Breast Cancer
Conditions
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, invasive ductal breast carcinoma
Brief summary
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer. PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
Detailed description
OBJECTIVES: Primary * To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast. * To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation. Secondary * To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0. * To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale. * To assess the incidence and type of adverse events in the breast of these patients. * To assess the incidence and type of procedure-related complications in these patients. * To determine local control and pattern of recurrence in these patients. * To determine disease-free survival (distant and recurrence-free survival) of these patients. * To determine overall survival of these patients. * To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales. * To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II. * Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years. After completion of study treatment, patients are followed periodically for at least 5 years.
Interventions
RADIATION3-dimensional conformal radiation therapy
Given twice a day for 10 fractions
RADIATIONbrachytherapy
Given twice a day for 10 fractions
Sponsors
Cancer Trials Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Pathologically proven invasive ductal carcinoma of the breast * Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease) * No T2 (tumor size \> 3 cm) or T3 disease * No lymph node (L0) or hemangiosis (V0) invasion * Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast * No multifocal/multicentric disease * Previously treated with breast-conserving surgery with adequate axillary node management * Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ \[DCIS\]) on histology * Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan * Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study * Breast size amenable to partial breast irradiation (i.e., \> A-cup size) * No other pathological invasive tumor or DCIS * No associated extensive DCIS component (\< 25%) * No associated Paget's disease of the nipple * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No breast implants * No collagen vascular disease * No psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy * No concurrent chemotherapy * Sequential chemotherapy allowed * Concurrent hormonal therapy allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successfully delivered accelerated partial breast irradiation | Never established as trial terminated |
Secondary
| Measure | Time frame |
|---|---|
| Local control and pattern of recurrence | Never established as trial terminated |
| Disease-free survival (distant and recurrence-free survival) | Never established as trial terminated |
| Overall survival | Never established as trial terminated |
| Quality of life (e.g., cosmesis and treatment-related symptoms) as assessed by the Breast Cancer Treatment Outcome and RTOG scales | Never established as trial terminated |
| Acute radiation-induced toxicity as assessed by NCI CTCAE v3.0 | Never established as trial terminated |
| Long-term radiation-induced toxicity as assessed by RTOG-EORTC scale | Never established as trial terminated |
| Incidence and type of adverse events in the breast | Never established as trial terminated |
| Incidence and type of procedure-related complications | Never established as trial terminated |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATORPierre Thirion, MD
Saint Luke's Hospital
Outcome results
None listed