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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786094
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Locally Recurrent Breast Cancer Drug: Eribulin Drug: Balixafortide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Eribulin Drug: Eribulin
Eribulin alone
Other Name: Eribulin Injection [Halaven]
Experimental: Balixafortide + eribulin Drug: Eribulin
Eribulin alone
Other Name: Eribulin Injection [Halaven]

Drug: Balixafortide
balixafortide + eribulin
Other Name: POL6326


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival as assessed by Independent Review Committee [ Time Frame: 12 months after last patient randomized ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786094


Contacts
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Contact: Polyphor Ltd +41615671600 info@polyphor.com

Locations
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Sponsors and Collaborators
Polyphor Ltd.
Investigators
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Study Director: François Ringeisen, MD Polyphor Ltd.
Principal Investigator: Peter A Kaufman, MD UVM medical center; USA
Principal Investigator: Javier Cortes, MD IOB and VHIO; Spain
More Information
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Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT03786094    
Other Study ID Numbers: POL6326-009
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases