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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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