A multicenter randomized phase II clinical trial with neo -adjuvant chemotherapy containing eribulin mesylate for triple negative primary breast cancer patients (Neo-Entrance study)
- Conditions
- Patients with operable primary triple-negative breast cancer without prior treatment
- Registration Number
- JPRN-UMIN000023162
- Lead Sponsor
- Japan Breast Cancer Research Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 100
Not provided
(1) Bilateral invasive breast cancer whether metachronous,concurrent or bilateral DCIS. Contralateral DCIS after mastectomy (Bt), skin-sparing mastectomy (SSM), nipple-sparing mastectomy (NSM), or equivalent are permitted. (2) Pt with multiple cancers other than breast cancer (3) Pt with axillary lymph node dissection before pre-operative chemotherapy (4) Pt with incisional or excisional biopsies for primary lesion or axillary lymph node (5) Participation in another clinical trial within 28 days after the second registration (6) Pt with peripheral neuropathy >= NCI CTCAE v.4.03 Grade 2 (7) Pt with cardiopulmonary dysfunctions within six months before the second registration (8) Pt with myocardial infarction within 12 months before the second registration (9) Pt with severe uncontrolled systemic diseases (10) Pt who undergone major surgery or serious trauma within 28 days before the second registration, or who will have a major surgery during this trial. (11) Pt with severe infectious disease requiring intravenous administration of antibiotics, antiviral agents, or anti-fungal agents at the second registration (12) Pt with dental caries and/or oral infections requiring treatment (13) Pt with diagnosed of active liver disease or sclerosing cholangitis caused by autoimmune liver disorders (14) Pt with HIV infection (15) Lactating Pt (16)Other diseases that are considered to affect consent acquisition or protocol compliance by an investigator or sub-investigator. (17) Pt with hypersensitive to the study drug or additives and with DPD deficiency (18) Pt with difficulty of the oral ingestion, dysfunction of the upper gastrointestinal tract and malabsorption syndrome ( only in case HRD negative or age>=65 years at consent acquisition) (19) Pt determined to be ineligible by an investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response evaluated by the Central Decision Institution [CpCRypN0 (ypT0-TisypN0)]
- Secondary Outcome Measures
Name Time Method