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

Radiation Therapy Oncology Group

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Radiation: 3D-Conformal External Beam

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT01082211

RTOG 1014

CDR0000666991

Details and patient eligibility

About

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.

Full description

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.

Enrollment

65 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: