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NEO-ADIXERN (NEO-ADjuvant IXabepilone in ER-Negative Breast Cancer). A Feasibility Study of Dose-Dense FEC With G-CSF Support Followed by Dose-Dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in ER-Negative Breast Cancer


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

NEO-ADIXERN (NEO-ADjuvant IXabepilone in ER-Negative Breast Cancer). A Feasibility Study of Dose-Dense FEC With G-CSF Support Followed by Dose-Dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in ER-Negative Breast Cancer


Inclusion Criteria:



- Histological documented diagnosis of breast cancer by incisional biopsy

- Clinical T>=2

- ER negative breast cancer, independently from PgR and HER2 status

- Females age >= 18 and <= 70 years

- ECOG performance status 0-1

- No prior treatment for breast cancer excluding therapy for DCIS

- Subjects with hormone replacement therapy are eligible if this therapy is
discontinued at least 2 weeks before starting therapy

- Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L

- Total bilirubin < 1 time the upper limit of normal (ULN) of the Institutional normal
values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN

- Serum creatinine < 1.5 times the upper limit of normal (ULN)

- Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or
Echocardiography with EF only in HER-2 positive patients)

- Negative pregnancy test prior to inclusion in the study (if potentially childbearing)

- Signed Informed consent

Exclusion Criteria:

- Prior or current history of ipsilateral or controlateral breast invasive cancer. A
past or current history of ipsilateral ductal carcinoma in situ or
ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as
well as a controlateral ductal carcinoma in situ removed by mastectomy

- Inflammatory breast cancer

- Metastatic breast cancer (M1)

- Histology other than adenocarcinoma of the breast

- Male patients

- Pregnant or lactating women or women of childbearing potential (e.g. not using
adequate contraception)

- Patients unwilling or unable to use an acceptable method to avoid pregnancy for the
entire study period and for up to 8 weeks after the last dose of investigational drug

- History of prior or concomitant malignancies other than curatively treated basal cell
skin cancer or excised cervical carcinoma in situ

- Symptomatic peripheral neuropathy > grade 1 according to the NCI CTC

- Other serious illness or medical condition:

- Congestive hearth failure or angina pectoris even if it is medically controlled. In
particular, Ejection Fraction (EF) below the Institutional normal value for MUGA
Fraction (EF) below the Institutional normal value for MUGA, or below 50% for ECHO

- Previous history of myocardial infarction uncontrolled, high-risk ipertension or
arrhythmia

- History of significant neurological or psychiatric disorders including dementia or
seizures

- Active infection, active peptic ulcer, unstable diabetes mellitus or
contraindications for the use of steroids

- History of previous or concomitant malignancies other than curatively treated basal
cell skin cancer or excised cervical carcinoma in situ

- Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational regimen within 30 days prior to study entry

- Prior severe HSR to agents containing Cremophor EL

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathologic Complete Response (pCR)

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Marco MV Venturini, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ospedale Sacro Cuore - Dipartimento di Oncologia Medica

Authority:

Italy: Ministry of Health

Study ID:

GIM9-NEO-ADIXERN

NCT ID:

NCT00751868

Start Date:

September 2008

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Clinical T score >=2
  • ER negative breast cancer, independently from PgR and HER2 status
  • Females between 18 and 70 years
  • ECOG performance status 0-1
  • No prior treatment for breast cancer excluding therapy for DCIS
  • Histological documented diagnosis of breast cancer by incisional biopsy
  • Breast Neoplasms

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