A Phase 2 interventional study of Eribulin and Trastuzumab in Metastatic Breast Cancer, sponsored by SCRI Development Innovations, LLC. Completed at 18 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-15.
Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment
The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.
This is a non-randomized, open-label trial to evaluate 6 cycles of eribulin in female patients with invasive breast cancer who do not achieve pathologic complete response (pCR) after treatment with a standard neoadjuvant chemotherapy and surgery regimen. Patients will be randomized into three cohorts according to tumor-type: triple-negative (Cohort A), hormone-receptor-positive/HER2-negative (Cohort B), and HER2-positive (Cohort C) tumors. Patients will receive eribulin for 6 cycles (1 cycle = 21 days). Patients with HER2-positive tumors will also receive trastuzumab. Patients in all cohorts will be allowed to receive locoregional radiotherapy and/or adjuvant hormonal therapy per institutional guidelines.
81 studies on the registry are indexed under Pathologic Complete Response; 42 are open to participants now.
This study's enrollment of 127 is above the median of 75 across 62 interventional studies indexed under Pathologic Complete Response.
Browse Pathologic Complete Response studies →SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
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Eribulin 1.4 mg/m\^2 intravenously (IV)
Drug: Eribulin
Eribulin 1.4 mg/m\^2 intravenously (IV)
Drug: Eribulin
Eribulin 1.4 mg/m\^2 intravenously (IV) Trastuzumab 6mg/kg intravenously (IV)
Drug: Eribulin · Drug: Trastuzumab
1.4 mg/m\^2 IV Days 1 and 8, every 21 days for six cycles
Also known as: Halaven
6 mg/kg IV Day 1 every 21 days
Also known as: Herceptin
Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy
The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 2 years
Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility
Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.
Time frame: up to 18 weeks
The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety
A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
Time frame: Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment. After that patients were followed every 3 months for up to 2 years.
Between September 2011 to April 2015, 127 female patients who did not achieve a pathologic complete response (pCR i.e. have residual invasive disease in breast or lymph node tissue) after treatment with a standard neoadjuvant chemotherapy regimen and surgery were enrolled. Of those 127 patients enrolled, 126 patients received treatment.
| Milestone | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2-positive Breast Cancer Patients |
|---|---|---|---|
| Started | 54 | 42 | 31 |
| Completed | 53 | 42 | 31 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2-positive Breast Cancer Patients |
|---|---|---|---|
| Started | 53 | 42 | 31 |
| Completed | 46 | 34 | 26 |
| Not completed | 7 | 8 | 5 |
| Withdrew: Disease progression | 2 | 2 | 1 |
| Withdrew: Adverse event | 4 | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 | 2 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| percentage of patients | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients | Cohort C: HER2-positive Breast Cancer Patients |
|---|---|---|---|
| Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy | 56 (42 to 69) | 83 (67 to 91) | 73 (53 to 86) |
Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.
| Participants | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2-positive Breast Cancer Patients |
|---|---|---|---|
| Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility | 46 | 34 | 26 |
A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
| Participants | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2-positive Breast Cancer Patients |
|---|---|---|---|
| The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety | 50 | 41 | 31 |
Collected over Day 1 and Day 8 of every treatment cycle and 30 days after discontinuation or completion of treatment for up to 22.2 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Triple-negative Breast Cancer | 6/53 (11.3%) | 8/53 (15.1%) | 52/52 (100%) |
| Cohort B: ER/PR Positive/HER2-negative Breast Cancer | 4/42 (9.5%) | 1/42 (2.4%) | 42/42 (100%) |
| Cohort C: HER2 Positive Breast Cancer | 1/31 (3.2%) | 3/31 (9.7%) | 31/31 (100%) |
| Event | Cohort A: Triple-negative Breast Cancer | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2 Positive Breast Cancer |
|---|---|---|---|
| CellulitisInfections and infestations | 0/53 | 0/42 | 1/31 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 0/53 | 0/42 | 1/31 |
| SinusitisInfections and infestations | 0/53 | 0/42 | 1/31 |
| TracheobronchitisInfections and infestations | 0/53 | 1/42 | 0/31 |
| Cardiac failure congestiveCardiac disorders | 1/53 | 0/42 | 0/31 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/53 | 0/42 | 0/31 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/53 | 0/42 | 0/31 |
| MastitisInfections and infestations | 1/53 | 0/42 | 0/31 |
| MetastasisNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/53 | 0/42 | 0/31 |
| PneumoniaInfections and infestations | 1/53 | 0/42 | 0/31 |
| Event | Cohort A: Triple-negative Breast Cancer | Cohort B: ER/PR Positive/HER2-negative Breast Cancer | Cohort C: HER2 Positive Breast Cancer |
|---|---|---|---|
| FatigueGeneral disorders | 33/52 | 26/42 | 23/31 |
| Peripheral Sensory NeuropathyNervous system disorders | 24/52 | 25/42 | 16/31 |
| Neutrophil Count DecreasedInvestigations | 26/52 | 21/42 | 17/31 |
| LeukopeniaInvestigations | 15/52 | 23/42 | 12/31 |
| AnemiaBlood and lymphatic system disorders | 20/52 | 13/42 | 16/31 |
| NauseaGastrointestinal disorders | 18/52 | 16/42 | 14/31 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 20/52 | 8/42 | 12/31 |
| ConstipationGastrointestinal disorders | 14/52 | 13/42 | 9/31 |
| MyalgiaMusculoskeletal and connective tissue disorders | 13/52 | 9/42 | 9/31 |
| HeadacheNervous system disorders | 11/52 | 12/42 | 5/31 |
All patients who receive at least one dose of treatment.
| Age, Continuous(years) | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients | Cohort C: HER2-positive Breast Cancer Patients | Total |
|---|---|---|---|---|
| Median | 49 (28 to 74) | 55 (27 to 71) | 52 (38 to 78) | 52 (27 to 78) |
| Sex: Female, Male(Participants) | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients | Cohort C: HER2-positive Breast Cancer Patients | Total |
|---|---|---|---|---|
| Female | 53 | 42 | 31 | 126 |
| Male | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients | Cohort C: HER2-positive Breast Cancer Patients | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 12 | 4 | 2 | 18 |
| White | 39 | 37 | 28 | 104 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 1 | 4 |
| Region of Enrollment(Participants) | Cohort A: Triple-negative Breast Cancer Patients | Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients | Cohort C: HER2-positive Breast Cancer Patients | Total |
|---|---|---|---|---|
| United States | 53 | 42 | 31 | 126 |
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