Know Cancer

or
forgot password

Short-term Evaluations of Breast Tissue Change in Post-menopausal Women Using Optical Breast Spectroscopy (OBS)


N/A
30 Years
65 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Short-term Evaluations of Breast Tissue Change in Post-menopausal Women Using Optical Breast Spectroscopy (OBS)


Hormone Replacement Therapy (HRT) provides many benefits to post-menopausal women, which
have been overshadowed by an increase in breast cancer in women following HRT, resulting in
a negative HRT cost-benefit ratio. Epidemiological studies show evidence of a direct
association between HRT use and breast cancer incidence. This increase in incidence was also
reflected in an increase of the mammographic breast density (MBD). Endogenous MBD is a well
established risk factor for breast cancer which provides a high odds ratio (OR 4 - 6)
towards breast cancer. Increases in MBD have been reported in women who initiate HRT, which
is of concern as it potentially indicates a greater adverse effect of HRT on those
individuals. In these cases, the majority of the incremental MBD increase manifests itself
during the first year of use and decreases in the case of therapy cessation. The ability to
detect changes in MBD in women commencing HRT treatment, without the ionizing radiation dose
penalty imparted by mammography, thus permitting improved monitoring of MBD changes de to
HRT, would certainly impact the debate on the applicability of HRT. Women identified as
having increased MBD induced by HRT should discontinue its use or modify the prescription as
increases in MBD potentially indicates an adverse ratio; women whose MBD has not been
adversely affected by HRT can continue its use and reap the benefits of HRT (e.g. relief of
climacteric symptoms, beneficial effects against osteoporosis and coronary heart disease).

Optical Breast Spectroscopy (OBS) is a safe and non-invasive optical technique that provides
information on breast tissue composition and physiology state. Comparison of breast tissue
status over time will provide information on changes in the MBD and breast cancer risk due
to interventions such as HRT. To demonstrate that breast tissue status changes with HRT use,
we will exploit existing algorithms correlating OBS with various biological outcomes. A
completed study on a cohort of 300 healthy women (age 38 to 72) showed a high correlation
between OBS optical parameters and Cumulus derived MBD. An ongoing study, to be completed Q3
2008 with an interim analysis available, suggests that OBS parameters can optically detect
differences between the contralateral breasts of women with a unilateral carcinoma or ductal
carcinoma in situ (DCIS) and healthy controls. Through these studies, two OBS algorithms
("density" and "risk") are available for application in the proposed study. The algorithms
take OBS optical data as input and output OBS-derived percent breast density (PBD) and
OBS-derived risk values. The aim of the study is to examine changes in OBS-derived PBD and
OBS-derived risk values due to the initiation, use and cessation of HRT over a 1 year
period. The case group will comprise a population of post-menopausal women who have elected
to undergo a HRT regiment designed to last at least 1 year but had no prior HRT treatment.
The comparison group (control) will comprise of post-menopausal women not on HRT and had no
prior HRT treatment. OBS measurements will be assessed at intervals corresponding to:
baseline (pre-HRT), 1 month, 3 months, 6 months, and 1 year after initiation of HRT use, and
3 months after cessation of treatment (in cases where HRT is discontinued within one year).
Blood will be collected at baseline and at 3 months during treatment to examine changes in
circulating hormones (estrogen, progesterone). Mammography will be performed at three months
during treatment and compared to a screening mammogram (taken within a year prior to HRT
treatment) to determine changes in breast density. A Papanicolaou test (or PAP smear) will
be performed at baseline to assess endometrial changes. Changes in OBS derived PBD and MBD
as well as other pertinent risk values will be examined as a function of time.

Four model groups will be monitored consisting of cases receiving treatments of Premarin,
Premarin + Provera combination, or Premarin + Prometrium combination and controls not on
HRT. A total of 20 women will be recruited into each group of the four groups. While the
total number of women intended for recruitment is small, they are sufficient to enable us to
demonstrate that OBS changes as function of MBD changes. Of further interest, we want to
determine whether OBS can detect changes prior to changes to MBD in standard clinical
setting. In particular, we aim to determine the magnitude of the effect size and the
variance within the study groups for later initiation of a larger definitive clinical
monitoring trail of HRT effects by OBS.

The long term clinical goal is the identification of women adversely affected by HRT by OBS
as they can be advised of alternative methods with possible lower risk to benefit ratio to
relieve climacteric symptoms. An overall effect will be a reduction in the population-based
incidence of breast cancer while not withholding the beneficial effects of HRT to the
majority of women during menopause.


Cases

Inclusion Criteria:



- Post-menopausal

- Attending the Endocrinology clinic at SMH

- Will start HRT treatment

Exclusion Criteria:

- Current or Past HRT treatment

- Prior breast cancer

- Benign breast disease

- Bilateral breast biopsy

- Fine needle aspiration (FNA) within a year

- Cosmetic alteration (reduction/augmentation)

- Gynecological surgery

- Past or current chemo- therapeutic or prevention treatment

Controls

Inclusion Criteria:



- Not on HRT treatment

Exclusion Criteria:

- Current or Past HRT treatment

- Prior breast cancer

- Benign breast disease

- Bilateral breast biopsy

- Fine needle aspiration (FNA) within a year

- Cosmetic alteration (reduction/augmentation)

- Gynecological surgery

- Past or current chemo- therapeutic or prevention treatment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes in OBS parameters

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Lothar Lilge, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9

Authority:

Canada: Health Canada

Study ID:

TiBS-HRT

NCT ID:

NCT00797199

Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer Risk
  • Hormone Replacement Therapy
  • Optical Transillumination Spectroscopy
  • Optical Breast Spectroscopy
  • Transillumination Breast Spectroscopy
  • Breast Neoplasms

Name

Location