"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"
Each of the criteria in the following section must be met in order for a patient to be
considered eligible for registration.
- Patient must be older than 18 years of age
- Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma
of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes
(pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or
sarcomas of the breast cancer are NOT eligible.
- Patient must have a history and physical within six weeks prior to the start of any
- Patient must have had a bilateral mammogram prior to surgery.
- Patients must have undergone a segmental mastectomy (SM) with a level I and ll
axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM
must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive
ductal carcinoma. Patients who have post-operative margins which are negative but
less than 2mm will be considered eligible if the surgeon states that the margin in
question could not be improved.
- Patient must have a Medical Oncology consult and be recommended to receive one of the
following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and
Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin
and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy,
hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the
- Patients must be registered such that radiation therapy begins no sooner than 7 days
prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start
chemotherapy and radiation less than 14 weeks from the last breast surgical
- Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the
- Patients must have a performance status 0 or 1 by ECOG criteria
- Patients must not have received prior radiation therapy to the involved breast at any
time for any reason.
- Any patient with active local-regional disease prior to registration is not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or any other cancer from which
the patient has been disease-free for 5 years.
- Patients must not be pregnant due to the potential for fetal harm as a result of this
treatment regimen. Women of child-bearing potential must use effective non hormonal
contraception while undergoing radiation therapy. Women of child-bearing potential
must also have a negative pregnancy test within six weeks prior to start of protocol
- Patients must not have a serious medical or psychiatric illness which prevents
informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and given
written informed consent in accordance with institutional and federal guidelines.