Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer

Paused · Phase 3

Conditions studied: Breast Adenocarcinoma, HER2/Neu Negative, Invasive Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7

In brief

This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back. Drugs used in chemotherapy, such as eribulin mesylate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key facts

Study ID

NCT02037529

Run by

Academic and Community Cancer Research United

People needed

201

Starts

2014-01-17

Expected to finish

2024-10-31

Last updated by the study team

2024-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent document signed and dated by patient
• Histologic confirmation of invasive adenocarcinoma originating in the breast
• Stage IV disease or stage IIIC disease (using the 7th edition American Joint Committee on Cancer [AJCC] criteria) not amenable to local therapy
• Clinical or radiographic evidence of disease progression
• Documentation of HER2 negative breast cancer at the time of protocol registration; (Note: HER2 negativity is defined as 0 or 1+ by immunohistochemistry OR nonamplified or equivocal by fluorescence in situ hybridization [FISH]; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
• Known hormone receptor status at the time of protocol registration; (Note: estrogen receptor [ER] and/or progesterone receptor [PgR] status are considered positive with a cut-off of >= 1% invasive tumor cells; status may be defined on the basis of historic results on the breast primary or a metastatic site, whichever is most recent; repeat biopsies are not required for participation in this protocol)
• Patients must demonstrate resolution of all toxicities related to prior chemotherapy, endocrine therapy, targeted therapy, or biologic therapy to grade =< 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible)
• No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed >= 14 days prior to randomization
• Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen
• Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen
• If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen
• If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen
• If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen
• If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
• Prior treatment may include a taxane as per the following criteria:
• Prior taxane (including paclitaxel) in the adjuvant or neoadjuvant setting is allowed, provided that the interval between the completion of (neo)adjuvant therapy and disease recurrence is > 12 months
• Prior taxane in the metastatic setting is allowed, provided that the agent administered in the metastatic setting was not standard paclitaxel
• Any number of prior endocrine therapies is allowed and must be discontinued prior to randomization
• Any number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed >= 28 days prior to randomization
• Prior treatment with an investigational agent is allowed but must have been completed >= 28 days prior to randomization with resolution of all treatment-related toxicities to grade =< 1.
• Minor surgical procedures must be completed >= 7 days prior to randomization with documentation of adequate recovery from associated complications to grade =< 1; these include (but are not limited to) laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, endoscopic ultrasonography, skin biopsy, percutaneous needle biopsy, and routine dental procedures; as a precautionary measure, it is recommended, but not strictly required, that placement of a central venous access device, thoracentesis, or paracentesis be done 7 days before the initiation of protocol directed chemotherapy with documentation of adequate recovery from associated complications to grade =< 1
• Major surgical procedures and open biopsies must be completed >= 28 days prior to randomization with documentation of adequate recovery from associated complications to grade =< 1
• Prior radiotherapy must be completed >= 14 days prior to randomization with documentation of adequate recovery from associated toxicities to grade =< 1
• Treatment with bisphosphonates or denosumab is allowed and recommended per the standard of care
• Therapeutic anticoagulation is allowed for patients on a stable dose of warfarin or low molecular weight heparin

You may not qualify if…

• Prior malignancy, other than carcinoma in situ of the cervix and non-melanoma skin cancers, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously, there is no subsequent evidence of recurrence, and the patient is considered by a physician to be at < 30% risk of relapse
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Presence of a serious nonhealing wound, ulcer, or bone fracture
• History of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 hypersensitivity to paclitaxel or Cremophor EL
• Pre-existing peripheral neuropathy grade ?= 2 at registration
• Significant cardiovascular impairment (e.g., New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
• Subjects with known positive human immunodeficiency virus (HIV) status
• History of stroke or transient ischemic attack =< 6 months prior to registration
• History of uncontrolled seizures; (Note: patients are eligible for the study if the seizures are well controlled with standard medications)
• Severe or uncontrolled intercurrent illness/infection
• Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer
• Prior exposure to eribulin mesylate

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Illinois — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Carle Cancer Center NCI Community Oncology Research Program — Urbana, Illinois, United States
• Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
• Iowa-Wide Oncology Research Coalition NCORP — Des Moines, Iowa, United States
• Siouxland Regional Cancer Center — Sioux City, Iowa, United States
• Cancer Center of Kansas - Wichita — Wichita, Kansas, United States
• Ochsner NCI Community Oncology Research Program — New Orleans, Louisiana, United States
• Lafayette Family Cancer Center-EMMC — Brewer, Maine, United States
• Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
• Essentia Health NCI Community Oncology Research Program — Duluth, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• Heartland Regional Medical Center — Saint Joseph, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Heartland Cancer Research CCOP — St Louis, Missouri, United States
• Cancer Alliance of Nebraska — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• New Hampshire Oncology Hematology PA-Hooksett — Hooksett, New Hampshire, United States

Full record on ClinicalTrials.gov

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