Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

Short name FORTRESS

NCTNCT03786094Other idPOL6326-009

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study was halted early due to failure to meet the primary endpoint.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 432 participants (actual)
Sponsor: Spexis AG · Industry
Design: Randomized · Open label (no masking)
Countries: 13 countries
United States, Argentina, Belgium, Brazil, Czechia, France, Italy, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Start: 30 May 2019
Primary completion: 19 Oct 2021
Completion: 19 Oct 2021
First posted: 24 Dec 2018
Last update posted: 1 Nov 2023
Conditions: Metastatic Breast Cancer · Locally Recurrent Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2019202020212022

Ph 3
FORTRESS
NCT03786094
30 May 2019 to 19 Oct 2021
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

EribulinDrug
BalixafortideDrug

Arms2

Active comparator
Eribulin
Experimental
Balixafortide + Eribulin

Primary outcomes2

Outcomes the sponsor listed as primary.

Progression Free Survival (2nd Line+ Population)
Time frame · Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
Registry description
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).
Progression Free Survival (3rd Line+ Population)
Time frame · Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
Registry description
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).

Secondary outcomes(1)

Overall Survival (3rd Line+ Population)
Time frame · The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.

Progression Free Survival (2nd Line+ Population)

Group	Value (months)
Balixafortide + Eribulin	3.5
Eribulin Monotherapy	4.0

Primary outcomeMedian· Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.

Progression Free Survival (3rd Line+ Population)

Group	Value (months)
Balixafortide + Eribulin	3.5
Eribulin Monotherapy	4.0

Secondary and other outcome results(1)

Secondary outcomeMedian· The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).

Overall Survival (3rd Line+ Population)

Group	Value (months)
Balixafortide + Eribulin	11.0
Eribulin Monotherapy	11.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Balixafortide + EribulinBalixafortide: Balixafortide + Eribulin	17 / 218	62 / 218	214 / 218
Eribulin MonotherapyEribulin: Eribulin alone	13 / 204	54 / 204	197 / 204

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Key Inclusion Criteria: * Histologically confirmed Breast cancer * Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer * refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy * At least 14 days from the completion of any previous cancer therapy * Adequate organ function * Life expectancy of 3 months or more * Willing and able to comply with the protocol and able to understand and willing to sign an informed consent Key Exclusion Criteria: * Previously treated with eribulin * Peripheral neuropathy Grade ≥3 * Receipt of prior CXCR4 therapy * Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1 * History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study * Breast feeding or pregnant * Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes

PepBank is a research reference. Talk to a doctor before you use any peptide.