Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial.

Pernas S, Martin M, Kaufman PA, Gil-Martin M, Gomez Pardo P, Lopez-Tarruella S, Manso L, Ciruelos E, Perez-Fidalgo JA, Hernando C, Ademuyiwa FO, Weilbaecher K and 10 more

Show all authors

Mayer I, Pluard TJ, Martinez Garcia M, Vahdat L, Perez-Garcia J, Wach A, Barker D, Fung S, Romagnoli B, Cortes J

The Lancet. Oncology26 Apr 2018Cited by 116 (Europe PMC)

PMID29706375DOI10.1016/s1470-2045(18)30147-5PepBankPUB-29706375

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study18

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone18

In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Balixafortide.

01HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, no dose-limiting toxicities were confirmed with balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, no dose-limiting toxicities were confirmed with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableDose-limiting toxicity
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
No dose-limiting toxicities were confirmed and the maximum tolerated dose was not reached.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637503
02HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, the maximum tolerated dose of balixafortide plus eribulin was not reached.
In plain wordsIn patients with metastatic breast cancer, the combination did not reach a maximum tolerated dose.
Peptide
Balixafortide
Outcome
Not applicableMaximum tolerated dose
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
No dose-limiting toxicities were confirmed and the maximum tolerated dose was not reached.
3 context sentences(design, population, supporting numbers)
Summary · context
The highest dose was established as eribulin 1·4 mg/m² on days 2 and 9, and balixafortide 5·5 mg/kg on days 1-3 and 8-10 of the 21-day cycle.
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637504
03HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, fatigue occurred in 44 of 56 patients (79%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 79% had fatigue with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableFatigue
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with fatigue
44 patients
56 patients, treatment-emergent, any grade
Fatigue incidence
79%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637506
04HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, neutropenia occurred in 32 patients (57%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 57% had neutropenia with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableNeutropenia
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with neutropenia
32 patients
56 patients, treatment-emergent, any grade
Neutropenia incidence
57%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637507
05HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, infusion-related reactions occurred in 27 patients (48%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 48% had infusion reactions with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableInfusion-related reactions
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with infusion-related reactions
27 patients
56 patients, treatment-emergent, any grade
Infusion-related reactions incidence
48%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637508
06HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, alopecia occurred in 26 patients (46%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 46% had hair loss with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableAlopecia
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with alopecia
26 patients
56 patients, treatment-emergent, any grade
Alopecia incidence
46%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637509
07HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, constipation occurred in 26 patients (46%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 46% had constipation with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableConstipation
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with constipation
26 patients
56 patients, treatment-emergent, any grade
Constipation incidence
46%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637510
08HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, nausea occurred in 25 patients (45%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 45% had nausea with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableNausea
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with nausea
25 patients
56 patients, treatment-emergent, any grade
Nausea incidence
45%
56 patients, treatment-emergent, any grade
Source sentences
Summary
The most common treatment-emergent adverse events of any grade were fatigue (44 [79%] of 56 patients), neutropenia (32 [57%]), infusion-related reactions (27 [48%]), alopecia (26 [46%]), constipation (26 [46%]), and nausea (25 [45%]).
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637511
09HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious adverse events occurred in 21 of 56 patients (38%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 38% had serious adverse events with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious adverse events
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious adverse events
21 patients
56 patients, serious adverse events
Serious adverse events incidence
38%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637512
10HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious febrile neutropenia occurred in five patients (9%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 9% had serious febrile neutropenia with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious febrile neutropenia
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious febrile neutropenia
5 patients
56 patients, serious adverse events
Serious febrile neutropenia incidence
9%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637513
11HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious neutrophil count decrease occurred in two patients (4%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 4% had serious neutrophil count decreases with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious neutrophil count decrease
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious neutrophil count decrease
2 patients
56 patients, serious adverse events
Serious neutrophil count decrease incidence
4%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637514
12HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious constipation occurred in two patients (4%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 4% had serious constipation with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious constipation
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious constipation
2 patients
56 patients, serious adverse events
Serious constipation incidence
4%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637515
13HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious pneumonia occurred in two patients (4%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 4% had serious pneumonia with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious pneumonia
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious pneumonia
2 patients
56 patients, serious adverse events
Serious pneumonia incidence
4%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637516
14HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, serious urinary tract infection occurred in three patients (5%) receiving balixafortide plus eribulin.
In plain wordsIn patients with metastatic breast cancer, 5% had serious urinary infections with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableSerious urinary tract infection
Study
n = 56
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Patients with serious urinary tract infection
3 patients
56 patients, serious adverse events
Serious urinary tract infection incidence
5%
56 patients, serious adverse events
Source sentences
Summary
Serious adverse events occurred in 21 (38%) of 56 patients, including febrile neutropenia in five (9%) of 56 patients, neutrophil count decrease in two (4%) patients, constipation in two (4%) patients, pneumonia in two (4%) patients, and urinary tract infection in three (5%) patients.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637517
15HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, a treatment-related fatal adverse event occurred in the first balixafortide-eribulin cohort.
In plain wordsIn patients with metastatic breast cancer, a treatment-related fatal event occurred with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableTreatment-related fatal adverse event
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Source sentences
Summary
After a treatment-related fatal adverse event in the first cohort who received 21-day cycles of treatment with eribulin and balixafortide, a protocol amendment modified the study design to be done in two parts.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637501
16HumanNot a test of Balixafortide aloneNon-randomized trialPharmacokinetics
In metastatic breast cancer, the part 1 evaluation did not confirm eribulin-balixafortide interactions.
In plain wordsIn patients with metastatic breast cancer, the initial evaluation did not confirm interactions between eribulin and balixafortide.
Peptide
Balixafortide
Outcome
No significant changeDrug interaction
Study
n: not reported in source
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
The evaluation of part 1 did not confirm any dose-limiting toxicities or eribulin-balixafortide interactions,
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637502
17HumanNot a test of Balixafortide aloneNon-randomized trialSafety outcome
In metastatic breast cancer, two of 56 patients (4%) died during balixafortide-eribulin treatment, from septic shock and pneumonia.
In plain wordsIn patients with metastatic breast cancer, two died during balixafortide-eribulin treatment, from septic shock and pneumonia.
Peptide
Balixafortide
Outcome
Not applicableDeaths during treatment
Study
n = 56
Outcome group
Mortality · Whole body
Measurements
Deaths
2 patients
56 patients receiving study treatment
Death rate
4%
during study treatment
Source sentences
Summary
Two (4%) of 56 patients died while receiving study treatment; one from septic shock and one from pneumonia.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637518
18HumanNot a test of Balixafortide aloneNon-randomized trialEfficacy outcome
In metastatic breast cancer, balixafortide plus eribulin produced partial responses in 16 of 54 evaluable patients (30%, 95% CI 18-44).
In plain wordsIn patients with metastatic breast cancer, 30% had partial responses with balixafortide plus eribulin.
Peptide
Balixafortide
Outcome
Not applicableObjective response
Study
n = 54
Outcome group
Tumor growth · Cancer
Measurements
Partial responses
16 patients
54 evaluable patients
Objective response rate
30%
95% CI 18-44
Source sentences
Summary
Objective responses (all partial responses) were observed in 16 (30%; 95% CI 18-44) of 54 patients who were evaluable for antitumour activity.
2 context sentences(design, population, supporting numbers)
Summary · context
We assessed the safety, tolerability, pharmacokinetics, and preliminary phase 1 activity of the CXCR4 antagonist, balixafortide, in combination with eribulin chemotherapy in patients with heavily pretreated, relapsed metastatic breast cancer.
Summary · context
This single-arm, dose-escalation, phase 1 trial enrolled patients at 11 sites in Spain and the USA.
In this study, Balixafortide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Balixafortide.
Report a problemFND-2970637505

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01837095

Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer

Polyphor Ltd.n = 54Jun 2013 to Aug 2018

Metastatic Breast Cancer

Trial page ClinicalTrials.govUpdated 14 Sept 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

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