A Phase III Randomized Trial With Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid for Patients With HER2-Negative Large Resectable or Locally Advanced Breast Cancer (NEO-ZOTAC)
18 Years
N/A
Female
Breast Cancer
Trial Information
A Phase III Randomized Trial With Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid for Patients With HER2-Negative Large Resectable or Locally Advanced Breast Cancer (NEO-ZOTAC)
OBJECTIVES:
Primary
- To determine the value of neoadjuvant chemotherapy comprising doxorubicin
hydrochloride, cyclophosphamide, and docetaxel with or without zoledronic acid in
patients with HER2-negative large resectable or locally advanced breast cancer.
Secondary
- To correlate clinical response with pathological responses in both treatment arms.
- To evaluate the disease-free survival and overall survival of patients treated with
this regimen.
- To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant
chemotherapy.
- To evaluate heterogeneity of the ER/PR and HER2 measurement in core biopsy and the
surgical specimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and
docetaxel IV on day 1. Patients also receive zoledronic acid IV over 15 minutes on day
1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression
or unacceptable toxicity.
- Arm II: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and
docetaxel IV as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Large resectable or locally advanced disease
- T2 (≥ 2 cm and positive lymph nodes), T2 (≥ 3 cm), ≥ T3, T4, any N, M0
disease
- Measurable disease (breast and/or lymph nodes)
- HER2-negative disease by core biopsy
- No evidence of distant metastases (M1)
- No prior breast cancer
PATIENT CHARACTERISTICS:
- Female
- Menopausal status unspecified
- WHO performance status 0-2
- Not pregnant or nursing
- WBC ≥ 3.0 x 10^9/L
- Neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Bilirubin ≤ 1.5 times upper limit of normal (UNL)
- ALT and/or AST ≤ 2.5 times UNL
- Alkaline phosphatase ≤ 5 times UNL
- Creatinine clearance ≥ 50 mL/min
- Accessible for treatment and follow-up
- No previous malignancy within the past 5 years except basal cell carcinoma of the
skin or pre-invasive carcinoma of the cervix
- No peripheral neuropathy > grade 2 (of any cause)
- No other serious diseases including recent myocardial infarction, clinical signs of
cardiac failure, or clinically significant arrhythmias
- No poor dental health
- No known hypersensitivity reaction to any of the components of the treatment
- No medical or psychological condition that, in the opinion of the investigator, would
not permit the patient to complete the study or sign meaningful informed consent
PRIOR CONCURRENT THERAPY:
- No prior breast surgery except for biopsy
- No prior chemotherapy or radiotherapy
- No prior bisphosphonates
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic
Safety Issue:
No
Principal Investigator
Judith Kroep, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leiden University Medical Center
Authority:
Unspecified
Study ID:
CDR0000669246
NCT ID:
NCT01099436
Start Date:
April 2010
Completion Date:
Related Keywords:
- Breast Cancer
- HER2-negative breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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