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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. Read our disclaimer for details. Identifier: NCT03786094
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : November 30, 2020
Information provided by (Responsible Party):
Polyphor Ltd.

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date November 30, 2020
Actual Study Start Date  ICMJE June 14, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
Progression Free Survival as assessed by Independent Review Committee [ Time Frame: 12 months after last patient randomized ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Locally Recurrent Breast Cancer
Intervention  ICMJE
  • Drug: Eribulin
    Eribulin alone
    Other Name: Eribulin Injection [Halaven]
  • Drug: Balixafortide
    balixafortide + eribulin
    Other Name: POL6326
Study Arms  ICMJE
  • Active Comparator: Eribulin
    Intervention: Drug: Eribulin
  • Experimental: Balixafortide + eribulin
    • Drug: Eribulin
    • Drug: Balixafortide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Czechia,   France,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Germany
Administrative Information
NCT Number  ICMJE NCT03786094
Other Study ID Numbers  ICMJE POL6326-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Polyphor Ltd.
Study Sponsor  ICMJE Polyphor Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Polyphor Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP