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

Conditions: Patients with locally advanced or large resectable HER2-negative breast cancer
MedDRA version: 12.1Level: LLTClassification code 10006195Term: Breast cancer NOS stage II
MedDRA version: 12.1Level: LLTClassification code 10006196Term: Breast cancer NOS stage III

Registration Number: EUCTR2009-016932-11-NL

Lead Sponsor: BOOG Study Center B.V

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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
•WHO 0-2
•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:
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) yes
F.1.3.1 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine the pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery. ;Primary end point(s): The primary endpoint of this study is the pathologic complete response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid at surgery. ;Secondary Objective: •Clinical response (partial and complete according to RECIST v 1.1) of neoadjuvant therapy correlated to pathological response.<br>•Disease free survival and overall survival after 3 and 5 years<br>•Tolerability (grade 3 / 4 CTC toxicities) of both regimens.<br>•Pathology: ER/PR and HER2 heterogeneity in core biopsy vs. operation specimen. <br>

Secondary Outcome Measures