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Clinical Trials/EUCTR2009-016932-11-NL
EUCTR2009-016932-11-NL
Active, not recruiting
Not Applicable

Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with HER2-negative breast cancer. - NEO-ZOTAC

BOOG Study Center B.V0 sitesJanuary 6, 2010
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DrugsZoledronic Acid/ZometaNeulastaTaxotereEndoxanDoxorubin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
BOOG Study Center B.V
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 6, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
BOOG Study Center B.V

Eligibility Criteria

Inclusion Criteria

  • •Women presenting with large resectable or locally advanced breast cancer (T2 \=2 cm and positive lymph nodes, T2 \= 3cm? T3,T4, every N, M0\)
  • •Measurable disease (breast and/or lymph nodes)
  • •Histological proven HER2\-negative breast cancer in the core biopsy material.
  • •Age \=18 years
  • •Adequate bone marrow function (within 14 days prior to registration): WBC \=3\.0 x 109/l, neutrophils \=1\.5 x 109/l, platelets \=100 x 109/l
  • •Adequate liver function (within 4 weeks prior to start treatment): bilirubin \=1\.5 x upper limit of normal (UNL) range, ALAT and/or ASAT \=2\.5 x UNL, Alkaline Phosphatase \=5 x UNL
  • •Adequate renal function: the calculated creatinine clearance should be \=50 ml/min
  • •Patients must be accessible for treatment and follow\-up
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •Evidence of distant metastases (M1\)
  • •Prior surgery other than biopsy
  • •Prior chemotherapy or radiation therapy
  • •Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre\-invasive carcinoma of the cervix.
  • •Prior bisphosphonate usage.
  • •Peripheral neuropathy \> grade 2, whatever the cause
  • •Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.

Outcomes

Primary Outcomes

Not specified

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