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Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer

18 Years
50 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer

Inclusion Criteria:

- Diagnosis of invasive breast cancer or DCIS

- Appropriate for genetic testing, defined as if they meeting one or more of the
following criteria (note that patients may be appropriate for genetic testing even if
they do not meet these criteria, but NCCN and most payers recognize these groups as
clearly appropriate for testing)

- Must be a primary malignancy (not recurrence), but can be second diagnosis if is a
contralateral cancer and the first cancer was not treated with mastectomy

- Female age ≥18,

- If Ashkenazi Jewish: Breast cancer diagnosis ≤ 60. Subjects will be presumed to be of
Ashkenazi ethnicity if Jewish religious preference is confirmed in subject and at
least 1 parent, unless they explicitly endorse Sephardic, Iranian, Yemeni/Ethiopian,
or Bukharan Jewish Decent, in which case non-Ashkenazi criteria will be applied.

If not Ashkenazi Jewish:

- Breast cancer diagnosis ≤ 45 OR

- Bilateral breast cancer, with first diagnosed ≤ 50 OR

- Breast cancer diagnosed at any age with a male relative with breast cancer OR

- Breast cancer diagnosis ≤ 50 with one or more of the following::

- 1 or more relative with breast cancer ≤ 50 or

- 1 or more relative with ovarian cancer

- Have not completed definitive surgical treatment

- For patients planning mastectomy for treatment, has not yet undergone mastectomy

- For patients planning breast conservation for treatment, has not yet begun adjuvant
radiation therapy

Exclusion Criteria:

- LCIS without invasive cancer (IDC or ILC) and without DCIS

- Previous breast cancer treated with mastectomy

- Plan for neoadjuvant chemotherapy before surgery

- Unable to complete English language questionnaires, as instruments have not been
validated in non-English speaking populations

Type of Study:


Study Design:

Observational Model: Family-Based, Time Perspective: Prospective

Outcome Measure:

To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing

Outcome Description:

Either before completing definitive local surgical treatment (pre-surgical testing), after definitive surgical treatment (post-surgical) Women will be evaluated for their levels of general and cancer specific distress, coping style, and stage of decision-making with respect to PM (as this is the primary clinical reason for undergoing immediate testing).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mark Robson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Genetic testing
  • BRCA testing
  • Ashkenazi descent
  • 11-086
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021