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A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

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Trial Conditions
  • Breast Cancer
  • Ductal Breast Carcinoma in Situ
  • HER2/Neu Positive
What is the purpose of this trial?

This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Inclusion Criteria:

- 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

- All DCIS must have been resected by lumpectomy

- The margins of the resected specimen must be histologically free of DCIS; for
patients in whom pathologic examination demonstrates DCIS present at the line of
resection, re-excision(s) may be performed to obtain clear margins (patients who
require mastectomy are not eligible)

- If axillary staging is performed, nodal staging must be pN0, pN0(i-), pN0(i+) which
is defined as isolated tumor cells =< 0.2 mm, regardless of the method of detection,
i.e., immunohistochemistry (IHC) or hematoxylin & eosin (H&E), pN0(mol-), or
pN0(mol+); note: axillary staging is not required

- The interval between the last surgery for excision of DCIS (lumpectomy or re-excision
of lumpectomy margins) and randomization must be no more than 120 days

Exclusion Criteria:

- Invasive (including microinvasion staged as T1mic) breast cancer (patients with DCIS
"suspicious" for microinvasion, but not confirmed, are eligible)

- Nodal staging of pN1 (including pN1mi) (note: axillary staging is not required)

- DCIS present in more than one quadrant (multicentric)

- Masses or clusters of calcification that are clinically or mammographically
suspicious unless biopsied and proven to be benign (if DCIS is found, the patient is
eligible if the DCIS was in the same quadrant of the ipsilateral breast and was
resected with clear margins)

- 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

- 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)

- 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

- Other malignancies unless the patient is considered to be disease-free for 5 or more
years prior to randomization and is deemed by her physician to be at low risk for
recurrence; patients with the following cancers are eligible if diagnosed and treated
within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the
colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin

- 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

Gender: Female
Steward Physician(s)
  • Melody Cobleigh
  • Douglas W. Arthur, MD
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
  • Trastuzumab
  • Laboratory Biomarker Analysis
  • Whole Breast Irradiation
Physician Researcher

Investigator Name:

  • Melody Cobleigh
  • Douglas W. Arthur, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00769379
Volunteers:  Not Accepting Healthy Volunteers

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