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Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients (NEO-ZOTAC)

This study has been completed.
Sponsor:
Collaborators:
Dutch Cancer Society
Amgen
Sanofi
Novartis
Information provided by (Responsible Party):
Borstkanker Onderzoek Groep
ClinicalTrials.gov Identifier:
NCT01099436
First received: April 6, 2010
Last updated: July 15, 2014
Last verified: July 2014

April 6, 2010
July 15, 2014
April 2010
April 2012   (final data collection date for primary outcome measure)
Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic [ Time Frame: after surgery ] [ Designated as safety issue: No ]
Value of this regimen [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01099436 on ClinicalTrials.gov Archive Site
  • Correlation of clinical response with pathological responses of both treatment arms [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
  • Heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen [ Time Frame: at surgery ] [ Designated as safety issue: No ]
  • Correlation of clinical response with pathological responses of both treatment arms [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer Patients
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(NEO-ZOTAC)

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and zoledronic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective when given together with zoledronic acid in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying giving doxorubicin hydrochloride together with cyclophosphamide and docetaxel to see how well it works with or without zoledronic acid in treating patients with large resectable or locally advanced breast cancer.

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 between 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: doxorubicin hydrochloride
  • Drug: zoledronic acid
  • Procedure: neoadjuvant therapy
  • Experimental: TAC + Zoledronic acid
    six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
    Interventions:
    • Drug: cyclophosphamide
    • Drug: docetaxel
    • Drug: doxorubicin hydrochloride
    • Drug: zoledronic acid
    • Procedure: neoadjuvant therapy
  • Active Comparator: TAC
    six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC)
    Interventions:
    • Drug: cyclophosphamide
    • Drug: docetaxel
    • Drug: doxorubicin hydrochloride
    • Procedure: neoadjuvant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
September 2013
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01099436
BOOG-2010-01, CDR0000669246, BOOG-NEO-ZOTAC, 2009-016932-11
Yes
Borstkanker Onderzoek Groep
Borstkanker Onderzoek Groep
  • Dutch Cancer Society
  • Amgen
  • Sanofi
  • Novartis
Principal Investigator: Judith Kroep, MD Leiden University Medical Center
Borstkanker Onderzoek Groep
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP