Phase 2
N=127
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01401959 ↗Enrolled (actual)
127
Serious AEs
9.5%
Results posted
May 2018
Primary outcome: Primary: Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy — 56; 83; 73 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eribulin (Drug); Trastuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy |
56; 83; 73 | — |
| SECONDARY Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility |
46; 34; 26 | — |
| SECONDARY The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety |
50; 41; 31 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female patients >=18 years-of-age.
- Histologically confirmed breast cancer prior to surgery with the following staging criteria: T1-T3, T4a, T4b, N0-N2, N3a and M0 (T1N0M0 patients are excluded). Inflammatory disease is excluded.
- Previous treatment with a minimum of 4 cycles of neoadjuvant anthracycline and/or taxane containing chemotherapy (+trastuzumab in HER2-positive patients).
- Patients must be ≥ 21 days and ≤ 84 days from breast surgery and fully recovered. Patients may have had mastectomy or breast conservation surgery with axillary node dissection.
- Pathologic CR (pCR) not achieved following neoadjuvant treatment (i.e., residual invasive breast cancer (>5 mm) in the breast or presence of nodal disease at surgery [ypT0/T1a, N1-N3a, M0 or ypT1b-T4, N0-N3a, M0].
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Recovery from any toxic effects of prior therapy to 480 msecs (using Bazett's formula).
- Minor surgical procedures (with the exception of the placement of port-a-cath or other central venous access) performed less than 7 days prior to beginning protocol treatment.
- History of cerebrovascular accident including transient ischemic attack (TIA), or untreated deep venous thrombosis (DVT)/ pulmonary embolism (PE) within the past 6 months. Note: Patients with recent DVT/PE receiving treatment with a stable dose of therapeutic anti-coagulating agents are eligible.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the trial participation or investigational product(s) administration or may interfere with the interpretation of the results.
- Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.
Data sourced from ClinicalTrials.gov (NCT01401959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.