Doxorubicin Hydrochloride, Cyclophosphamide, and Docetaxel With or Without Zoledronic Acid in Treating Patients With Large Resectable or Locally Advanced Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01099436
First received: April 6, 2010
Last updated: August 13, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: zoledronic acid
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099436

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 RC
Contact: Contact Person    31-71-526-3464    j.r.kroep@lumc.nl   
Sponsors and Collaborators
Borstkanker Onderzoek Groep
Investigators
Principal Investigator: Judith Kroep, MD Leiden University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01099436     History of Changes
Other Study ID Numbers: CDR0000669246, BOOG-2010-01, BOOG-NEO-ZOTAC, EUDRACT-2009-016932-11, EU-21023
Study First Received: April 6, 2010
Last Updated: August 13, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Doxorubicin
Zoledronic acid
Diphosphonates
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014