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

Sponsored by:	Institute of Cancer Research, United Kingdom
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00814567

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1935
Study Start Date:	October 2006
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I (control): Active Comparator Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.	Procedure: radiation therapy Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Arm II: Experimental Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.	Procedure: radiation therapy Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Arm III: Experimental Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.	Procedure: radiation therapy Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814567

Locations

United Kingdom, England
Royal Marsden - Surrey	Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: John R. Yarnold, MD, FRCR 44-20-8661-3388

Sponsors and Collaborators

Institute of Cancer Research, United Kingdom

Investigators

Principal Investigator:

John R. Yarnold, MD, FRCR

Royal Marsden - Surrey

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000629768, ICR-IMPORT-LOW, ICR-CTSU/2006/10001, ISRCTN12852634, EU-20896
Study First Received:	December 24, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00814567
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage I breast cancer
stage II breast cancer
invasive ductal breast carcinoma
invasive ductal breast carcinoma with predominant intraductal component

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Carcinoma, Ductal, Breast

Breast Diseases
Recurrence
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009