Breast Cancer Clinical Trial

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

Summary

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.

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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.

View Eligibility Criteria

Eligibility 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:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

65

Study ID:

NCT01082211

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 57 Locations for this study

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Arizona Center for Cancer Care - Peoria
Peoria Arizona, 85381, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank California, 91505, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora Colorado, 80045, United States
JFK Medical Center
Atlantis Florida, 33462, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Cancer Institute at St. John's Hospital
Springfield Illinois, 62702, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
St. Agnes Hospital Cancer Center
Baltimore Maryland, 21229, United States
Central Maryland Oncology Center
Columbia Maryland, 21044, United States
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie Maryland, 21061, United States
Cape Cod Hospital
Hyannis Massachusetts, 02601, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
McLaren Cancer Institute
Flint Michigan, 48532, United States
Butterworth Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak Michigan, 48073, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
Barnes-Jewish West County Hospital
Saint Louis Missouri, 63141, United States
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge New Jersey, 07920, United States
St. Barnabas Medical Center Cancer Center
Livingston New Jersey, 07039, United States
Monmouth Medical Center
Long Branch New Jersey, 07740, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton New Jersey, 08053, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Sands Cancer Center
Canandaigua New York, 14424, United States
Memorial Sloan-Kettering Cancer Center
Commack New York, 11725, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York New York, 10032, United States
Highland Hospital of Rochester
Rochester New York, 14620, United States
University Radiation Oncology at Parkridge Hospital
Rochester New York, 14626, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Rockville Centre New York, 11570, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow New York, 10591, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Barberton Citizens Hospital
Barberton Ohio, 44203, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
M. D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Community Memorial Hospital Cancer Care Center
Menomonee Falls Wisconsin, 53051, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon Wisconsin, 53097, United States
Columbia-Saint Mary's Cancer Care Center
Milwaukee Wisconsin, 53211, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Cross Cancer Institute at University of Alberta
Edmonton Alberta, T6G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

65

Study ID:

NCT01082211

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

How clear is this clinincal trial information?

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