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ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT


Phase 2
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT


Inclusion Criteria:



1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS

2. Age greater or equal to 50 years old

3. Life expectancy > 6 months

4. Treated by breast conserving surgery with axillary node dissection or sentinel
lymph node biopsy

5. Pathologic tumor size less than or equal to 2 cm

6. Invasive ductal, mucinous, tubular or colloid histology

7. Estrogen receptor positive for invasive carcinoma.

8. Unifocal/unicentric disease

9. Negative surgical margins greater than or equal to 2 mm

10. Pathologic lymph node negative

11. No evidence of lymphovascular invasion

12. ECOG performance status of 0 or 1 (Appendix 1)

13. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)

2. Autoimmune disorder

3. Pregnancy

4. Breast implants

5. Psychiatric or addictive disorder that would preclude attending follow-up

6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)

7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy
proven benign)

8. Lobular features on histology (pure or mixed) or sarcoma histology

9. Node positive on axillary dissection or in the sentinel lymph node biopsy;

10. Extensive in situ carcinoma (EIC)

11. Multicentric or multifocal disease

12. Paget's disease of the nipple

13. Distant metastases

14. Lumpectomy cavity not well visualized on AccuBoost imaging

15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator
(PTV > 6cm)

16. Breast separation with compression > 7cm.

17. Overlap of skin between orthogonal treatment axes.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Early and intermediate toxicity

Outcome Description:

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jaroslaw Hepel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University Oncology Research Group

Authority:

United States: Institutional Review Board

Study ID:

BrUOG 251

NCT ID:

NCT01463007

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • invasive ductal cancer
  • tubular breast cancer
  • breast cancer
  • colloid
  • ER positive
  • radiation
  • Breast Neoplasms

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
Lifespan HospitalsProvidence, Rhode Island  02903
Center For Cancer Care and Research- Watson ClinicLakeland, Florida  33805
The Farber Center for Radiation OncologyNew York, New York  10007
Tacoma RadiationTacoma, Washington