Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase III trial studies how well hypofractionated radiation therapy works in
preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter
period of time and may kill more tumor cells that remain after surgery and have fewer side
effects.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- Histologically confirmed invasive carcinoma of the breast of any of the following
histologies (ductal, lobular, mammary, medullary, or tubular); patients with
metaplastic breast cancer are not eligible
- Patients will be staged according to the TNM staging system
- For patients not receiving neoadjuvant chemotherapy, pathologic staging must be
T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status
- For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and
post mastectomy pathological staging is required for all patients; patients who
have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are
only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to
the start of neoadjuvant chemotherapy; cT3N0 patients or ypT3N0 patients who
receive neoadjuvant chemotherapy may be eligible based on clinical or
pathological T stage, and do not require pathologically positive lymph nodes
- Note: Higher of the clinical or pathological T and N stage are used for final
staging, if receiving neoadjuvant chemotherapy; all patients with clinical,
radiographic or pathological T4, N3 or involved internal mammary disease (N1b,
N1c, and N2b) are not eligible. N1mic patients are eligible.
- No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive
oral iodine is permitted
- No prior history of ipsilateral breast cancer (invasive disease or ductal breast
carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease
is allowed
- No history of prior or concurrent contralateral invasive breast cancer; benign breast
disease, LCIS or DCIS of contralateral breast is allowed
- No active collagen vascular diseases, such as: systemic lupus erythematous,
scleroderma, or dermatomyositis
- Negative inked histologic margins from mastectomy pathology (no invasive cells at
margin). Patients with DCIS at margin are eligible.
- No significant post mastectomy complications in the ipsilateral breast requiring an
unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for
margins evaluation, nodal completion and routine reconstruction is acceptable
- Radiation oncologist intends to treat all target volumes and respect all normal
tissues in accordance with the dosimetric constraints described (simulation before
registration recommended)
- Radiation oncologist is planning to treat regional lymph nodes including internal
mammary nodes and meet acceptable protocol dosimetric requirements
- Radiation oncologist is NOT planning to utilize a chest wall/scar boost
- Patient must have undergone immediate reconstruction at the time of mastectomy or be
planning to undergo reconstruction within 18 months after radiation
- Treating physician and patient must plan to start radiation treatment within the
timeframes specified in protocol.
- If a tissue expander is utilized it needs to be a fluid filled expander, NO air
expander (unless completely deflated) during radiation therapy
- For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days
prior to registration
- No co-existing medical conditions with life expectancy < 5 years
- No other malignancy within 5 years of registration with the exception of basal cell or
squamous cell carcinoma of the skin treated with local resection only or carcinoma in
situ of the cervix
- Negative pregnancy test (serum or urine HCG) in women of child-bearing potential ≤ 7
days prior to registration. Patients who have received a bilateral tubal ligation
still require a negative pregnancy test for eligibility. A female of childbearing
potential is a sexually mature female who has not undergone a hysterectomy or
bilateral oophorectomy and has not been naturally postmenopausal for at least 12
consecutive months
- Women of child-bearing potential must agree to utilize a form of birth control or
agree to undergo sexual abstinence during radiation therapy
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- Patients must be able to read and comprehend English, in order to be able to complete
study questionnaires; however, patients participating through Canadian Cancer Trials
Group (CCTG) institutions who can read and comprehend French are eligible