NCT00005983

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
98

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jun 2000

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

4.8 years

First QC Date

July 5, 2000

Last Update Submit

January 22, 2013

Conditions

Breast Cancer

Keywords

stage II breast cancer

Study Arms (2)

surgery

ACTIVE COMPARATOR

surgery followed by observation

Procedure: surgery

surgery followed by RT

EXPERIMENTAL

Surgery followed by radiation therapy

Radiation: radiation therapyProcedure: surgery

Interventions

radiation therapyRADIATION
surgery followed by RT
surgeryPROCEDURE

surgery

surgerysurgery followed by RT

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0) * Primary tumor no greater than 5 cm * At least 1 but no more than 3 positive axillary lymph nodes * Nodes cannot be positive solely by cytokeratin staining * No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast * No bilateral breast cancer * No active local regional disease * Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months * Surgical margins negative for invasive and noninvasive ductal carcinoma * No gross extracapsular disease or residual disease in the axilla * Microscopic extracapsular extension allowed * No mastectomy after local failure following lumpectomy * Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 21 and over Sex: * Female Menopausal status: * Pre- or post-menopausal Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * See Disease Characteristics * No more than 6 weeks since prior adjuvant chemotherapy * No other prior chemotherapy * Concurrent adjuvant chemotherapy allowed Endocrine therapy: * See Disease Characteristics * Concurrent adjuvant hormonal therapy allowed Radiotherapy: * No prior chest wall or nodal radiotherapy Surgery: * See Disease Characteristics * Breast reconstruction allowed Other: * Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed

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

Sponsors & Collaborators

Study Sites (1)

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lori J. Pierce, MD

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

  • Michael G. Haddock, MD

    Mayo Clinic

    STUDY CHAIR

  • Stephen B. Edge, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

  • Eric A. Strom, MD, FACR

    M.D. Anderson Cancer Center

    STUDY CHAIR

  • Lawrence J. Solin, MD, FACR

    Abramson Cancer Center at Penn Medicine

    STUDY CHAIR

  • Lawrence B. Marks, MD

    Duke University

    STUDY CHAIR

  • Timothy J. Whelan, MD

    Margaret and Charles Juravinski Cancer Centre

    STUDY CHAIR

  • Melvin Deutsch, MD

    UPMC Cancer Center at UPMC Presbyterian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

CA(1)