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Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer


Phase 3
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment

Safety Issue:

No

Principal Investigator

John R. Yarnold, MD, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000629768

NCT ID:

NCT00814567

Start Date:

October 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IA breast cancer
  • stage II breast cancer
  • invasive ductal breast carcinoma
  • invasive ductal breast carcinoma with predominant intraductal component
  • Breast Neoplasms

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