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Status:

UNKNOWN

Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy

Lead Sponsor:

Medical Research Council

Conditions:

Breast Cancer

Eligibility:

FEMALE

Phase:

PHASE3

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is n...

Detailed Description

OBJECTIVES: * Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy. OU...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed unilateral invasive breast cancer
  • pT1, pN1, M0 disease
  • pT2, pN1, M0 disease
  • pT2, pN0 disease with grade III histology and/or lymphovascular invasion
  • Multifocal breast cancer meeting both of the following criteria:
  • Largest discrete tumor ≥ 2 cm if N0
  • Grade III histology and/or lymphovascular invasion
  • No bilateral breast cancer
  • Axillary node negative status by axillary clearance, axillary node sampling, or sentinel node biopsy
  • Patients with axillary node positive (1-3 positive nodes, including micrometastases\* \> 0.2 mm and ≤ 2 mm) must have had an axillary node clearance (minimum of 10 nodes removed) performed
  • No more than 3 pathologically involved lymph nodes
  • No internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology NOTE: \*Isolated tumor cells not counted as micrometastases
  • Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and DCIS) and axillary surgery with staging procedure
  • Must have undergone adjuvant systemic chemotherapy if indicated for intermediate-risk breast cancer
  • Patients undergoing immediate breast reconstruction allowed
  • No known BRCA1 and BRCA2 carriers
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • Not pregnant
  • Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative radiotherapy
  • No prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No concurrent trastuzumab
  • No prior neoadjuvant systemic therapy

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    3500 Patients enrolled

    Trial Details

    Trial ID

    NCT00966888

    Start Date

    January 1 2006

    Last Update

    August 12 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, United Kingdom, EH4 2XU

    2

    Royal Infirmary - Castle

    Glasgow, Scotland, United Kingdom, G4 0SF