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Phase 2 N=65 Treatment

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

Breast Cancer

Enrolled (actual)
65
Serious AEs
5.2%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events — 1 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
3D-Conformal External Beam (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Radiation Therapy Oncology Group
Primary completion
Nov 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events
1
SECONDARY
In-breast Recurrence
3.7 0.0002 sig
SECONDARY
Freedom From Mastectomy
5.2
SECONDARY
Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)
8; 32; 7; 8; 26; 13
SECONDARY
Treatment-related Adverse Events (AEs) Any Time
0; 0; 10.3; 32.8; 41.4
SECONDARY
Distant Metastasis-free Survival
94.8
SECONDARY
Mastectomy-free Survival
89.7
SECONDARY
Overall Survival
94.8
SECONDARY
Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation
0; 0; 6.9; 22.4; 24.1
SECONDARY
Change in Patient-Reported Cosmetic Outcomes From Baseline to 12-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
0.04; 0.09; -0.21
SECONDARY
Change in Patient-Reported Cosmetic Outcomes From Baseline to 36-Months as Measured by the Breast Cancer Treatment Outcome Scale (BCTOS)
-0.02; 0.19; -0.20
SECONDARY
Number of Patients With Good/Excellent Cosmesis Using the NRG Oncology/Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale
26; 22; 14
SECONDARY
12-Month BCTOS Mean Subscale Scores by 12-Month NRG Oncology/RTOG Cosmetic Rating Scale
1.03; 1.67; 1.33; 1.14; 1.88; 1.53 0.054

Summary

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.

Eligibility 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
  • 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
  • Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
  • Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
  • 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
  • For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01082211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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