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Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Pilot Study

25 Years
56 Years
Not Enrolling
Breast Cancer, Healthy, Ovarian Cancer

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Trial Information

Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Pilot Study

Asymptomatic, premenopausal women are (1) known carriers of an altered BRCA1 or BRCA2 gene,
or (2) first- or second-degree relatives of individuals with a BRCA-associated cancer in a
family documented to have a BRCA1 or BRCA2 gene mutation will be eligible for inclusion in
this pilot study to assess new approaches to early detection of breast and ovarian cancer in
high-risk women. We will recruit up to fifty women (twenty-five women who carry an altered
BRCA1 or BRCA2 gene and 25 non-carriers matched by age and family mutation type) with
regular menstrual cycling (documented by menstrual history and premenopausal FSH level). A
physical exam including exam of the breast and pelvis, a standard four view mammogram and
breast MRI will be scheduled initially during either the follicular or mid-luteal phase of
the menstrual cycle. A unilateral cranio-caudal mammogram and bilateral MRI will be
repeated three months after entry during the phase not initially studied. A CA125 and
transvaginal color doppler ultrasonography will be done in the follicular phase. Carriers
and non-carriers will be compared with respect to menstrual cycle differences in: (1) two
measures of mammographic density (qualitative and semiquantitative); (2) a semiquantitative
measure of fibroglandular volume (MRI); and (3) a semiquantitative measure of contrast
enhancement (MRI). On the initial and three-month visit, all participants will undergo
breast duct lavage to investigate if there are consistent menstrual cycle differences in
breast ductal cytologies. Participants will be seen annually thereafter for an additional
three years of follow-up. A physical exam, standard four-view mammography, breast MRI, CA
125, transvaginal color doppler ultrasonography and breast duct lavage will be done

Participants in the Menstrual Cycle Pilot Study, will complete a self-administered
questionnaire and telephone interview and will complete periodic follow-up questionnaires to
assess various behavioral and psychosocial endpoints.

As part of the Menstrual Cycle Pilot Study, we will recruit 25 volunteers to assist in
training study investigators in performing breast duct lavage. Cytologies obtained from
volunteers will be used to develop oncogene probe panels to be used in the study.

Inclusion Criteria


Inclusion Criteria - Menstrual Cycle Study:

To participate in the Menstrual Cycle Pilot Study, a woman must:

Must be at least 25 years of age (or 5 years younger than the age at diagnosis of the
youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome)
and less than 46 years of age.

Must be premenopausal as determined by menstrual history (no change in menstrual pattern
in prior 6 months) and an FSH level less than 15 mIU/ml obtained on the third day of the
menstrual cycle.

Have undergone genetic counseling and risk assessment.

Must be a known mutation carrier or be a first- or second-degree relative of an individual
with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known
BRCA mutation.

Agree to release of genetic test result for stratification purposes, whether or not she
has chosen to receive individual test results for clinical decision-making.

Be willing to use non-hormonal methods of contraception until completion of the 3 month
follow-up studies.

Have an ECOG performance status of 0-1.

Be able to provide informed consent.

Exclusion Criteria - Menstrual Cycle Study:

Any of the following will result in exclusion from the Menstrual Cycle Pilot Study:

A history of menstrual cycle irregularities over the previous 6 months, including history
of cycles less than 26 days or more than 35 days.

Steroid therapy, use of selective estrogen receptor modulators (SERMs) or hormonal agents
(including tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives,
depoprovera, progestin IUD, oral progestins, norplant, or drugs to induce ovulation)
within 6 months prior to study entry and must agree not to use these compounds until
completion of the three-month follow-up study.

Pregnancy or lactation within 12 months of enrollment.

History of infertility with a suspected ovarian etiology or persistent ovarian cyst.

Abnormal CA-125 level.

History of invasive cancer except for non-melanoma skin cancer or cervical carcinoma in

Creatinine greater than 2.

Previous bilateral mastectomy, bilateral radiation therapy to the breast, or oophorectomy.

History of DCIS or LCIS .

Weight over 136 kilograms.

Allergy to gadolinium.

Allergy to lidocaine or Marcaine (bupivacaine) (excluded from breast duct lavage only).

Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would
preclude informed consent or ability to participate in clinical research.

Inclusion Criteria - Training Cohort:

To participate in the Training Cohort a volunteer must:

- Be female and at least 18 years and less than 51 years of age.

- Have at least one breast considered eligible for study.

- Provide evidence (either films or radiologist's report) of a mammogram done within
the 12 months prior to enrollment showing low or no suspicion of carcinoma in at
least one breast. (Mammograms will not be provided to participants as part of the
training cohort.)

- Have a physical examination of the breast to be studied consistent with low or no
suspicion of carcinoma at the time of enrollment.

- Provide the name of a primary care physician to whom the results of breast duct
lavage cytologies can be sent.

- Have signed the informed consent for breast duct lavage.

Exclusion Criteria - Training Cohort:

Any of the following will exclude a potential participant from the Training Cohort:

- Pregnancy or lactation within the past 12 prior to enrollment.

- Subareolar or other surgery of the breast to be studied (papilloma resection, biopsy
or fine needle aspirations which might disrupt the ductal systems within 2 cm of the
nipple. (Biopsies of fine needle aspirations of the breast greater than or equal to
2 cm from the nipple are acceptable.)

- A breast implant or prior silicone injections in the breast to be studied.

- Radiation therapy to a breast to be studied.

- Active infections or inflammation in a breast to be studied.

- Chemotherapy or a selective estrogen receptor modifier (e.g., tamoxifen or raloxifen)
taken within 12 months prior to enrollment.

- A known allergy to lidocaine, prilocaine or Marcaine (bupivacaine).

Type of Study:


Study Design:


Principal Investigator

Jennifer T Loud, C.R.N.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • Healthy
  • Ovarian Cancer
  • BRCA-1/2
  • Cancer Detection
  • MRI
  • PET
  • Screening
  • Healthy Volunteers
  • Breast
  • Imaging
  • Menstrual Cycle
  • Healthy Volunteer
  • Breast Neoplasms
  • Ovarian Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892