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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01082211
First received: March 5, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: circulating tumor cell analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal accelerated partial breast irradiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events [ Time Frame: From the end of radiation to 1 year. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • In-breast recurrence [ Time Frame: From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
  • Freedom from mastectomy [ Time Frame: From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
  • Rate of circulating tumor cells [ Time Frame: Prior to the start of radiation and 3 weeks after last radiation treatment. ] [ Designated as safety issue: No ]
  • All treatment-related adverse events [ Time Frame: After 1 year from the end of radiation and from the end of radiation to end of follow-up. ] [ Designated as safety issue: Yes ]
  • Cosmesis [ Time Frame: After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Time Frame: From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potientially followed for 3 years. ] [ Designated as safety issue: No ]
  • Mastectomy-free survival [ Time Frame: From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years. ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Partial Breast Re-Irradiation
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 GY x 15 (BID) to 45 Gy Total
Other: circulating tumor cell analysis Other: laboratory biomarker analysis Other: questionnaire administration Procedure: adjuvant therapy Radiation: 3-dimensional conformal accelerated partial breast irradiation

Detailed 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 at 1 year and at any time of this regimen in these patients.
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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 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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082211

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381
United States, California
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Maryland
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Tate Cancer Center at Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
McLaren Cancer Institute
Flint, Michigan, United States, 48532
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
United States, Missouri
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Memorial Sloan-Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States, 07920
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Sands Cancer Center
Canandiaqua, New York, United States, 14424
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
University Radiation Oncology at Parkridge Hospital
Rochester, New York, United States, 14626
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Columbia-Saint Mary's Cancer Care Center
Milwaukee, Wisconsin, United States, 53211
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Douglas W. Arthur, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01082211     History of Changes
Other Study ID Numbers: RTOG 1014, CDR0000666991
Study First Received: March 5, 2010
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014