Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy in Treating Women With Early Stage Breast Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that re...
Detailed Description
OBJECTIVES: Primary * To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy. * To determine the acu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer, including 1 of the following subtypes:
- Ductal carcinoma in situ
- Invasive ductal carcinoma
- Invasive lobular carcinoma
- Medullary carcinoma
- Papillary carcinoma
- Colloidal (mucinous) carcinoma
- Tubular carcinoma
- Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
- Tumor size ≤ 5 cm
- Breast considered technically satisfactory for radiotherapy
- Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
- Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
- Unifocal or multifocal (confined to 1 quadrant; tumors \< 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
- No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
- If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
- No more than 9 positive axillary lymph nodes
- No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
- No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
- No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
- No Paget disease of the nipple
- No skin involvement, regardless of tumor size
- No distant metastases
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Pre- or post-menopausal
- ECOG performance status 0-1
- No co-existing medical condition that would limit life expectancy to \< 2 years
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
- No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No psychiatric or addictive disorder that would preclude obtaining informed consent
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy for the current breast cancer
- No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
- Chemotherapy allowed provided the following criteria are met:
- Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
- Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
- Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
- May be initiated before, during, or after radiotherapy
- No other concurrent chemotherapy, immunotherapy, or experimental medications
Exclusion
Key Trial Info
Start Date :
May 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00909909
Start Date
May 13 2009
End Date
July 1 2027
Last Update
August 3 2023
Active Locations (4)
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1
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, United States, 08690
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08690
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
4
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States, 08873