Know Cancer

forgot password

A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.

Inclusion Criteria:

- Written informed consent, specifically highlighting the molecular characterization of
tumor and genomic samples

- Age ≥18 years

- Histologically confirmed invasive breast carcinoma, with all of the following

- Primary tumor ≥2cm in largest diameter (cT1-3)

- cN0-1

- No evidence of distant metastasis (M0)

- Breast cancer (BC) eligible for primary surgery

- Available pre-treatment core (Tru-cut) biopsy or possibility of performing one

- HER2-negative BC (as per local assessment), defined as either of the following:

- 0-1+ expression by IHC

- 2+ expression by IHC and in situ hybridization (FISH/CISH) without HER2 gene
amplification (<4 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene
copies to Cr17 signals] of <1.8)

- Is situ hybridization (FISH/CISH) without HER2 gene amplification, independently
of IHC

- Known hormone receptor (ER/PgR) status (as per local assessment) or the possibility
of performing the tests

- Known percentage of hormone receptor (ER/PgR) and Ki67-positive tumor cells (as per
local assessment), or possibility of performing the tests

- In the case of a multifocal tumor, the largest lesion must be ≥2 cm and designated
the "target" lesion for all subsequent tumor evaluations and HER2-negative status
must be documented in all the tumor foci

- ECOG performance status of 0 or 1

- Laboratory values as follows:

- Absolute neutrophil count (ANC) ≥1.5 x 109/L

- Platelets count ≥100 x 109/L

- Hemoglobin ≥9 g/dL

- Serum bilirubin ≤1.5 time the upper limit of normal (ULN)

- Alanine aminotransferase and aspartate aminotransferase (AST) ≤2.5 x ULN

- Alkaline phosphatase ≤2.5 x ULN

- Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/m

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule

- Ability and willingness to comply with study visits, treatment, testing, and to
comply with the protocol

- Availability of genomic DNA (via whole blood)

Exclusion Criteria:

- Any prior treatment for primary invasive BC

- Metastatic, locally advanced or inflammatory (i.e., Stage III-IV) BC

- Bilateral invasive BC

- Multicentric BC, defined as the presence of two or more foci of cancer in different
quadrants of the same breast

- Pre-existing peripheral neuropathy of any grade

- Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)

- Clinically significant (i.e., active) cardiovascular disease

- Long QT syndrome

- Concomitant use of inhibitors of hepatic transport proteins such as organic
anion-transporting proteins, P-glycoprotein, multidrug resistant proteins etc

- Major medical conditions that might affect study participation (e.g., uncontrolled
seizure disorder, uncontrolled pulmonary, renal or hepatic dysfunction, or
uncontrolled infection)

- Other primary malignant tumors within the previous 5 years, except for adequately
controlled limited basal cell carcinoma of the skin or carcinoma in situ of the

- Known human immunodeficiency virus(HIV) infection or other active or serious
infection requiring IV antibiotics at randomization

- Pregnancy or breastfeeding women

- Women of childbearing potential(<2 years after the last menstruation) not using
effective, non-hormonal means of contraception during the study and for a period of 6
months following the last administration of study drug

- Administration of any live virus vaccine within 8 weeks preceding study entry

- Use of any investigational agent within 30 days of administration of the first dose
of study drug or concurrent treatment on another clinical study

- Requirement for radiation therapy concurrent with study anticancer treatment

- Known hypersensitivity to any of the study drugs or excipients

- Inability or unwillingness to abide by the study protocol or cooperate fully with the
investigator or designee

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation of pre-treatment relative abundance of hundreds of mRNA transcripts from primary breast tumors with pCRB after neoadjuvant treatment with eribulin.

Outcome Description:

pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines

Outcome Time Frame:

At the time of definitive surgery.

Safety Issue:


Principal Investigator

Javier Cortés, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Vall d´Hebron


Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

August 2012

Completion Date:

August 2017

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Eribulin
  • Neoadjuvant
  • PAM50
  • Triple-negative
  • Luminal A
  • Luminal B
  • Breast Neoplasms