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Clinical Trials/EUCTR2008-006383-10-IT
EUCTR2008-006383-10-IT
Active, not recruiting
Not Applicable

A phase II randomized study evaluating the role of 8 courses of primary chemotherapy versus 4 courses of primary chemotherapy in combination with endocrine therapy in locally advanced breast cancer. - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 sitesDecember 15, 2008
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Conditionslocally advanced breast cancerMedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female
DrugsFEMARA*30CPR RIV 2,5MGNAVELBINAFLUOROURACILE TEVA*IV 5G 100MLCISPLATINO TEVA*EV 10MG 20MLCISPLATINO TEVA*EV 50MG 100MLGONAPEPTYL DEPOT*SIR 3,75MG+SO

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
locally advanced breast cancer
Sponsor
ISTITUTO EUROPEO DI ONCOLOGIA
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 15, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Pre\- or post\-menopausal women with histologically proven locally advanced primary breast cancer (cT2\-T3\-T4 a\-c, N0\-3c, M0\) or local recurrence after breast conserving surgery (rT1\-T4a\-c, N0\-3c, M0\) or local recurrence after mastectomy (M1 on the chest wall) or regional recurrence (axillary, supraclavicular and internal mammary chain lymph nodes)
  • •\-Patients must be suitable for local treatment (surgery and/or radiotherapy) in a multidisciplinary program
  • •\- ER or PgR 0\-49% of the cells and HER2 neg
  • •\-Measurable and/or evaluable lesions
  • •\-Age \&\#61619;18 years
  • •\-ECOG performance status \&\#61603;2 (Karnofsky \&\#61619;60%)
  • •\-Normal organ and marrow function.
  • •\-No evidence of distance metastases
  • •\-Geographically accessible for follow up.
  • •\-Women of child\-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

  • •Presence of distant metastases
  • •\-Presence of HER2/neu overexpression or amplification of HER2/neu gene
  • •\-Previous or concomitant other malignancy, including, except prior ipsilateral or contralateral invasive breast cancer or synchronous bilateral breast cancer with the same immunohistochemical features, basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix.
  • •\-Clinical grade greater than or equal to 2 peripheral neuropathy.
  • •\-Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • •\-Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents included in this trial. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued.

Outcomes

Primary Outcomes

Not specified

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