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Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Ductal Breast Cancer

Thank you

Trial Information

Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study


- In this study, radiotherapy is given only to a portion of the breast around the tumor
bed using external radiation treatments. This approach is called "partial breast
irradiation".

- Participants will undergo a planning session for the radiation treatments. This
planning will be done by CT scan days or weeks before the start of treatment. This
planning process is the same as that used to plan conventional radiation therapy
treatments.

- Radiation therapy will begin 4-12 weeks after the last surgery of the breast in
individuals not receiving chemotherapy first. For individuals receiving chemotherapy
before radiation therapy, radiation therapy will start 2-6 weeks after ending
chemotherapy.

- We will be studying three levels of radiation doses to see which is best. The dose the
participant receives will depend upon when they are enrolled on the trial.

- Participants will receive radiation treatment twice each day for 4 or 5 treatment days,
with an overall treatment time of one week.


Inclusion Criteria:



- Histologically confirmed unicentric Stage I Invasive Ductal breast cancer.
Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in
re-excision specimen or final shaved specimen.

- Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal
therapy or begin hormonal therapy following XRT

- 18 years of age or older

- ECOG Performance Status 0

- Required laboratory data as outlined in the protocol

Exclusion Criteria:

- Multicentric IDC of the breast defined as discontiguous tumors separated by at least
5cm of uninvolved tissue

- Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive
carcinoma, separated by uninvolved intervening tissue, but within an overall span of
5cm, or within the same breast quadrant or subareolar central region

- Tumor > 2.0cm, nodal involvement, or metastatic involvement

- Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive
intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed
ductal and lobular type; DCIS with microinvasion and DCIS suspicious for
microinvasion; infiltrating micropapillary carcinoma

- Known mutation carrier, including BRCA1 and BRCA2

- History of cosmetic or reconstructive breast surgery

- Psychiatric illness which would prevent the patient from giving informed consent

- Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or
connective tissue disease

- Participants with a "currently active" second malignancy other than non-melanoma skin
cancers

- Patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications

- Women who are pregnant

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility of PBI directed XRT in selected stages 0 and 1 female breast cancer patients within each dose level.

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Alphonse Taghian, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

03-179

NCT ID:

NCT00694577

Start Date:

September 2003

Completion Date:

September 2019

Related Keywords:

  • Ductal Breast Cancer
  • non-invasive breast cancer
  • early invasive breast cancer
  • radiation
  • PBI
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Boston Medical CenterBoston, Massachusetts  02118
Massachusetts General HospitalBoston, Massachusetts  02114-2617