NCT00533936

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether trastuzumab is more effective than observation when given after combination chemotherapy and trastuzumab in treating patients with breast cancer. PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works compared with observation when given after combination chemotherapy and trastuzumab in treating patients undergoing surgery for stage II or stage III breast cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

August 26, 2013

Status Verified

March 1, 2008

Enrollment Period

3.3 years

First QC Date

September 20, 2007

Last Update Submit

August 23, 2013

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage of pathological responses

  • Disease-free survival

Secondary Outcomes (3)

  • Overall survival at 3 years

  • Cardiac toxicity

  • Percentage of patients that become negative on the fluorescence in situ hybridization (FISH) test at the end of neoadjuvant therapy

Interventions

trastuzumabBIOLOGICAL
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
fluorouracilDRUG
paclitaxelDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer by needle biopsy * Diagnosed within the past 4 weeks * Clinical stage IIB, IIIA, IIIB, or IIIC disease * Palpable adenopathies present * HER2/neu-positive disease, as evidenced by either of the following: * HER2/neu overexpression (3+) by immunohistochemistry (IHC) * HER2/neu amplification by fluorescence in situ hybridization (FISH) * No metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available) * Hormone receptor status: * Estrogen receptor and/or progesterone receptor status known PATIENT CHARACTERISTICS: * Premenopausal or postmenopausal * WHO performance status 0-2 * Not pregnant or nursing * Normal hepatic, renal, and hematological function * LVEF ≥ 55% by nuclear medicine study or echocardiogram * No prior history of cancer, except carcinoma in situ of the cervix * No allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (Herceptin®) PRIOR CONCURRENT THERAPY: * No prior cancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14000, Mexico

RECRUITING

Hospital General de Mexico

Mexico City, Mexico City, C.P. 06726, Mexico

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabCyclophosphamideDoxorubicinFluorouracilPaclitaxelChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Claudia Arce-Salinas, MD

    Instituto Nacional de Cancerologia, Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Last Updated

August 26, 2013

Record last verified: 2008-03

Locations

ME(2)