Case History 1
Sue (not her real name), a 69 year old female, visited Dr. Steven Drosman’s office on 6/14/06 for her annual well woman exam. She underwent the HALO® Breast Pap Test,
producing Nipple Aspirate Fluid from her left breast. On 6/19/06 her HALO sample was viewed by a pathologist, with findings of atypical cells present. Sue’s prior screening
mammograms were all normal. She was then referred to a surgeon who requested that she have a diagnostic mammogram and ultrasound of her left breast before seeing
him. She had the diagnostic mammogram and ultrasound on 8/07/06 which showed “no solid mass or dilated duct.” On 8/21/06, he noted that she did not have a family history,
she had a low risk of breast cancer on the Gail model, and no suggestion of cancer whatsoever. Then, on 9/20/07, as part of Sue’s follow-up, she had a digital mammogram.
There were noted calcifications in the 12 o’clock position of the left breast and a follow up digital mammogram with spot magnification was ordered. On 10/20/07, Sue’s follow up
mammogram confirmed microcalcifications in the 12 o’clock position of the left breast and she was scheduled for a stereotactic core biopsy of her left breast on 11/2/07. The
results of the biopsy were Ductal Carcinoma in Situ (DCIS). The patient was then referred to a surgical oncologist who recommended surgery and radiation therapy.
Comments by Dr. Steven Drosman
Sue is like so many of my patients who have no identifiable risk factors for breast cancer.
In the past, we’ve had to just wait for lesions to develop that were large enough to be
seen on a screening mammogram or to be felt on a breast exam. Cellular atypia is a
significant risk factor for developing breast cancer. HALO® helps us stratify patients
according to risk level so we can get the right women to the breast specialists for follow
up, with the goal of catching abnormalities earlier in the disease process.
Comments by Sue
I’ll be honest, the abnormal HALO results initially caused me some anxiety, but it was so worth it! It made me much more conscientious about breast exams and getting my
mammograms on time, plus I had the benefit of consulting with a breast specialist.
Thanks to HALO my cancer was caught early before it had a chance to spread beyond the milk duct, and my prognosis is great.
Case History 2
Atypia Finding Prompts Follow up That Identifies Lesion
When Judy visited her ObGyn for her annual well woman exam in October 2008,
her recent breast health history was problematic but not overly concerning. She
was 46 with no family history or other risk factors for breast cancer. A routine
mammogram had revealed an abnormality—a calcification in her left breast—
which a follow-up spot compression mammogram had confirmed. The
microcalcification was in the same area as a cyst that had been detected by
breast ultrasound the year before, so the radiologist recommended a stereotactic
biopsy of the left breast.
NAF Result Convinces Patient to Undergo Biopsy
Before deciding to undergo the biopsy, Judy scheduled an appointment with
ObGyn Jigisha Upadhyaya, M.D. for a well woman exam. During the exam,
Dr. Upadhyaya suggested she take the HALO® Breast Pap Test and Judy agreed.
The pathologist analyzing the test results found atypia in Judy’s left breast.
Based on those results, Dr. Upadhyaya strongly recommended that Judy
undergo the biopsy.
“HALO increased my suspicion that something was wrong,” Dr. Upadhyaya says.
“It helped me recommend more forcefully that Judy go after the biopsy.
Ordinarily, she might have ignored the radiologist’s recommendation because
she had no symptoms.”
According to Dr. Upadhyaya, the HALO results also motivated the radiologist
and the surgeon performing the biopsy to be more aggressive in their pursuit of
an answer. The initial biopsy was negative. Without HALO, they might have
stopped looking at that point and recommended another mammogram or
ultrasound in six months. Instead, a second biopsy was performed, which found
atypical papillary hyperplasia, a pre-cancer that the pathologist believed might be
DCIS (ductal carcinoma in situ).
HALO Provides Critically Important Factor
The lesion was removed by lumpectomy in December 2008. Judy also received
three weeks of radiation therapy as a precaution. She agrees with Dr. Upadhyaya
that the HALO results were the critical factor in motivating her to go forward with
the biopsies that ultimately found the lesion. “If I had not had the HALO test, I
might not have thought the situation was serious enough to do anything about
it,” she says. “I tell people this machine saved my life.”
Case History 3
HALO Atypia Prompts Woman to Enter Program for High-Risk Patients
Tracy, 44, had more than the usual reasons to be conscientious about her breast
health. Her mother had pre-malignant breast lesions and her mother’s identical twin
sister had breast cancer.
Tracy’s two mammograms prior to her June 2008 well woman exam had both been
negative. When Tracy visited her Ob/Gyn for the exam, her physician recommended
the HALO® Breast Pap Test to her, telling Tracy that she took it annually to help
monitor her own breast health. Tracy decided to take it, as well.
Atypia Leads Ob/Gyn to Refer to Surgeon
Tracy’s right breast secreted nipple aspirate fluid (NAF) during the test, and the
pathology report showed mild atypia. That atypia identified Tracy as a patient at high
risk for breast cancer. On this basis, her Ob/Gyn referred Tracy to Alice Police, M.D.,
a breast surgeon whose practice supports NAF testing with HALO and
offers a breast cancer prevention program for high-risk patients.
Dr. Police found that Tracy had yet another risk factor: extremely dense breasts, which
can also obscure cancer on a mammogram. She ordered three imaging exams for
Tracy: a mammogram, an ultrasound, and an MRI. Correlating the results of these
exams, Dr. Police concluded that Tracy had abnormalities in both breasts and that the
two abnormal areas in the right breast were suspicious for cancer. She recommended
surgery to remove the right breast abnormalities.
The surgical pathology report showed that Tracy had three papillomas in her right
breast that were benign. Still, Dr. Police felt that Tracy’s risk profile including the atypia
justified increased monitoring and further testing. She referred Tracy to a genetic
counseling program. She also recommended that Tracy be examined and have breast
images taken every 6 months, rotating between a mammogram and an MRI. Tracy
quickly agreed to follow the recommendations.
Praise from Patient and Physician
Tracy is grateful for the role HALO played in getting her into a prevention/monitoring
program. “I feel fortunate to have been exposed to the HALO test and think it is a
proactive and incredibly valuable tool,” she says.
Dr. Police believes HALO may have helped save Tracy’s life. “HALO was critical in
identifying Tracy as a high risk patient,” she says. “We’re now following her in a highrisk
follow-up program and are likely to catch any cancer very early. It is unlikely she
will ever die of invasive breast cancer because she will be followed so closely.”
Case History 4
HALO Atypia Causes Enhanced Surveillance, Leading to Early Detection
64-year-old post-menopausal Anna had a HALO Breast Pap Test in March of
2008 as part of her well-woman exam. She produced nipple aspirate fluid
from her right breast with cytology findings of mildly atypical ductal cells.
She had been having regular mammograms, all of which were normal, but
her sister had a history of breast cancer. The patient was then referred to the
breast surgeon who ordered a mammogram and breast MRI, which were
In October of 2008, a follow-up bilateral screening mammogram and right
breast ultrasound were both negative.
As part of Anna’s annual gyn exam in March of 2009, she again underwent
the HALO test, but this time she produced a large volume of bloody fluid
from her right breast. Again the cytology showed atypical ductal cells. Followup
bilateral mammogram and right breast ultrasound were both negative.
However, based on the abnormal HALO findings another MRI was done.
Abnormalities Visible on MRI One Year Later
This time two areas in the right breast were suggestive of malignancy.
Subsequent ultrasound-guided biopsies of the two lesions confirmed ductal
carcinoma in situ (DCIS). Anna underwent a lumpectomy and sentinal node
biopsy with pathology showing well-differentiated infiltrating ductal
carcinoma measuring 0.5 cm in diameter. She has subsequently undergone
radiation therapy and is about to begin systemic hormonal treatment.
Risk Assessment May Save Lives
“Her chance of survival is very high because of the early diagnosis. Had the
cancer been discovered at a later time it is likely that her prognosis would be
less favorable. I credit HALO for my patient’s early breast cancer detection
and subsequent treatment” says Anna’s gynecologist, Dr. Robin Wedberg.