A Phase 2 interventional study of Eribulin in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
Improvements in outcomes with metastatic breast cancer (MBC) have been observed in the last 30 years, however, overall prognosis remains poor with median survival of 2 to 3 years. Long term complete responses are observed only for a minority of MBC patients (2-5%) and MBC remains an incurable disease for most patients. Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with MBC who have received at least two prior chemotherapy regimens. In this research study, the investigators are looking to see how well eribulin helps participants with MBC in an earlier-line setting. Eribulin works by interfering with cancer cell division, growth and spread.
Based on positive results in heavily pre-treated MBC patients, eribulin is being studied as first-line or second-line chemotherapy treatment. This is a non-randomized, open label study with participants enrolled in one of two cohorts: Cohort 1. Hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) or Cohort 2: Triple negative breast cancer (TNBC) meaning HR-negative/HER2-negative (HR-/HER2-). HR- means progesterone receptor-negative (PR-) and estrogen receptor-negative (ER-). Beyond efficacy as measured primarily by response to treatment, investigators will evaluate safety, tolerability and quality of life. In particular, it is hypothesized that eribulin may have lower rates of neuropathy, a common side effect of many of the major chemotherapeutics with activity in MBC. The investigators will study the effect eribulin has on the nerves through regular questionnaires that ask about any nerve-related symptoms. The investigators also plan to send blood samples to explore if gene markers may indicate increased sensitivity to the nerve effects of eribulin.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 83 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.
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Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.
Drug: Eribulin
Eribulin: 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of each 21 day cycle Participants remained on single agent eribulin until disease progression or withdrawal for other reasons.
Drug: Eribulin
Also known as: E7389, Halaven, ER-086526, NSC-707389
Overall Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
Progression-Free Survival (PFS)
PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) PFS follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.
Time to First Response (TTR)
TTR is defined as the time from first dose of study treatment until the earliest date that complete response (CR) or partial response (PR) based on RECIST 1.1 criteria is objectively documented. Non-CR, non-PR participants are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response requires 4 week or later confirmation and assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).
Duration of Overall Response (DOR)
DOR is defined as the that response criteria for CR or PR (whichever is recorded first) are first met until the date that PD or death from any cause is first objectively documented. Participants who do not have PD will be censored on date of last disease assessment.
Time frame: Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) DOR follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.
Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Sensory Neuropathy
The percentage of treated participants experiencing grade 1-3 peripheral sensory neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
Time frame: Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Motor Neuropathy
TThe percentage of treated participants experiencing grade 1-3 peripheral motor neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
Time frame: Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)
Functional Assessment of Cancer Therapy-Breast Cancer Subscale (FACT-BCS) Change Score From Baseline
The FACT-BCS is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to breast cancer patients. (Brady MJ, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. JCO 1997; 15:974-86). The FACT-BCS has 9-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 36. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
Time frame: Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11
Functional Assessment of Cancer Therapy-Neurotoxicity Subscale (FACT-Ntx) Change Score From Baseline
The FACT-Ntx is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to patients suffering from neurotoxicity. (Calhoun EA, et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 2003; 13:741-8). The FACT-Ntx has 11-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 44. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
Time frame: Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11
Participants were enrolled between May 2013 and March 2016.
| Milestone | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Started | 45 | 38 |
| Completed | 45 | 38 |
| Not completed | 0 | 0 |
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| percentage of participants | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Overall Response Rate (ORR) | 35.6 (24 to 49) | 13.2 (5 to 26) |
PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
| months | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Progression-Free Survival (PFS) | 6.2 (5.9 to 8.7) | 4.0 (3.5 to 4.8) |
TTR is defined as the time from first dose of study treatment until the earliest date that complete response (CR) or partial response (PR) based on RECIST 1.1 criteria is objectively documented. Non-CR, non-PR participants are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response requires 4 week or later confirmation and assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| months | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Time to First Response (TTR) | 10.6 (1.7 to 14.9) | NA (1.9 to 4.3) |
DOR is defined as the that response criteria for CR or PR (whichever is recorded first) are first met until the date that PD or death from any cause is first objectively documented. Participants who do not have PD will be censored on date of last disease assessment.
| months | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Duration of Overall Response (DOR) | 6.5 (1.8 to 12.3) | 1.9 (1.3 to 4.1) |
The percentage of treated participants experiencing grade 1-3 peripheral sensory neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
| percentage of participants | Combined Cohort 1: HR+/HER2- and Cohort 2: TNBC |
|---|---|
| Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Sensory Neuropathy | 36.1 (27.4 to 45.7) |
TThe percentage of treated participants experiencing grade 1-3 peripheral motor neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.
| percentage of participants | Combined Cohort 1: HR+/HER2- and Cohort 2: TNBC |
|---|---|
| Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Motor Neuropathy | 22.9 (15.5 to 31.7) |
The FACT-BCS is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to breast cancer patients. (Brady MJ, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. JCO 1997; 15:974-86). The FACT-BCS has 9-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 36. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
| units on a scale | Combined Group (Hormone Receptor Positive and Triple Negative) |
|---|---|
| Cycle 2 Change from Baseline | 1.0 ± 4.6 |
| Cycle 3 Change from Baseline | 0.6 ± 5.1 |
| Cycle 5 Change from Baseline | 0.1 ± 4.4 |
| Cycle 7 Change from Baseline | 0.6 ± 3.2 |
| Cycle 9 Change from Baseline | 1.8 ± 5.0 |
| Cycle 11 Change from Baseline | 1.1 ± 2.9 |
The FACT-Ntx is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to patients suffering from neurotoxicity. (Calhoun EA, et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 2003; 13:741-8). The FACT-Ntx has 11-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 44. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.
| units on a scale | Combine Cohort 1: HR+/HER2- and Cohort 2: TNBC |
|---|---|
| Cycle 2 Change from Baseline | -0.1 ± 3.0 |
| Cycle 3 Change from Baseline | -0.3 ± 4.7 |
| Cycle 5 Change from Baseline | -1.6 ± 5.5 |
| Cycle 7 Change from Baseline | -4.5 ± 6.4 |
| Cycle 9 Change from Baseline | -1.8 ± 5.9 |
| Cycle 11 Change from Baseline | -1.6 ± 4.7 |
OS based on Kaplan-Meier is defined as the time from study entry to death or censored at date last known alive.
| months | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Overall Survival | 20 (20 to NA) | 11.3 (9.1 to NA) |
Collected over Adverse events (AEs) were assessed every cycle on treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: HR+/HER2- | 4/45 (8.9%) | 22/45 (48.9%) | 45/45 (100%) |
| Cohort 2: TNBC | 9/38 (23.7%) | 13/38 (34.2%) | 37/38 (97.4%) |
| Event | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| Neutrophil count decreasedInvestigations | 16/45 | 4/38 |
| Peripheral motor neuropathyNervous system disorders | 3/45 | 0/38 |
| AnemiaBlood and lymphatic system disorders | 0/45 | 2/38 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/45 | 2/38 |
| Peripheral sensory neuropathyNervous system disorders | 2/45 | 2/38 |
| VomitingGastrointestinal disorders | 1/45 | 2/38 |
| AlopeciaSkin and subcutaneous tissue disorders | 2/45 | 0/38 |
| White blood cell decreasedInvestigations | 2/45 | 1/38 |
| DiarrheaGastrointestinal disorders | 1/45 | 1/38 |
| Lip infectionInfections and infestations | 0/45 | 1/38 |
| Event | Cohort 1: HR+/HER2- | Cohort 2: TNBC |
|---|---|---|
| FatigueGeneral disorders | 29/45 | 25/38 |
| AlopeciaSkin and subcutaneous tissue disorders | 26/45 | 15/38 |
| NauseaGastrointestinal disorders | 17/45 | 17/38 |
| Peripheral sensory neuropathyNervous system disorders | 17/45 | 9/38 |
| ConstipationGastrointestinal disorders | 9/45 | 12/38 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 14/45 | 5/38 |
| Mucositis oralGastrointestinal disorders | 12/45 | 5/38 |
| PainGeneral disorders | 12/45 | 6/38 |
| Peripheral motor neuropathyNervous system disorders | 12/45 | 5/38 |
| AnorexiaMetabolism and nutrition disorders | 11/45 | 6/38 |
| Age, Categorical(Participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 33 | 68 |
| >=65 years | 10 | 5 | 15 |
| Age, Continuous(years) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| Median | 59 (34 to 87) | 53 (38 to 76) | 56 (34 to 87) |
| Sex: Female, Male(Participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| Female | 45 | 38 | 83 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 35 | 76 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 42 | 34 | 76 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| United States | 45 | 38 | 83 |
| Eastern Cooperative Oncology Group Performance Score (ECOG PS)(Participants) | Cohort 1: HR+/HER2- | Cohort 2: TNBC | Total |
|---|---|---|---|
| ECOG PS0 | 33 | 26 | 59 |
| ECOG PS1 | 11 | 12 | 23 |
| ECOG PS2 | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from May 2013 to primary completion in May 2016, 36 months.
Results were first posted in Feb 2019, 2 years 9 months after primary completion.
Of 983 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 85. This study's 36 months is below that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eribulin
Dana-Farber Cancer Institute →