Breast Cancer Clinical Trial
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
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.
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.
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.
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
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
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There are 57 Locations for this study
Peoria Arizona, 85381, United States
Burbank California, 91505, United States
Aurora Colorado, 80045, United States
Atlantis Florida, 33462, United States
Chicago Illinois, 60611, United States
Springfield Illinois, 62702, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21229, United States
Columbia Maryland, 21044, United States
Glen Burnie Maryland, 21061, United States
Hyannis Massachusetts, 02601, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grosse Pointe Woods Michigan, 48236, United States
Kalamazoo Michigan, 49007, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Basking Ridge New Jersey, 07920, United States
Livingston New Jersey, 07039, United States
Long Branch New Jersey, 07740, United States
Marlton New Jersey, 08053, United States
New Brunswick New Jersey, 08903, United States
Voorhees New Jersey, 08043, United States
Canandaigua New York, 14424, United States
Commack New York, 11725, United States
New York New York, 10032, United States
Rochester New York, 14620, United States
Rochester New York, 14626, United States
Rochester New York, 14642, United States
Rockville Centre New York, 11570, United States
Sleepy Hollow New York, 10591, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44307, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Cincinnati Ohio, 45267, United States
Sylvania Ohio, 43560, United States
Abington Pennsylvania, 19001, United States
Drexel Hill Pennsylvania, 19026, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19141, United States
Reading Pennsylvania, 19612, United States
Rapid City South Dakota, 57701, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
Menomonee Falls Wisconsin, 53051, United States
Mequon Wisconsin, 53097, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53226, United States
Edmonton Alberta, T6G 1, Canada
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