Patients with HER2-negative, Stage IIIA (T2-3 and N2 only), Stage IIIB, and Stage IIIC locally advanced infiltrating breast cancer who have no prior treatment
Conditions
Interventions
Sequential concomitant use of eribulin
Sponsors
JBCRG (Japan Breast Cancer Research Group)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women at least 20 years of age but not older than 70 2) ECOG performance status (PS) is 0 to 1. 3) Locally advanced breast cancer of Stage IIIA (T2-3 and N2 only), stage IIIB, and Stage IIIC. 4) Histologically diagnosed with infiltrating breast cancer. 5) HER2 negative (1+ or 0 with IHC method. In the case of 2+ with IHC method, no amplification of HER2 gene should be observed in FISH or DISH method. Can be judged with FISH/DISH method alone, without IHC test.) 6) The regimen of this clinical study (anthracycline-taxane-eribulin) was indicated by mutual consent of primary physician and study center conference, considering the other treatments such as surgery, radiation therapy, and other systemic drug therapy. 7) Conducting imaging analysis of original lesion using MRI, CT, or breast ultrasonography prior, during, and after the treatment is possible (if the patient is allergic to contrast agent, conducting only breast ultrasonography is acceptable). 8) No prior treatment of breast cancer (chemotherapy, hormone therapy, molecular target therapy, radiation therapy, and immune therapy). 9) Patients who can take drug therapy with anthracycline and taxane and plan to take 2 to 4 courses of each treatment. 10) Main organ function (bone marrow, heart, liver, kidney, etc.) is not impaired. The values of laboratory findings within 28 days prior to the registration meet all of the followings. (1) neutrophil count: =>1,500/mm3 (2) platelet count: =>100,000 mm3 (3) hemoglobin: =>9.0 g/dL (4) total bilirubin: <=2.0 mg/dL (5) AST (GOT), ALT (GPT): <=100IU (6) serum creatinine <=1.5 mg/dL (11) Patients with life expectancy of 12 months or longer from the initial registration. (12) Patients without clinical problems in electrocardiogram. (13) Patients who submitted written informed consent signed by the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with coexisting active infection or cases with pyrexia suspected of infection. 2) Cases with diarrhea (watery feces), intestinal paralysis, and intestinal obstruction. 3) Cases of fresh bleeding from gastrointestinal tract. 4) Cases with serious drug allergy. 5) Cases with serious renal disorder and hepatic disorder (jaundice). 6) Cases with clear indications of interstitial pneumonia or pulmonary fibrosis in chest X-ray. 7) Cases with large pleural/peritoneal effusion (patients required drainage) 8) Patients with difficult-to-control concomitant symptoms (hypertension with systolic/diastolic =>180/110 mmHg, cardiac infarction within 6 months, congestive heart failure, hepatic failure, arrhythmia that requires treatment, moderate cardiac valvulopathy, infection, hemorrhagic tendency, brittle diabetes mellitus, dyspnea at rest, long term oxygen therapy, serious edema, serious peripheral neuropathy, etc.) 9) Patients with cardiac dysfunction of NYHA Class III or IV. 10) Cases with continuous systemic administration (oral or intravenous) of steroid. 11) Pregnant patients or patients with possible pregnancy. 12) Active multiple primary cancer (Simultaneous multiple primary cancer and nonsimultaneous multiple primary cancer with disease-free interval of 5 years or shorter. Carcinoma in situ judged as treatable with local treatment or lesions of intramucosal carcinoma are not included in active multiple primary cancer.) 13) Cases with preexisting condition of psychiatric disorder or central nervous system disorder. 14) Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical response rate of sequential therapy with anthracycline, taxane, and eribulin | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The histological response rate of sequential therapy with anthracycline, taxane, and eribulin. (2) Clinical efficacy, rate of radical surgery, and rate of breast-conserving surgery. (3) Safety evaluation (occurrence of adverse events) (4) Exploration of clinicopathological and molecular biological markers related to prediction of cytoreductive effects. (5) Overall survival and recurrence-free survival (6) Clinical efficacy of eribulin after the treatment with anthracycline and taxane. Exploratory endpoints: Exploratory assessment of differences in response rate of eribulin with differences in sequence of administration of anthracycline and taxane. | — |
Countries
Japan
Contacts
Public ContactJun Fukase
JBCRG (Japan Breast Cancer Research Group) Head Office
Outcome results
None listed