Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 correlative studies

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory)

On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) (patients with mixed DCIS and lobular carcinoma in situ \[LCIS\] are eligible)

The DCIS must be HER2-positive as determined by central testing

Estrogen and/or progesterone receptor status must be determined prior to randomization (patients with DCIS that is hormone receptor positive or negative are eligible)

All DCIS must have been resected by lumpectomy

Contralateral breast cancer (including DCIS)

Whole breast irradiation administered before randomization (partial breast irradiation is prohibited)

Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible)

Prior anthracycline chemotherapy for any malignancy

Cardiac disease that would preclude the use of the drugs included in the B-43 treatment regimens; this includes but is not confined to:

* Active cardiac disease:

* Angina pectoris that requires the use of anti-anginal medication;

* Ventricular arrhythmias except for benign premature ventricular contractions (PVCs) controlled by medication;

* Conduction abnormality requiring a pacemaker;

* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and

* Clinically significant valvular disease

* History of cardiac disease:

* Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;

* Documented congestive heart failure; or

* Documented cardiomyopathy

Uncontrolled hypertension, i.e., systolic blood pressure \[BP\] greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg (patients with hypertension that is well controlled on medication are eligible)

Other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiation therapy or would prevent prolonged follow-up

Pregnancy or lactation at the time of study entry (note: pregnancy testing according to institutional standards should be performed for women of child-bearing potential)

Administration of any investigational agent within 30 days before study entry

What this study is about