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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34755

Enrollment

250

Registered

2010-01-05

Start date

2010-07-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Arm A: Zoledronic acid 4 mg i.v in 15 minutes every 3-weeks within 24 hours after infusion of chemotherapy, repeated every 21 days for 6 cycles

Eligibility

Age

18 Years to 99 Years

Inclusion 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 •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 =50 ml/min

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)