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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
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

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


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.

Inclusion 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

Type of Study:

Interventional

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:

Yes

Principal Investigator

Douglas W. Arthur, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Federal Government

Study ID:

RTOG 1014

NCT ID:

NCT01082211

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
Cape Cod HospitalHyannis, Massachusetts  02601
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Flower Hospital Cancer CenterSylvania, Ohio  43560
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
JFK Medical CenterAtlantis, Florida  33462
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Central Maryland Oncology CenterColumbia, Maryland  21044
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Barnes-Jewish West County HospitalSaint Louis, Missouri  63141
Sands Cancer CenterCanandiaqua, New York  14424
University Radiation Oncology at Parkridge HospitalRochester, New York  14626
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
McLaren Cancer InstituteFlint, Michigan  48532
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Tate Cancer Center at Baltimore Washington Medical CenterGlen Burnie, Maryland  21061
Memorial Sloan-Kettering Cancer Center - Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center - Rockville CentreRockville Centre, New York  11570