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

March 5, 2010
June 25, 2013
June 2010
December 2014   (final data collection date for primary outcome measure)
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 ]
Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01082211 on ClinicalTrials.gov Archive Site
  • 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 ]
  • In-breast recurrence [ Designated as safety issue: No ]
  • Freedom from mastectomy [ Designated as safety issue: No ]
  • Rate of circulating tumor cells [ Designated as safety issue: No ]
  • Overall and 1-year adverse events [ Designated as safety issue: Yes ]
  • Cosmesis at 1 and 3 years [ Designated as safety issue: No ]
  • Distant metastasis-free survival [ Designated as safety issue: No ]
  • Mastectomy-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: Partial Breast Re-Irradiation
Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 GY x 15 (BID) to 45 Gy Total
Interventions:
  • Other: circulating tumor cell analysis
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Procedure: adjuvant therapy
  • Radiation: 3-dimensional conformal accelerated partial breast irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01082211
RTOG 1014, CDR0000666991
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Douglas W. Arthur, MD Massey Cancer Center
Radiation Therapy Oncology Group
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP