Clinician FAQ

What is the HALO Breast Pap Test and why do you recommend it?

This year, 40,000 women will die from breast cancer and approximately 180,000 women will be diagnosed with breast cancer. The HALO Breast Pap Test is a simple, 5-minute, non-invasive breast cancer risk assessment test that detects cellular changes within the breast ducts early, before larger, potentially cancerous lesions might develop. 

 

Who gets tested? How often?

HALO is a risk assessment test recommended annually for asymptomatic women ages 25 to 55.

 

What does HALO look for?

The HALO Breast Pap Test is a collection device that uses a combination of warmth, massage and suction to elicit Nipple Aspirate Fluid (NAF) from the milk ducts. If NAF is produced, the sample is sent to the lab and reviewed for atypical cell development, similar to a Cervical Pap Test. 

 

What percentage of women tested have atypia?

Approximately 1% of asymptomatic women will have atypia. Atypia confers a 4x to 5x relative risk of developing breast cancer.

 

If a woman has atypia, does it mean that she has cancer or that she will get cancer?

No, it simply means she is at greater risk. Atypia confers a 4x to 5x relative risk of developing breast cancer. Although most women with atypia will not develop cancer, experts generally agree that all invasive cancer was, at one point, atypia. HALO helps identify these high-risk women, allowing for early intervention. Almost all treatment options are non-surgical and include lifestyle changes such as smoking cessation, weight loss, etc. Other options include increased surveillance using more sophisticated imaging like ultrasound, diagnostic mammogram or MRI. Chemoprevention may also be used as a treatment option. Any treatment options for high risk women with atypia should be considered in conjunction with all other risk factors.

 

Is HALO a diagnostic test?

No, HALO is not a diagnostic test. A diagnostic test confirms whether or not symptomatic (with symptoms) patients actually have a disease. HALO is a risk assessment test meaning that it helps physicians stratify an asymptomatic woman’s risk of developing breast cancer in the future.

 

What do I do if atypia is found?

Finding women at risk is critical as most women diagnosed with breast cancer have no identifiable risk factors, other than age. With a diagnosis of atypia, patients are commonly referred to a breast specialist. 
Breast Specialists perform a complete risk assessment, including family history. Atypia, combined with anything meaningful in this assessment will dictate next steps. All patients will likely receive lifestyle counseling and increased surveillance. In addition, depending on the assessment, it may be appropriate to increase the imaging power to include diagnostic mammograms, ultrasound, or MRI. Chemopreventive counseling may also be appropriate, as might be some minor surgical options. In short, there are many options for a woman identified as being at high-risk and the basic lifestyle counseling and increased surveillance are important starting points.

 

What is the difference between HALO and Ductal Lavage?

Ductal lavage is an invasive procedure indicated only for high-risk women. In contrast, the HALO Breast Pap Test is a noninvasive screen to determine which asymptomatic women are at high risk for developing breast cancer. Studies show that atypia confers a significant increase in risk, typically 4X to 5X compared to women who do not produce fluid or produce fluid with no atypia present.
Atypia is an indicator of risk, so it is valuable in elevating a woman from “asymptomatic” to “high risk.” Because of this knowledge, patient management will be changed. Patients who undergo ductal lavage are are already considered high risk. A finding of atypia does not change this nor does it affect patient management. Atypia is helpful to identify a high risk patient but has minimal value if the patient is already known to be high risk.

 

What can breast specialists do with the information?

Breast specialists have a variety of treatment options and protocols for managing women at high risk for breast cancer. First, they are likely to perform a complete risk assessment including lifestyle counseling, genetic counseling, family history, etc. This will help them decide whether enhanced imaging like ultrasound, diagnostic mammogram, MRI, or a follow up HALO test is warranted. Risk reduction strategies, such as lifestyle changes, will be discussed. There are also more aggressive options including chemopreventives, such as Tamoxifen or Raloxifene that may be appropriate.

 

Do all women produce NAF?

No. The percentage of NAF producers is demographically driven. In pre-menopausal Caucasian women, approximately 40-50% of asymptomatic women produce NAF. Literature shows that women who do not produce NAF are in the lowest risk category (which means normal risk) for developing breast cancer. The absence of NAF is considered a normal HALO result.

 

Aren't we giving women a false sense of security with a negative test?

HALO is a risk assessment test that allows for the identification of asymptomatic women who need closer surveillance. A negative test, like a negative cervical pap test, or a negative mammogram, does not guarantee that the patient does not have cancer. This is why HALO should be performed annually, along with clinical breast exams and routine mammograms.

 

Does HALO replace mammograms? 

No, HALO is a complement to mammograms. Mammograms look for lesions and are most effective as women age; clinical evidence shows they are not as effective in women under 50. In contrast, HALO is looking for abnormal cells, years before they might turn into a lesion, and the HALO test is effective in women as young as 25. Women start to decrease their production of NAF after 55, so as HALO becomes less important with age, mammograms become more effective. 

 

Won't this lead to unnecessary surgery? 

No, results from this test do not indicate surgery. HALO is screening test and surgery requires a diagnosis. Instead, HALO helps identify women who need closer surveillance, lifestyle counseling and perhaps some pharmaceutical options. 

 

Why do you call this the Pap test when this is very different from the Cervical Pap?

It is true that cervical and breast cancer are different and that our test is different from a cervical pap. The most important reason we call this the Breast Pap test is that it was first suggested by Dr. Papanicolaou. In 1958, he published an article outlining what should be done with NAF; giving him the credit for this test is appropriate. Further, although breast cancer is quite complex and the domain of the experts, the problem to date is not having a method for patients and their primary care doctors to identify asymptomatic women; using a familiar name will help them utilize this tool, as well as appreciate the need for annual testing, as they have learned to do with the cervical pap.

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