Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00814567
First received: December 24, 2008
Last updated: January 6, 2011
Last verified: December 2008

December 24, 2008
January 6, 2011
October 2006
June 2010   (final data collection date for primary outcome measure)
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment [ Designated as safety issue: No ]
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumour) as confirmed by cytological or histological assessment [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00814567 on ClinicalTrials.gov Archive Site
  • Location of tumor relapse [ Designated as safety issue: No ]
  • Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment [ Designated as safety issue: No ]
  • Regional and distant metastases [ Designated as safety issue: No ]
  • Late adverse effects in normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments [ Designated as safety issue: Yes ]
  • Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years [ Designated as safety issue: No ]
  • Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery
Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.

OBJECTIVES:

  • To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.

OUTLINE: This is a multicenter study.

Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
  • Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
  • Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.

All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays.

Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years.

After completion of study treatment, patients are followed for 10 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
Radiation: radiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
  • Active Comparator: Arm I (control)
    Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
    Intervention: Radiation: radiation therapy
  • Experimental: Arm II
    Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
    Intervention: Radiation: radiation therapy
  • Experimental: Arm III
    Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
    Intervention: Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1935
Not Provided
June 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of low-risk early stage breast cancer, meeting the following criteria:

    • Invasive adenocarcinoma

      • No invasive carcinoma of classical lobular type
      • No lymphovascular invasion
    • Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component)
    • Unifocal disease
    • Grade I, II, or III disease
    • Axillary lymph nodes negative (pN0)

      • Sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed
  • Must have undergone breast conservation surgery with or without adjuvant systemic therapy

    • Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
  • At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence)
  • No prior mastectomy
  • No blood-borne metastases

PATIENT CHARACTERISTICS:

  • No prior malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior endocrine therapy or chemotherapy

    • Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met
    • No primary endocrine therapy as a replacement for surgery
  • No concurrent chemoradiotherapy
Female
50 Years and older
No
United Kingdom
 
NCT00814567
CDR0000629768, ICR-IMPORT-LOW, ICR-CTSU/2006/10001, ISRCTN12852634, EU-20896
Not Provided
Not Provided
Institute of Cancer Research, United Kingdom
Not Provided
Principal Investigator: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP