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

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ClinicalTrials.gov Identifier: NCT01099436
Recruitment Status : Completed
First Posted : April 7, 2010
Last Update Posted : July 16, 2014
Sponsor:
Collaborators:
Dutch Cancer Society
Amgen
Sanofi
Novartis
Information provided by (Responsible Party):
Borstkanker Onderzoek Groep

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: zoledronic acid Procedure: neoadjuvant therapy Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: TAC + Zoledronic acid
six cycles of docetaxel (Taxotere®), Adriamycin® (endoxan) and Cyclofosfamide (TAC) and zoledronic acid (Zometa)
 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)
 Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Procedure: neoadjuvant therapy


Outcome Measures
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Primary Outcome Measures :
  1. Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic [ Time Frame: after surgery ]

Secondary Outcome Measures :
  1. Correlation of clinical response with pathological responses of both treatment arms [ Time Frame: after surgery ]
  2. Disease-free survival [ Time Frame: 3 and 5 years ]
  3. Overall survival [ Time Frame: 3 and 5 years ]
  4. Safety and tolerability [ Time Frame: during treatment ]
  5. Heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen [ Time Frame: at surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099436


Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Borstkanker Onderzoek Groep
Dutch Cancer Society
Amgen
Sanofi
Novartis
Investigators
Principal Investigator: Judith Kroep, MD Leiden University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Borstkanker Onderzoek Groep
ClinicalTrials.gov Identifier: NCT01099436     History of Changes
Other Study ID Numbers: BOOG-2010-01
CDR0000669246 ( Registry Identifier: PDQ (Physician Data Query) )
BOOG-NEO-ZOTAC ( Other Identifier: BOOG )
2009-016932-11 ( EudraCT Number )
First Posted: April 7, 2010    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Borstkanker Onderzoek Groep:
HER2-negative breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Liposomal doxorubicin
Doxorubicin
Zoledronic acid
Diphosphonates
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Bone Density Conservation Agents