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A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

After signing the consent form, the following will be assessed.

-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This
is referred to as a CT-simulation. This scan is done routinely as part of the regular

PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over
a 2 week period. During this time you will have a weekly interview, physical examination,
and your skin will be assessed for any side effects of the radiation.

PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after
chemotherapy (if you have been given chemotherapy).

After the final dose of the study:

You will have the following scheduled follow-up visits: one at the completion of the
radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6
months for five years, and then once every year for the following five years after the
completion of radiation therapy.

Inclusion Criteria:

- Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less
than or equal to 2cm on pathology and/or mammography

- Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor
in a re-excision specimen or final shaved specimen

- Clips must be placed in the lumpectomy cavity at the time of final excision in order
to aid in the delineation of the tumor cavity at the time of simulation and radiation

Exclusion Criteria:

- No distant metastasis

- Not pregnant or breastfeeding

- No diffuse suspicious microcalcifications

- No prior radiation therapy to the ipsilateral or contralateral breast or thorax

- No histologic evidence of lymphovascular invasion (LVI)

- No histologic evidence of EIC

- No history of cosmetic or reconstructive breast surgery

- No psychiatric illness that would prevent the patient from giving informed consent

- No medical conditions that, in the opinion of the treating physician would make this
protocol unreasonably hazardous for the patient

- No other currently active second malignancy other than non-melanoma skin cancers

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of external-beam PBI utilizing 40Gy in ten daily fractions over two weeks

Outcome Description:

To evaluate the safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. The development of clinical fat necrosis. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.

Outcome Time Frame:

2 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Early Invasive N0
  • Non-Invasive
  • Breast Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Beth Isreal Deaconness Medical CenterBoston, Massachusetts  02115
Brigham and Women's HosptialBoston, Massachusetts  02215