trial Database for balixafortide