Client (DOB 08/02/1974) was diagnosed in May 2024 with left breast invasive ductal carcinoma (ER+, PR−, HER2−, Grade 2, Ki-67 40%), ultimately staged at pT2pN1a (Stage IIB) after lumpectomy in July 2024. Despite a very high-risk Oncotype DX Recurrence Score of 63, a positive Signatera (liquid biopsy), and explicit oncology recommendations for dose-dense chemotherapy, radiation, and endocrine therapy, the patient is a Jehovah's Witness, and she refused all adjuvant treatment. By January 2025, she had developed biopsy-proven locoregional recurrence and distant metastatic bone disease (Stage IV). The records reveal several potential standard-of-care deviations spanning pre-diagnosis hormone therapy prescribing, diagnostic surveillance, adjuvant therapy administration, and documentation.
She believes her surgeons are to blame because they did not order an MRI before or after the breast CA surgery to ensure it was all removed. It looks like there may be some deviations in surgical care, but not sure of the impact. It looks like the biggest issue may surround the failure to offer an Axillary Lymph Node dissection after the client refused all adjuvant therapy. There is also a deviation in the margins. 0.2 cm vs. > 1 cm margin which was never corrected in the records.
Pre-Diagnosis Use of Testosterone Pellets without adequate breast cancer screening may be another SOC deviation.
Files:
Q: What’s the patient offered a mastectomy and axillary lymph node dissection based on frozen section of the Sentinel node biopsy?
A: Mastectomy and ALND were discussed as elective options before the operation — not offered intraoperatively based on a frozen section.
Q: How many lymph nodes were removed at the time of the sentinel node dissection and how many were positive?
A: 1 sentinel lymph node was removed, and 1 was positive (1/1), representing a 0.9 cm macrometastasis with no extracapsular extension.
Q: Was there extranodal extension?
A: Extranodal extension was not identified
Q: Was the Onoctype completed before surgery?
A: The Oncotype (RS = 63) was completed on 09/11/2024, and the mastectomy was not recommended until 01/13/2025
Q: Frozen sections are not performed now and were stopped in 2017 because of the AMAROS trial. Was an axillary US completed before surgery?
A: A complete breast ultrasound was performed on 05/09/2024 but we are missing the report.
Q: Genetics? What was the density of her breasts on mammogram?
A: extremely dense breasts based on three independent MRI reports
Q: If the patient had INVASIVE cancer the margins are no "no-tumor on ink." 2mm applies mainly to DCIS, but not DCIS with Invasive cancer.
A: Her cancer was pure invasive ductal carcinoma with no DCIS component whatsoever. By that standard her margins were widely negative at greater than 1 cm in all directions
Do you believe there might have been medical error?
This patient refused standard of care therapy. Any time breast conserving surgery is performed. It should be accompanied by radiation. Otherwise the patient should’ve had a mastectomy and sentinel node biopsy. I do agree that in the absence of any adjuvant therapy the patient should’ve undergone a mastectomy and axillary lymph node dissection. Having those details and documentation may be critical to this case. However, there is no role for an MRI in the postoperative setting to assess risk of recurrence based on surgical margins, etc..
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
This patients poor outcome was a direct result of their decision-making, and not due to the care provided by the practitioner.
What makes you a good expert for this case?
I’m a board certified surgical oncologist at a major academic institution
How often do you encounter cases similar to this one in your practice?
I am bored, certified and maintenance of certification is up-to-date. This is bread-and-butter general surgery.
Do you believe there might have been medical error?
Based on the evidence provided an ALND was not indicated UNLESS the ultrasound (demonstrated additional suspicious LN). The metastatic lesion to the LN was small and contained, so the current recommendations would be for a SLNBx with radiation to the lumpectomy site AND the Axilla. The Amaros and z11 trial demonstrated the same rate of local control with an ALND vs radiation with LESS morbidity to the arm. IF she had a suspicious US then additional biopsies of the LN or ALND would have been recommended. The patient DECLINED adjuvant therapy for a VERY aggressive breast cancer, so it's not surprising that she developed distant disease. An MRI would NOT have changed the outcome. A mastectomy is indicated for multicentric disease OR a large tumor. It is LOCAL control. She had locally ADVANCED disease at presentation with a high oncotype (63) indicating the need for systemic treatment which she refused. She does not have a case.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
See answer my answer above. The patient had an aggressive cancer Oncoyope 63 with a positive node at presentation. She declined therapy.
What makes you a good expert for this case?
I am a Fellowship Trained Breast Surgical Oncologist and Board Certified General Surgeon. I have been in practice for 19 years and have had extensive experience with breast cancer. developing programs and knowledge with the NCCN guidelines plus molecular testing.
How often do you encounter cases similar to this one in your practice?
More now that people use Google as a "research" tool and social media platforms recommending alternative treatment. Plus the increasing number of misconceptions in the media.
Do you believe there might have been medical error?
Considering the short interval between presentation and the presence of metastatic disease, it is likely the cancer was metastatic at presentation. The chosen surgery, the intra-operative decisions and the recommendations following surgery were within the standard of care. Even if a mastectomy and full node dissection had been performed after the patient refused adjuvant therapy, the metastatic disease would have still presented. Also, if the patient had received the adjuvant therapy she may not have had a local-regional recurrence although it is still likely she would have had metastatic disease. Finally, all sugical, medical and radiation interventions are meant to reduce the chance of recurrence but ultimately it is the biology of the tumor that dictates outcome. She had a Luminal B cancer which are known to be aggressive and rapidly growing. This was confirmed by the high Oncotype which carries a poor prognosis. In summary, I think her outcome was the result of the aggressive tumor biology and not the surgical or medical interventions which met the standard of care.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The type of cancer (Luminal B), high oncotype and short interval between presentation of the cancer and the identification of metastatic disease indicate the metastases were already established at presentation. Even if the treatment had not met the standard of care (which it did), the outcome would have been the same except that perhaps the local-regional recurrence may have been avoided if she had accepted adjuvant chemo and radiation. This, of course was not her doctors recommendation.
What makes you a good expert for this case?
I am a fully trained surgical oncologist practicing exclussively breast surgery in a high volume practice. I have been in practice since 1988 so I have an extensive experience in this area. I evaluate aproximately 225 new breast cancer cases a year. I have had leadership positions in the development, management and oversight of breast centers. I have run the multidisciplinary breast tumor conference for approximately 30 years. I also have an extensive forensic experience. I've reviewed over 100 cases, written multiple reports, have been deposed many times and have given trial testimony on many occasions.
How often do you encounter cases similar to this one in your practice?
This type of case is extremely common in my practice. As mentioned above, I evaluate about 225 new breast cancer cases per year, of which about 70 % are hormone receptor positive, her2neu negative.
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