Metastatic Breast Cancer, Locally Recurrent Breast Cancer
Conditions
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.
Interventions
DRUGEribulin
Eribulin alone
DRUGBalixafortide
Balixafortide + Eribulin
Sponsors
Spexis AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (2nd Line+ Population) | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (3rd Line+ Population) | 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). | 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. |
Countries
Argentina, Belgium, Brazil, Czechia, France, Italy, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balixafortide + Eribulin Balixafortide: Balixafortide + Eribulin | 219 |
| Eribulin Monotherapy Eribulin: Eribulin alone | 213 |
| Total | 432 |
Baseline characteristics
| Characteristic | Balixafortide + Eribulin | Eribulin Monotherapy | Total |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.87 | 55.6 years STANDARD_DEVIATION 11.07 | 55.0 years STANDARD_DEVIATION 10.97 |
| Breast Cancer History Time since diagnosis of locally recurrent or metastatic disease | 2.96 years STANDARD_DEVIATION 2.503 | 3.15 years STANDARD_DEVIATION 2.427 | 3.05 years STANDARD_DEVIATION 2.464 |
| Breast Cancer History Time since first diagnosis of breast cancer | 6.99 years STANDARD_DEVIATION 6.096 | 7.21 years STANDARD_DEVIATION 5.647 | 7.10 years STANDARD_DEVIATION 5.873 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 19 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) White | 197 Participants | 174 Participants | 371 Participants |
| Sex: Female, Male Female | 218 Participants | 211 Participants | 429 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 218 | 13 / 204 |
| other Total, other adverse events | 214 / 218 | 197 / 204 |
| serious Total, serious adverse events | 62 / 218 | 54 / 204 |
Outcome results
Primary
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).
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.
Population: Overall Population (2nd Line+)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Balixafortide + Eribulin | Progression Free Survival (2nd Line+ Population) | 3.5 months |
| Eribulin Monotherapy | Progression Free Survival (2nd Line+ Population) | 4.0 months |
p-value: 0.44596% CI: [0.85, 1.41]t-test, 2 sided
Primary
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).
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.
Population: 3rd Line+ Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Balixafortide + Eribulin | Progression Free Survival (3rd Line+ Population) | 3.5 months |
| Eribulin Monotherapy | Progression Free Survival (3rd Line+ Population) | 4.0 months |
p-value: 0.615896% CI: [0.81, 1.41]t-test, 2 sided
Secondary
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.
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).
Population: 3rd Line+ Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Balixafortide + Eribulin | Overall Survival (3rd Line+ Population) | 11.0 months |
| Eribulin Monotherapy | Overall Survival (3rd Line+ Population) | 11.2 months |
p-value: 0.612699.9% CI: [0.66, 1.77]t-test, 2 sided