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

NCT00006425 | Completed

• 2 other identifiers: 01000801-C-0008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Women who carrying a BRCA1 or BRCA2 gene mutation or who are the first- or second-degree relative of an individual with a BRCA-associated cancer in a family documented to have a BRCA1 or BRCA2 mutation will be eligible for enrollment into this pilot study of breast cancer screening modalities. 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, breast MRI and PET scan will be scheduled initially during either the follicular or mid-luteal phase of the menstrual cycle. A unilateral cranio-caudal mammogram, and bilateral MRI and PET scan 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); (3) a semiquantitative measure of contrast enhancement (MRI); and (4) FDG uptake measured over time (PET scan). 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 annually. Consent for a PET study will be requested if an abnormality is detected on mammography or breast MRI requiring additional clinical or radiographic follow-up. 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.

Conditions

Breast Cancer

Keywords

Breast MRI; Ductal lavage; Nipple Aspirate Fluid; Transvaginal ultrasound

Outcome Measures

Primary Outcomes (1)

• Determine the effect of menstrual cycle phase on five breast imaging outcome measures.

  These are: 2 measures of mammographic density (qualitative and semiquantitative), a semiquantitative measure of fibroglandular volume and of dynamic contrast enhancement (MRI), and FDG uptake over time (PET scan). We will determine if these measures vary between the carriers \& non carriers of BRCA1/2 mutations.Due to the difficulty in tracking and timing menstrual cycles in women who resided great distances from the NIH, we abandoned further recruitment after the pilot study of ductal lavage.

  Duration of study

Study Arms (1)

1

25 women undergoing ductal lavage

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As part of the Menstrual Cycle Pilot Study, we recruited 25 volunteers to assist in training study investigators in performing breast duct lavage. Cytologies obtained from volunteers were used to develop expertise in interpretation and management of women undergoing ductal lavage.

You may qualify if:

• 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.

You may not qualify if:

• 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 situ.
• 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.
• To participate in the Training Cohort a volunteer must:
• Be female and at least 18 years and less than 51 years of age.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer T Loud, C.R.N.P.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2000
• First Posted: November 1, 2000
• Study Start: December 19, 2000
• Primary Completion: December 31, 2005
• Study Completion: October 3, 2008
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

US (1)