Radiation Therapy in Treating Women With Early Stage Breast Cancer (NCT00909909) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Radiation Therapy in Treating Women With Early Stage Breast Cancer
United States200 participantsStarted 2009-05-13
Plain-language 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 remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
Who can participate
Age range18 Years – 120 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
Timeframe: 5 years
Trial details
NCT IDNCT00909909
SponsorRutgers, The State University of New Jersey