Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments eribulin mesylate, trastuzumab
Phase phase 2
Target HER2
Sponsor SCRI Development Innovations, LLC
Collaborator Eisai Inc.
Start date September 2011
End date April 2017
Trial size 128 participants
Trial identifier NCT01401959, SCRI BRE 186

Summary

The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who do not achieve pCR following standard neoadjuvant chemotherapy. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
eribulin mesylate
eribulin mesylate Halaven
1.4 mg/m2 IV Days 1 and 8, every 21 days
(Experimental)
eribulin mesylate trastuzumab
eribulin mesylate Halaven
1.4 mg/m2 IV Days 1 and 8, every 21 days
trastuzumab Herceptin
6 mg/kg IV Day 1 every 21 days
(Experimental)
eribulin mesylate
eribulin mesylate Halaven
1.4 mg/m2 IV Days 1 and 8, every 21 days

Primary Outcomes

Measure
Two-Year Disease-Free Survival (DFS)
time frame: 2 years after completion of treatment

Secondary Outcomes

Measure
Number of patients who complete all protocol-specified therapy without undue toxicity leading to early discontinuation or evidence of disease recurrence.
time frame: 2 years
Number of adverse events and serious adverse events as a measure of safety.
time frame: up to 2 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Female patients >=18 years-of-age. 2. Histologically confirmed breast cancer prior to surgery with the following staging criteria: T1-T3, N0-N2, and M0 (T1N0M0 patients are excluded). 3. Previous treatment with a minimum of 4 cycles of neoadjuvant anthracycline and/or taxane containing chemotherapy (+trastuzumab in HER2-positive patients). 4. 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. 5. 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, N1-N3a, M0 or ypT1b-T4, N0-N3a, M0]. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 7. Recovery from any toxic effects of prior therapy to <=Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) except fatigue or alopecia. 8. Peripheral neuropathy Grade <=2 per NCI CTCAE v4.03 at trial entry. 9. Normal left ventricular ejection fraction (LVEF), within the institutional limits of normal, as measured by echocardiography (ECHO) or multi-gated (MUGA) scan in patients to receive trastuzumab with eribulin (Cohort C). 10. Adequate hematologic, hepatic, and renal function 11. Complete staging work-up to confirm localized disease should include computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan. (Note: a PET/CT is acceptable for baseline imaging in lieu of CT examinations or bone scan). Negative scans performed prior to the initiation of neoadjuvant therapy, or at any subsequent time, are acceptable and do not need to be repeated. 12. Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum pregnancy test performed within 7 days prior to start of trial treatment. 13. Willingness and ability to comply with trial and follow-up procedures. 14. Ability to understand the investigative nature of this trial and give written informed consent. 15. Agree to delay in reconstruction in terms of implants placed in setting of expanders until chemotherapy is completed and the patient has recovered. Expansion of expanders may continue during trial treatment. Exclusion Criteria: 1. Presence of other active cancers, or history of treatment for invasive cancer <3 years prior to trial entry (except thyroid, cervical cancer). Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer. 2. Radiotherapy prior to the start of study treatment. 3. History or clinical evidence of central nervous system metastases or other metastatic disease. 4. Non-healed surgical wound. 5. Known or suspected allergy/hypersensitivity to eribulin. 6. Cardiac disease, including: congestive heart failure Class II-IV per New York Heart Association classification;cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months. 7. Chronic use of drugs that cause QTc prolongation.Patients must discontinue use of these drugs 7 days prior to the start of study treatment. 8. Women who are pregnant or lactating. All females of child-bearing potential must have negative serum or urine pregnancy tests within 48 hours prior to trial treatment. 9. Patients with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection. 10. Prolongation of heart rate-corrected QT interval (QTc) >480 msecs (using Bazett's formula). 11. 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. 12. 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. 13. Patients may not receive any other investigational or anti-cancer treatments while participating in this trial. 14. 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. 15. Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.

Additional Information

Official title Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
Description 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 regimen and surgery. 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; and patients in Cohort B will receive locoregional radiotherapy and/or adjuvant hormonal therapy per institutional guidelines. Up to 148 patients are planned for enrollment.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by SCRI Development Innovations, LLC.