NCT00003050

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Apr 1997

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

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

July 30, 2004

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

November 1, 1999

Last Update Submit

May 20, 2014

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Interventions

cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
paclitaxelDRUG
tamoxifen citrateDRUG
surgical procedurePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven, untreated, locally advanced breast cancer; stage IIB (T3 N0), IIIA, or IIIB Measurable disease Not inflammatory breast cancer or other stage IIB (T2 N1) No distant metastases except for positive ipsilateral supraclavicular nodes PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception during and 6 months after treatment Medically and psychologically stable PRIOR CONCURRENT THERAPY: No prior therapy of any type

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

Sponsors & Collaborators

Study Sites (2)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Related Publications (3)

  • Adams S, Chakravarthy AB, Donach M, Spicer D, Lymberis S, Singh B, Bauer JA, Hochman T, Goldberg JD, Muggia F, Schneider RJ, Pietenpol JA, Formenti SC. Preoperative concurrent paclitaxel-radiation in locally advanced breast cancer: pathologic response correlates with five-year overall survival. Breast Cancer Res Treat. 2010 Dec;124(3):723-32. doi: 10.1007/s10549-010-1181-8. Epub 2010 Sep 29.

    PMID: 20878462RESULT

  • Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.

    PMID: 12610186RESULT

  • Formenti SC, Symmans WF, Volm M, Skinner K, Cohen D, Spicer D, Danenberg PV. Concurrent paclitaxel and radiation therapy for breast cancer. Semin Radiat Oncol. 1999 Apr;9(2 Suppl 1):34-42.

    PMID: 10210538RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CyclophosphamideDoxorubicinPaclitaxelTamoxifenSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesStilbenesBenzylidene CompoundsBenzene DerivativesTherapeutics

Study Officials

  • Darcy V. Spicer, MD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 30, 2004

Study Start

April 1, 1997

Primary Completion

March 1, 2000

Study Completion

March 1, 2000

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(2)