Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with large resectable or locally advanced HER2-negative breast cancer.

Phase 3

Completed

Conditions: Breast cancer
10006291

Registration Number: NL-OMON34755

Lead Sponsor: BOOG Study Center B.V

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

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

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.
•Poor dental health.
•Known hypersensitivity reaction to any of the components of the treatment
•Pregnancy or lactating

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to determine the pathologic complete<br /><br>response (pCR) rate to neoadjuvant chemotherapy with or without zoledronic acid<br /><br>at surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Clinical response (partial and complete according to RECIST v 1.1) of<br /><br>neoadjuvant therapy correlated to pathological response.<br /><br>- Disease free survival and overall survival after 3 and 5 years correlated to<br /><br>pCR<br /><br>-Tolerability (grade 3 / 4 CTC toxicities) of both regimens.<br /><br>-Pathology: ER/PR and HER2 heterogeneity in core biopsy vs. operation specimen. </p><br>