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Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer


Phase 2
55 Years
N/A
Open (Enrolling)
Both
Early-Stage Breast Cancer

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Trial Information

Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer


- Patients will have undergone conservative breast surgery without axillary dissection
prior to enrollment in this study.

- Patients will receive radiation therapy to the breast, including the lowest axillary
lymph nodes, over a period of 6 1/2 weeks.

- No radiation will be specifically directed toward the upper axilla or supraclavicular
lymph nodes.

- Patients will also receive 5 years of tamoxifen or another type of hormone therapy
determined by the medical oncologist.

- Follow-up visits will occur every 6 months and mammograms every 12 months.


Inclusion Criteria:



- Patients must have clinical stage I or II breast cancer, clinically uninvolved
axillary nodes.

- Patients must be 55 years or older.

- Patients must undergo total excision of the primary invasive tumor

- Final pathologic margin status must be negative

- Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be
permitted

Exclusion Criteria:

- Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in
situ fo the cervix

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Julia S. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

98-101

NCT ID:

NCT00165243

Start Date:

September 1998

Completion Date:

December 2016

Related Keywords:

  • Early-Stage Breast Cancer
  • Axillary Dissection
  • Tangential Radiation
  • Breast Cancer
  • Breast Neoplasms

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617