Kimberly Blackwell, MD: Clinical Trial Data Supporting These Choices

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Are there any clinical trial data that would inform this choice?

Making decisions for this patient is difficult because if you go to the literature and try to find clinical trials that say "for a patient who has had a type 2 aromatase inhibitor and has had fulvestrant, what is your best option?" I wish we had data that could help us understand what the next step should be. Unfortunately those trials are difficult to design and the endpoints are quite complicated, so we don't have a lot of trials that drive my decision.


ER+/HER2-Breast Cancer: Case 2

Mary is a 62-year-old woman, who in mid-2014 complained of rib pain. Rib plain films revealed a lytic lesion of the left 5th rib. Bone scan revealed multiple areas of uptake in the lumbosacral spine and ribs.

PET-CT revealed lytic lesions in the lumbosacral spine and ribs, and a 3 cm right upper lobe lesion in the lung with a PET SUV value of 6, indicating malignancy

A mammogram and ultrasound of the left breast revealed a 2 cm speculated mass in the upper outer quadrant of the left breast

Core needle biopsy of this lesion revealed infiltrating ductal carcinoma, ER 80%, Her2 negative

She was placed on denosumab 120 mg SQ monthly, and anastrozole 1 mg orally daily. Her pain resolved within 1 month, and on follow-up CT at 4 months her bone lesions appeared sclerotic and her lung lesion had reduced to 2 cm. Her anastrozole and denosumab were continued

In mid-2015 she again complained of worsening low back pain and left hip pain. Repeat PET-CT demonstrated new lytic lesions in the left iliac crest as well as an enlargement of the lung lesion to 4 cm.

She was placed on fulvestrant 500 mg IM monthly and denosumab was continued. Within 2 months her pain improved, and a repeat CT of the chest in late 2015 demonstrated reduction of the lung lesion to 2 cm

In March 2016 she complained of new right scapular pain. A PET-CT revealed new lytic lesions of the left scapula and right ribs, and a new lung nodule in the left upper lobe 1 cm in diameter with an increase in the right upper lobe lesion to 3 cm

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