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Clinical Trials/EUCTR2006-003993-85-IT
EUCTR2006-003993-85-IT
Active, not recruiting
Not Applicable

Phase II Study of neoadjuvant therapy with trastuzumab plus docetaxel followed by trastuzumab plus pegylated liposomal doxorubicin and cyclophosphamide in human ErbB-2-positive operable or locally advanced breast cancer - CETRA

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 sitesJune 13, 2007
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ConditionsOperable breast cancer patients or locally advanced breast cancer patients (stage II-III), with HER2 overexpression or gene amplificationMedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female
DrugsHERCEPTIN*EV 1FL 150MGTAXOTERE*INFUS FL 20MG/0,5ML+FCAELYX*INFUS 1FL 2MG/ML 10MLCAELYX*INFUS 1FL 2MG/ML 25MLENDOXAN BAXTER*INIET 10FL200MGENDOXAN BAXTER*EV 1FL 500MGENDOXAN BAXTER*EV 1FL 1G

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Operable breast cancer patients or locally advanced breast cancer patients (stage II-III), with HER2 overexpression or gene amplification
Sponsor
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 13, 2007
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Eligibility Criteria

Inclusion Criteria

  • •? Histologically confirmed HER2\-positive (immunohistochemistry \[IHC 3\+] or fluorescence or chromogenic in situ hybridization \[FISH\+, CISH\+]) breast cancer ? Stage II\-IIIB (T0\-1\-2\-3\-4\-N\+\-M0, T2\-3\-4\-N0\-M0\) ? Age ? 18 and \< 65 years ? ECOG Performance Status 0\-1 ? Life expectancy \>3 months ? Neutrophils ? 2 x 109/L and Platelets ?100 x 109/L ? Total bilirubin ?1\.25 time the upper\-normal limits (UNL) of the Institutional normal values and ASAT (GOT) and/or ALAT (GPT) ? 1\.25 UNL. ? Creatinine ? 1\.25 the UNL ? Normal Left Ventricular Ejection Fraction (LVEF) \>50% (evaluated by MUGA scan or ultrasonography ? only one method must be employed for an individual patient). ? Signed informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •? Stage IV ? Prior chemotherapy ? History of prior malignancy in the last 10 years (other than non\-melanoma skin cancer or excised cervical carcinoma in situ). ? Other serious illness or medical condition ? Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia ? History of significant neurological or psychiatric disorders including dementia or seizures ? Active infection ? Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening ? Geographic inaccessibility for treatment and follow up ? Pregnant or lactating women

Outcomes

Primary Outcomes

Not specified

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