Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00496288|
Recruitment Status : Recruiting
First Posted : July 4, 2007
Last Update Posted : April 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Prophylactic radiation to the contralateral breast||Phase 2|
Trial design and statistics:
This is a multi center- phase II open comparative trial. "Patients" - Those who choose prophylactic contralateral breast irradiation. "Controls" - Those that do not opt for prophylactic irradiation or mastectomy. Objective - to compare the rate of contralateral breast cancer in "patients" versus "controls".
Assuming that 2/3 of the eligible carrier breast cancer patients refuse the procedure: To detect a difference of 10% vs. 25% in the incidence of contralateral breast cancer with power = 80%, alpha = 0.05, 80 patients and 160 controls need to be enrolled.
Chemotherapy, Hormonal therapy and XRT to the affected breast as per treating institution.
Patients will undergo a pre-treatment planning CT with 5mm cuts in the treatment position, on a breast board, with both arms extended above their head. The organs at risk (heart, lungs) will be contoured on the CT scan.
The affected breast (with the index lesion) and associated lymphatic drainage will be treated according to the treating physician decision. The contralateral breast will be treated with 2 tangent fields, using 1.8-2 Gy/fx to a total dose of 50-50.4 Gy. The whole breast will be treated according to traditional guidelines and as described in the RTOG/NSABP B39 study. The heart should be completely blocked for left sided breasts, included lung tissue should be reduced to minimum. No overlapping field is allowed on the skin between the two breast fields in the midline. Maximal dose should not exceed 110%.
The treating physician will follow the patient every 2 weeks during the radiation treatment. Side effects will be scored and recorded in the patients chart according to the Common Terminology Criteria for Adverse Events v3.0.
Subsequent follow-up schedule according to the treating institution and ASCO guidelines. Patients will undergo annual mammogram and breasts US. Annual breasts MRI and bilateral salpingo-oophorectomy will be recommended.
Ipsilateral and contralateral breast cancer will be recorded and reported. Any subsequent malignancy other than breast cancer will be reported. Long-term radiation side effects will be recorded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||March 2023|
Experimental: prophylactic irradiation
prophylactic contralateral breast irradiation
Radiation: Prophylactic radiation to the contralateral breast
The contralateral breast will be treated with 2 tangent fields, using 1.8-2 Gy/fx to a total dose of 50-50.4 Gy. The whole breast will be treated according to traditional guidelines and as described in the RTOG/NSABP B39 study. The heart should be maximally blocked for left sided breasts, included lung tissue should be reduced to minimum. No overlapping field is allowed on the skin between the two breast fields in the midline. Maximal dose should not exceed 110%
No Intervention: controls
Those that do not opt for prophylactic irradiation or mastectomy
- Rate of contralateral breast cancer in carrier patients that received prophylactic radiation to the contralateral breast compared with carrier patients that did not receive that treatment. [ Time Frame: 15 years ]To compare the rate of contralateral breast cancer in carrier patients that received prophylactic radiation to the contralateral breast to the rate in carrier patients that did not receive that treatment
- Short and long term adverse effects of prophylactic contralateral breast irradiation. [ Time Frame: 15 years ]
- factors that influence patient's choice of treatment [ Time Frame: 15 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496288
|Contact: Ella Evron, MDemail@example.com|
|Assaf-Harofeh Medical Center||Recruiting|
|Zerrifin, Israel, 70300|
|Contact: Ella Evron, MD 97289778144 firstname.lastname@example.org|
|Principal Investigator: Ella Evron, MD|
|Study Director:||Ella Evron, MD||Assaf-Harofeh Medical Center|