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)

Borstkanker Onderzoek Groep1 site in 1 country250 target enrollmentApril 2010

ConditionsBreast Cancer

Interventionscyclophosphamide docetaxel doxorubicin hydrochloride zoledronic acid neoadjuvant therapy

Drugscyclophosphamide docetaxel doxorubicin hydrochloride zoledronic acid

Overview

Phase: Phase 3
Intervention: cyclophosphamide
Conditions: Breast Cancer
Sponsor: Borstkanker Onderzoek Groep
Enrollment: 250
Locations: 1
Primary Endpoint: Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

September 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Borstkanker Onderzoek Groep

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Time Frame: after surgery

Secondary Outcomes

Safety and tolerability(during treatment)
Disease-free survival(3 and 5 years)
Heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen(at surgery)
Overall survival(3 and 5 years)
Correlation of clinical response with pathological responses of both treatment arms(after surgery)