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

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Trial Information


Inclusion Criteria:



- Female aged 60 years or older.

- Invasive ductal carcinoma.

- Unifocal disease.

- Tumors less than 2cm.

- No clinical evidence of nodal disease.

- Estrogen receptor status (ER) positive.

- Her2 negative.

Exclusion Criteria:

- Age less than 60 years.

- BRCA 1 and/or BRCA 2 mutation.

- Tumour histology limited to lobular carcinoma only.

- Neoadjuvant hormonal manipulation or chemotherapy.

- More than one primary tumour in different quadrants of the same breast.

- Inability to view tumor on imaging.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Acute toxicity

Outcome Description:

Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Michael Yassa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Maisonneuve-Rosemon Hospital

Authority:

Canada: Institutional Review Board

Study ID:

12030

NCT ID:

NCT01717261

Start Date:

August 2012

Completion Date:

May 2019

Related Keywords:

  • Breast Cancer
  • breast cancer
  • early breast cancer
  • partial breast irradiation
  • preoperative radiation
  • Breast Neoplasms

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