Studieoverzicht - 2010-01 NEO-ZOTAC
Number | 2010-01 NEO-ZOTAC | ||||
Nickname | NEO-ZOTAC | ||||
Status | Closed | Date: 06-09-2018 | |||
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 ClinicalResearchCenter@lumc.nl E-mail datacenter@lumc.nl |
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Monitoring | ||||
Local datamanagement | IKNL | |||
Funding |
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Extra | De database is gesloten op 6-9-2018. Follow-up is beperkt tot 5 jaar. |
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 (public):
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