Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
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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: | 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 |
- Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year [ Designated as safety issue: Yes ]
- 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 ]
| Estimated Enrollment: | 61 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
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 |
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
- 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
Show 58 Study Locations| Principal Investigator: | Douglas W. Arthur, MD | Massey Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01082211 History of Changes |
| Other Study ID Numbers: | CDR0000666991, RTOG-1014 |
| Study First Received: | March 5, 2010 |
| Last Updated: | September 16, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 May 23, 2013