NCT00006110

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 1998

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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

December 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

June 1, 2017

Enrollment Period

13.3 years

First QC Date

August 3, 2000

Results QC Date

April 5, 2017

Last Update Submit

June 30, 2017

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.

    Doxorubicin + cyclophosphamide in combination with paclitaxel and trastuzumab (AC-TP) Associated Systolic Dysfunction. Systolic function was measured by the ventricular ejection fraction (LVEF). LVEF is a measurement in determining how well your heart is pumping out blood and in diagnosing and tracking heart failure.

    78 weeks (1.5 years)

Secondary Outcomes (2)

  • Overall Response

    78 weeks (1.5 years)

  • Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.

    5 years

Study Arms (2)

Neo-adjuvant Herceptin with or without radiation

EXPERIMENTAL

Chemotherapy followed by Taxol plus Herceptin followed by surgery followed by radiation (or no radiation) followed by additional Herceptin

Biological: trastuzumabDrug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: paclitaxelProcedure: conventional surgery

Non-Herceptin with or without radiation

EXPERIMENTAL

Chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)

Drug: cyclophosphamideDrug: doxorubicin hydrochlorideDrug: paclitaxelProcedure: conventional surgery

Interventions

trastuzumabBIOLOGICAL

infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks

Also known as: Herceptin
Neo-adjuvant Herceptin with or without radiation
cyclophosphamideDRUG

600 mg/m2, intravenous infusion every 3 weeks for four cycles

Also known as: Lyophilized Cytoxan, Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cycloblastin
Neo-adjuvant Herceptin with or without radiationNon-Herceptin with or without radiation
doxorubicin hydrochlorideDRUG

60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks

Also known as: Adriamycin
Neo-adjuvant Herceptin with or without radiationNon-Herceptin with or without radiation
paclitaxelDRUG

90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)

Also known as: Taxol
Neo-adjuvant Herceptin with or without radiationNon-Herceptin with or without radiation
conventional surgeryPROCEDURE

Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting

Neo-adjuvant Herceptin with or without radiationNon-Herceptin with or without radiation

Eligibility Criteria

Age1 Year - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast
  • Fine needle aspiration, core needle biopsy, or incisional biopsy allowed
  • No excisional biopsy
  • Any of the following:
  • Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)
  • Any T with N2 (including axillary lymph nodes matted to one another) or N3
  • Any T4, including inflammatory breast cancer
  • Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor
  • Supraclavicular or infraclavicular positive lymph nodes without distant metastases
  • Distant metastases with measurable disease in breast or lymph nodes
  • Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria
  • Measurable or evaluable disease
  • PATIENT CHARACTERISTICS:
  • Age: Not specified
  • Sex: Female
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7305, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

TrastuzumabCyclophosphamideDoxorubicinPaclitaxel

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 CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Results Point of Contact

Title
Robin V. Johnson
Organization
UNC Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • Lisa A. Carey, MD

    UNC Lineberger Comprehensive Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

December 1, 1998

Primary Completion

March 1, 2012

Study Completion

April 1, 2013

Last Updated

July 31, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)