Metastatic Breast CancerPhase 3FORTRESSNCT03786094
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
A Phase 3 study testing Eribulin and Balixafortide in people with Metastatic Breast Cancer and Locally Recurrent Breast Cancer, run by Spexis AG at 88 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Recurrent Breast Cancer
- What is being tested?
- Eribulin and Balixafortide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 88 sitesin 13 countries
- Study dates
- 30 May 2019to 19 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
88 sites in 13 countries.
88 sites in 13 countries
United States28 sites
University Cancer and Blood Center, LLC
Athens, Georgia, 30607
Piedmont Cancer Institute PC
Atlanta, Georgia, 30318
University of Vermont Medical Center
Burlington, Vermont, 05401
Florida Cancer Specialists SOUTH - SCRI - PPDS
Fort Myers, Florida, 33901
California Cancer Associates for Research and Excellence
Fresno, California, 93720
CHI Health St. Francis
Grand Island, Nebraska, 68803
Saint Luke's Cancer Institute 150 Entrance
Kansas City, Missouri, 63376
HCA Midwest Health - SCRI - PPDS
Kansas City, Missouri, 64132
Herbert-Herman Cancer Center, Sparrow Hospital
Lansing, Michigan, 48912
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
West Virginia University Hospital
Morgantown, West Virginia, 26506
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Queens Hospital Cancer Center
New York, New York, 11432
Norwalk Hospital
Norwalk, Connecticut, 06856
Orlando Health
Orlando, Florida, 32806
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, 97210
UCSF Mount Zion Cancer Center
San Francisco, California, 94115
Stanford Cancer Center South Bay
San Jose, California, 95124
Orchard Healthcare Research Inc
Skokie, Illinois, 60077
Mercy Research Oncology
St Louis, Missouri, 63141
Florida Cancer Specialists NORTH - SCRI - PPDS
St. Petersburg, Florida, 33705
Florida Cancer Specialists PAN - SCRI - PPDS
Tallahassee, Florida, 32308
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308
Vanderbilt University Medical Center
Tennessee City, Tennessee, 37204
Florida Cancer Specialists EAST - SCRI - PPDS
West Palm Beach, Florida, 33401
Spain12 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Universitario de Badajoz
Badajoz, 06006
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Quironsalud Barcelona
Barcelona, Catalonia, 8023
Hospital Universitario Vall D'Hebrón
Barcelona, 08035
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Ruber Internacional
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Russia8 sites
LLC Evimed
Chelyabinsk, 454048
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk, 191024
Medical Center Tonus
Nizhny Novgorod, 603089
Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"
Omsk, 644013
Evromedservis LCC
Pushkin, 196603
Mordovia State University
Saransk, 430000
Research Oncology Institute of Tomsk Scientific Center
Tomsk, 634009
Volgograd Regional Clinical Oncology Dispensary
Volgograd, 400138
Brazil7 sites
Centro de Oncologia Da Bahia
Bahia, 41820-021
Universidade de Caxias do Sul (IPCEM-UCS)
Caxias do Sul, 95070-560
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, 81520-060
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, 90610-000
INCA Instituto Nacional De Cancer
Rio de Janeiro, 20560-120
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
São José do Rio Preto, 15090-000
Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda
São Paulo, 01317-001
Belgium5 sites
UZ Antwerpen
Antwerp, 2650
CHIREC Centre Hospitalier Interregional Edith Cavell
Brussels, 1160
Grand Hopital de Charleroi asbl
Charleroi, Hainaut, 6000
UZ Gent
Ghent, 9000
CHU de Liège
Liège, 4000
Italy5 sites
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, 95123
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza, Milano, 20900
Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"
Naples, 80131
Argentina4 sites
Sanatorio Parque de Rosario
Rosario, Santa Fe Province, S2000
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, Buenos Aires, J5402DIL
CAIPO Centro para la atención integral del paciente oncológico
San Miguel de Tucumán, 4000
Centro de Investigación Clínica - Clínica Viedma
Viedma, Río Negro Province, 8500
South Korea4 sites
National Cancer Center
Goyang-si, 10408
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Ulsan University Hospital
Ulsan, 44033
Ukraine4 sites
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS
Dnipro, 49102
LLC Medical Center Family Medicine Clinic
Dnipro, 49600
Municipal Institution SubCarpathian Clinical Oncological Centre
Ivano-Frankivsk, 76018
CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre
Lviv, 79031
Czechia3 sites
Multiscan s.r.o - Onkologická ambulance
Hořovice, 28831
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Fakultni nemocnice v Motole
Prague, 15000
France3 sites
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, 69008
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
EDOG - Institut Claudius Regaud - PPDS
Toulouse, 31100
Taiwan3 sites
Chi Mei Medical Center, Liouying
Tainan, 736
Taipei Veterans General Hospital
Taipei, 11217
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11259
United Kingdom2 sites
Leicester Royal Infirmary
Leicester, LE1 5WW
Barts Cancer Institute
London, EC1A 7BE
About this study
Official title: 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
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.
- Being tested
- Eribulin, Balixafortide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Also called Eribulin Injection [Halaven]
Eribulin alone
BalixafortideDrug
Also called POL6326
Balixafortide + Eribulin
| Study group | Role | What they receive |
|---|---|---|
| Eribulin | Active comparator | Not described Receives: Drug: Eribulin |
| Balixafortide + Eribulin | Experimental | Not described Receives: Drug: Eribulin; Drug: Balixafortide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (2nd Line+ Population)
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).
Measured: 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)
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).
Measured: 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.
Secondary outcomes (1)
Overall Survival (3rd Line+ Population)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start30 May 2019
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Why it stopped: The study was halted early due to failure to meet the primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spexis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Ringeisen, MD, Study director, Polyphor Ltd.Peter A Kaufman, MD, Principal investigator, UVM medical center; USAJavier Cortes, MD, Principal investigator, IOB and VHIO; Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786094
- Sponsor's protocol ID
- POL6326-009
- Acronym
- FORTRESS
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2018
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03786094
- Acronym / sponsor ID
- FORTRESS / POL6326-009
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted early due to failure to meet the primary endpoint.
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Spexis AGIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eribulin | Active comparator | Drug: Eribulin |
| Balixafortide + Eribulin | Experimental | Drug: Eribulin, Drug: Balixafortide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EribulinAlso: Eribulin Injection [Halaven]Eribulin alone | Drug | Balixafortide + Eribulin, Eribulin |
| BalixafortideAlso: POL6326Balixafortide + Eribulin | Drug | Balixafortide + Eribulin |
Primary outcome
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.
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.
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).
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Ringeisen, MD study director
Polyphor Ltd.
Peter A Kaufman, MD principal investigator
UVM medical center; USA
Javier Cortes, MD principal investigator
IOB and VHIO; Spain
88 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eribulin and Balixafortide in people with Metastatic Breast Cancer and Locally Recurrent Breast Cancer, run by Spexis AG at 88 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Spain, Russia, Brazil, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.