CTSU NCIC MA.27D

KCCOP Protocol Summary

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full protocol.
Members may follow the "Full Protocol" link or contact KCCOP for complete protocol information.

Full Protocol

(members only)

Consent Form

HIPAA

Spanish Consent Form

CTSU NCIC MA.27D - "The Association of Breast Density Changes, Plasma Hormone Changes and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27"

Treatment Plan (Supplied Drug: N/A)

Enrollment to MA.27 core protocol

Enroll pts who are eligible for Breast Density companion study

Blood sample collected at baseline w/main blood draw (1 tube - mail w/blood samples from parent protocol, MA.27)
Pt Questionnaire

Follow-up for 1 yr period

At 1 yr follow-up visit

Blood draw (bank blood including plasma & buffy coat for correlative studies (blood kits, 3 tubes)
Pt Questionnaire

Obtain, digitize, & estimate breast density on pre-tx mammogram, and mammograms closest to 1 & 2 yrs of therapy

Eligibility

Postmenopausal women w/receptor positive breast cancer.
1 intact, non-cancerous breast w/no hx of previous breast surgery in that breast (other than breast bx).
Mammogram of intact, non-cancerous breast <12 mos pre-regist. Both crandiocaudal (top down) and mediolateral oblique view (side view) must be available.
Provide consent to retrieve and digitize orig mammograms taken pre-regist and mammograms closest to 1 & 2 yrs post-regist.
Can provide location where pre-regist, yr 1, & yr 2 mammograms for parent protocol MA.27 are performed.
Agree to additional blood banking specimen drawn at same time as pre-tx specimens are drawn on MA.27. Agree to have blood sample taken at 12 mos post-regist on MA.27D.
No HRT, oral contraceptives, Tamoxifen, Raloxifene, other SERMs, or GnRHAs taken <6 mos prior to pre-regist mammogram.
No prescription &/or utilization of HRT, oral contraceptives, Tamoxifen, Raloxifene, other SERMs, or GnRHAs <6 mos prior to pre-regist mammogram.
PRESTUDY REQUIREMENTS (<14 days after obtaining consent):
- Pt questionnaires (hard copy booklets must be used, not photocopies - contact KCCOP)
- Blood sample* (must be done w/blood banking for MA.27 core protocol)
- Orig mammogram (taken <12 mos pre-regist)
* Draw blood in 10mL sodium heparin tube. Use kit provided for MA.27 core protocol blood banking component (has an extra mailing slot). Must be drawn b/f tx begins.
Signed informed consent.