CompletedNot Applicable

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

United States13 participantsStarted 2008-09-23

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer. PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies. * Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost) * Unifocal breast cancer recurrence * Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision * Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation. * Signed study-specific informed consent prior to study entry. Exclusion Criteria: * Patients with distant metastatic disease * Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma. * Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative. * Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast…

What they're measuring

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 1 month after radiation therapy (RT)

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 3 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 6 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 9 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 12 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 2 years after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 3 years after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 4 years after RT

Trial details

NCT IDNCT00945061

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-06

Results submitted2020-07-15

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 1 month after radiation therapy (RT)

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 3 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 6 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 9 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 12 months after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 2 years after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 3 years after RT

Ipsilateral Breast Tumor Recurrence Rates

Timeframe: 4 years after RT