Studieoverzicht - 2010-01 NEO-ZOTAC

 
Number 2010-01 NEO-ZOTAC
Nickname NEO-ZOTAC
Status Follow up Date: 05-04-2012
Inclusion closed 05-04-2012
Other study number(s)
Participating parties/groups
Full title A phase III randomized trial with NEOadjuvant chemotherapy (TAC) with or without ZOledronic acid for patients with HER2-negative large resectable or locally advanced breast cancer
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Neoadjuvant
Subindication HER2-, any HR
Target sample size 250
Actual accrual 250 Date: 05-04-2012
Estimated study completion date 31-12-2012
CCMO approval Yes Date: 05-01-2010 Nr: NL30600.058.09
EudraCT nr. 2009-016932-11
Trial Register NCT01099436
METC approval Yes Date: 08-03-2010 METC: Leiden Universitair Medisch Centrum Nr: P09.250
Amendments Yes Date: 06-04-2011
KWF-CKS approval Yes Date: 02-03-2010 Nr: 2010-4682
News item
Website http://www.boogstudycenter.nl
Sponsor BOOG Study Center
Principal Investigator(s) J.R. Kroep, J.W.R. Nortier, G.J. Liefers
Study manager A. Charehbili, A.E. van Leeuwen-Stok
Central datamanagement and randomization Leiden University Medical Center
Datacenter Surgery K6-R
P.O. Box 9600, 2300 RC Leiden
Phone +31 71 526 3500
Fax +31 71 526 6744
E-mail datacenter@lumc.nl
Monitoring
Local datamanagement IKNL
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

Randomization:
Arm A: 6x TAC with Zoledronic acid
Arm B: 6x TAC without Zoledronic acid

Objectives:

Primary objective:

  • To determine the value of adding zoledronic acid to neoadjuvant chemotherapy with TAC in patients with large resectable or locally advanced HER2-negative breast cancer.

Secondary objectives:

  • To evaluate the clinical response, correlated to the pathological responses of both treatment arms.
  • To evaluate the disease free survival and overall survival.
  • To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant chemotherapy.
  • To evaluate heterogeneity of the ER/PR and HER2 measurement of the core biopsy and the operation specimen.
Endpoints:

Primary endpoint:

  • Pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery.
     

Secondary endpoints:

  • Clinical response (partial and complete according to RECIST v1.1, evaluated with MRI) of neoadjuvant therapy correlated to pathological response.
  • Disease free survival and overall survival after 3 and 5 years follow up, correlated to pCR.
  • Tolerability (grade 3 / 4 CTC toxicities) of both regimens.
  • Pathology: ER/PR and HER2 heterogeneity in core biopsy vs. Operation specimen.
Main eligibility criteria:

Inclusion:

  • Women presenting with large resectable or locally advanced breast cancer (T2,T3,T4, every N, M0)
  • Measurable disease (breast and/or ymph nodes)
  • Histological proven HER2-negative breast cancer in the core biopsy material.
  • Age ≥18 years
  • WHO 0-2
  • Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 10E9/l, neutrophils ≥1.5 x 10E9/l, platelets ≥100 x 10E9/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

Exclusion:

  • Evidence of distant metastases (M1)
  • History of breast cancer
  • Prior breast 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.
  • Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), or a current or prior diagnosis of osteonecrosis of the jaw requiring maxillofacial
    surgery.Known hypersensitivity reaction to any of the components of the treatment
  • Pregnancy or lactating
Documents (protected):
In order to see this content you need to be logged on.

Login.

Back