Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.

OBJECTIVES:

Primary

• To evaluate skin, breast, and chest wall adverse events occurring within 1 year after completion of 3D-conformal partial-breast re-irradiation following repeat breast-preserving surgery in patients with locally recurrent breast carcinoma.

Secondary

• To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time.
• To evaluate in-breast control rate in patients treated with this regimen.
• To evaluate freedom-from-mastectomy rate in these patients.
• To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to document eradication of CTCs by locoregional therapy.
• To determine whether translational objective will correlate with eradication or presence of CTCs with in-breast recurrence and distant metastasis-free survival.
• To evaluate cosmesis as judged by the patient and independent evaluation.
• To evaluate distant metastasis-free survival, mastectomy-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily, 5 days a week, for 3 weeks.

Some patients undergo blood sample collection at baseline and within 3 weeks after completion of radiotherapy for circulating tumor cells analysis.

Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following radiotherapy.

After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.

DISEASE CHARACTERISTICS:

• Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:

  • Invasive ductal breast carcinoma

  • Medullary ductal breast carcinoma

  • Tubular ductal breast carcinoma

  • Mucinous ductal breast carcinoma

  • Lobular breast carcinoma

  • Ductal carcinoma in situ (DCIS)

    • No Paget disease of the nipple

  • Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be < 30% based on a post-operative, pre-treatment CT scan

  • Tumor size ≤ 3 cm in greatest dimension on pathologic specimen

  • Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)

  • Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension

  • If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:

  • Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment

  • Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)

  • Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented

• If the in-breast recurrence is invasive disease and:

  • No prior ALN dissection or SLN dissection only:

    • Patient is required to undergo axillary evaluation with either a SLN or ALN dissection
    • If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required
    • Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension

  • • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment

    • It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection
    • Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered

  • Prior ALN dissection: positive clinical exam: biopsy required

    • If biopsy is negative, patient is eligible for enrollment
    • If biopsy is positive an ALN dissection is required
    • Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered

• Ipsilateral breast mammogram and MRI within 120 days prior to study entry

• Contralateral breast mammogram within 12 months of study entry

• For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan

• No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla)

• Patients must have a breast technically amenable to partial-breast irradiation

• No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease)

• No skin involvement

• No prior contralateral mastectomy

• Estrogen and progesterone status must be known

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Menopausal status not specified
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer
• No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
• No psychiatric or addictive disorders that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 weeks since prior chemotherapy and recovered
• No concurrent intensity-modulated radiotherapy
• No concurrent chemotherapeutic agents, including trastuzumab