Phase II study, open label, single arm, evaluating the efficacy of neoadjuvant eribulin mesylate in patients with triple negative breast cancer
Phase 1
- Conditions
- Triple negative breast cancer, operable or locally advancedMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004956-12-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LA CURA TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
tumor >= 2 cm
N0-2a
M0
HER2 negative
ER PgR negative
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48
Exclusion Criteria
prior treatment for breast cancer
metastatic cancer
bilateral invasive breast cancer
multicentric breast cancer
pre-existing peripheral neuropathy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Pathological complete response in breast and axilla;Secondary Objective: Clinical objective response rate<br>breast conservation rate<br>safety<br>efficacy of eribulin<br>predictive value of PET;Primary end point(s): pCR;Timepoint(s) of evaluation of this end point: 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ORR<br>metabolic response<br>safety<br>grade 3/4 hematologic toxicity<br>dose reductions and dose delays;Timepoint(s) of evaluation of this end point: 18 months