Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer (FORTRESS)
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ClinicalTrials.gov Identifier: NCT03786094 |
Recruitment Status :
Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : November 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer Locally Recurrent Breast Cancer | Drug: Eribulin Drug: Balixafortide | Phase 3 |
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 |

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 |
- Progression Free Survival as assessed by Independent Review Committee [ Time Frame: 12 months after last patient randomized ]

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

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

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 |
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: | November 30, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |