Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer
30 Years
90 Years
Female
Breast Cancer
Trial Information
Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer
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.
Treatment:
Chemotherapy, Hormonal therapy and XRT to the affected breast as per treating institution.
Radiation therapy:
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%.
Follow up:
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.
Inclusion Criteria:
1. Female patient diagnosed with stage I-III breast cancer (AJCC 6), undergoing breast
irradiation as part of her adjuvant therapy.
2. The patient must be a carrier of a deleterious mutation in BRCA 1/2.
3. Age above 30 years.
4. The patient may receive any regimen of adjuvant chemotherapy, according to the
treating physician. All cycles of chemotherapy must be completed at least 3 weeks
prior to the start of radiation therapy.
5. The patient may be treated with hormonal therapy before, during or after study entry,
according to the guidelines of her treating center.
6. The patient must have negative gadolinium based MRI of the contralateral breast, no
more than 6 months prior to study entry.
7. The patient refused prophylactic contralateral mastectomy.
8. The patient is aware that subsequent breast cancer in the irradiated breast will
probably mandate mastectomy.
9. The patient consent for contralateral prophylactic irradiation. -
Exclusion Criteria:
1. Metastatic breast cancer.
2. Previous irradiation of the breast or chest wall.
3. Pregnancy.
4. No concurrent chemotherapy is allowed
5. Patients with active connective tissue diseases are excluded due to the potential
risk of significant radiotherapy toxicity.
6. Patients who are unable to lie on their back and raise their arms above their heads
in the treatment planning position for radiotherapy are excluded -
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Description:
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
Outcome Time Frame:
15 years
Safety Issue:
Yes
Principal Investigator
Ella Evron, MD
Investigator Role:
Study Director
Investigator Affiliation:
Assaf-Harofeh Medical Center
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
102/07 (HT4351)
NCT ID:
NCT00496288
Start Date:
March 2008
Completion Date:
Related Keywords:
- Breast Cancer
- BRCA mutation
- Breast cancer
- Prophylactic breast irradiation
- Prevention of contralateral breast cancer
- Breast Neoplasms
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