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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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 at 1 year and at any time of this regimen in these

- 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

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

Inclusion Criteria


- 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

- Initial lumpectomy followed by whole-breast radiotherapy performed over 1 year ago

- Repeat lumpectomy performed within the past 42 days

- 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

- Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence
within the past 120 days and the following must be true:

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

- Negative histologic margins of resection and no tumor on ink following
breast-preserving surgery

- Re-excision to achieve negative margins allowed

- 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

- 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

- 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

- 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

- 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

- No more than 120 days since whole-body 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

- 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

- No psychiatric or addictive disorders that would preclude obtaining informed consent


- See Disease Characteristics

- More than 2 weeks since prior chemotherapy and recovered

- No concurrent intensity-modulated radiotherapy

- No concurrent chemotherapeutic agents, including trastuzumab

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events

Outcome Time Frame:

From the end of radiation to 1 year.

Safety Issue:


Principal Investigator

Douglas W. Arthur, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Federal Government

Study ID:

RTOG 1014



Start Date:

June 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • invasive ductal breast carcinoma
  • medullary ductal breast carcinoma with lymphocytic infiltrate
  • invasive lobular breast carcinoma
  • tubular ductal breast carcinoma
  • mucinous ductal breast carcinoma
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • recurrent breast cancer
  • Breast Neoplasms



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University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Rapid City Regional Hospital Rapid City, South Dakota  57709
Cape Cod Hospital Hyannis, Massachusetts  02601
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Monmouth Medical Center Long Branch, New Jersey  07740-6395
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
St. Barnabas Medical Center Cancer Center Livingston, New Jersey  07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
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Highland Hospital of Rochester Rochester, New York  14620
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
Flower Hospital Cancer Center Sylvania, Ohio  43560
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Community Memorial Hospital Cancer Care Center Menomonee Falls, Wisconsin  53051
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
JFK Medical Center Atlantis, Florida  33462
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Central Maryland Oncology Center Columbia, Maryland  21044
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St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Barnes-Jewish West County Hospital Saint Louis, Missouri  63141
Sands Cancer Center Canandiaqua, New York  14424
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Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank, California  91505
Arizona Center for Cancer Care - Peoria Peoria, Arizona  85381
McLaren Cancer Institute Flint, Michigan  48532
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Tate Cancer Center at Baltimore Washington Medical Center Glen Burnie, Maryland  21061
Memorial Sloan-Kettering Cancer Center - Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville Centre Rockville Centre, New York  11570