Frequently Asked Questions About Ductal Lavage

Ductal Lavage - Frequently Asked Questions

1. What is ductal lavage?

Ductal lavage is a new way to collect milk duct cells, which are sent to a laboratory to determine whether they are normal or abnormal. If abnormal cells are found, they indicate increased breast cancer risk. Determining whether abnormal cells exist can help high-risk women and their physicians weigh the pros and cons of various risk reduction options.

Because ductal lavage can be performed in the same milk duct repeatedly, cell behavior can be followed over time. This kind of real-time information offers another method of ongoing surveillance for high-risk women.

2. What are atypical cells?

Atypical cells are cells with abnormal characteristics. Atypical cells are not necessarily pre-cancerous, but are known to indicate an increased risk of breast cancer.

3. Why is it important to find atypical cells?

Atypical cells have long been known as a risk factor for breast cancer. A number of published, peer-reviewed clinical studies have shown that atypical cells increase a woman’s risk by 4-5 times compared to woman without atypical cells. Among women with a family history of breast cancer, the presence of atypical cells has been shown to increase risk even further compared to women who does not have atypical cells and a family history.[1]

If ductal lavage identifies atypical cells in a high-risk woman, there are a number of ways to reduce her risk of developing breast cancer. Options include closer surveillance, the use of drug therapy and in cases of extremely high risk, preventative mastectomy.

In a recent study conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), drug therapy reduced the risk of breast cancer by 50% in the group of high-risk women studied. [2]

Deciding whether the potential benefits of drug therapy outweigh the potential downsides can be a difficult decision for high-risk women and their physicians. Determining whether atypical cells exist can be factored into the decision-making process along with information from mammograms, breast self-exams and clinical exams.

4. Is ductal lavage a breast cancer detection tool?

Ductal lavage is not currently a tool for breast cancer detection. It is used as a means of collecting cells in the breast to help assess breast cancer risk. While ductal lavage has detected a few early-stage cancers, it is too early to tell whether ductal lavage will be useful as a cancer detection method. Clinical research is needed to determine whether or not ductal lavage will be useful for this purpose.

5. Is ductal lavage a test for screening all women for breast cancer?

Ductal lavage is not a screening method for all women. Only women already at high-risk for developing breast cancer should be considered for ductal lavage.

6. I’ve heard ductal lavage described as a Pap Smear for the breast. Are these techniques similar?

Ductal lavage is used to collect cells from inside the breast. In this way, the concept of ductal lavage is similar to a Pap Smear, which is used to collect cells from inside the cervix. However, a Pap Smear is used to screen all women for cervical cancer. Ductal lavage is used only with women already at high-risk for breast cancer.

7. Is ductal lavage a replacement for mammography and physical examination?

Ductal lavage should be used only as an adjunct to standard breast cancer detection methods including mammography and physical examination. Ductal lavage provides additional information to high-risk women without changing or detracting from current practices.

8. If normal cells are found initially, can you re-check them in the future?

The same milk ducts can be re-tested at regular intervals so that the cells in those ducts can be followed over time. In this way, ductal lavage provides high-risk women with another means of ongoing surveillance.

9. What clinical data is available on ductal lavage?

A multi-center clinical study was conducted with 507 high-risk women at 19 prestigious breast centers in the United States and Europe. All study participants had received negative mammograms and physical exams within the 12 months prior to their enrollment in the trial. Abnormal cells were identified in 24% of the participants who received ductal lavage.

10. If atypical cells are found, how is this information different from other breast cancer risk assessment methods?

Most methods of assessing risk apply well to predicting which women out of a large population are most likely to develop breast cancer. They may work less reliably for estimating an individual woman’s risk. In contrast, ductal lavage provides cell-based risk information, which is unique and specific to each woman.

11. How do most women respond to ductal lavage?

Most women do not find ductal lavage painful since an anesthetic cream numbs the outside of the breast beforehand and a liquid anesthetic is flushed into the duct to numb the inside.

Participants in a multi-center clinical study were asked to rate their comfort level during ductal lavage on a 10-point scale. A rating of 1 corresponded to “painless” and a rating of 10 corresponded to “painful.” The median response was 2.4.

12. Are the ductal lavage devices FDA-approved?

13. Where is ductal lavage available?

Physicians who have been trained to perform ductal lavage, and are accepting referral patients, are listed on the Internet at www.ductallavage.com. The web site is updated frequently to include newly trained physicians. This information also is available through a toll-free line for high-risk women (1-866-4-INDUCT).

14. Who is Pro·Duct Health?

Pro·Duct Health is a medical device company based in Menlo Park, CA. The company manufactures the devices used in ductal lavage, and is dedicated to eradicating breast cancer by enabling the earliest possible detection and treatment of breast pre-cancer and cancer. General information about the company can be found at www.ductallavage.com.

[1] Dupont W, Page D. Risk Factors for Breast Cancer in Women with Proliferative Breast Disease. N Engl J Med. 1985; 312: 146-151.
Dupont W, et al. Breast Cancer Risk Associated with Proliferative Breast Disease and Atypical Hyperplasia. Cancer. 1993; 71: 1258-1265.
Fabian et al., “Short-Term Breast xz Cancer Prediction by Random Periareolar Fine-Needle Aspiration Cytology and the Gail Risk Model,” J Natl Cancer Inst 92:1217-1227 (2000).
Wrensch, et al., “Breast Cancer Incidence in Women with Abnormal Cytology in Nipple Aspirates of Breast Fluid,” Am. J. Epidemiology 135:130-141 (1992).

[2] Fisher et al., “Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study,” J Natl Cancer Inst 90:1371-1388 (1998).