Recurrent Metastatic ER+ Breast Cancer: Clinical Trials

Gretchen G. Kimmick, MD, MS:To summarize the case and my thoughts regarding what’s going on with her [the patient’s] case, I think that at this point in history, we’re sort of lacking clinical trials for adjuvant treatment. They’re so expensive and it’s hard to afford them. With tumors that are 5 cm, because she has a high-grade cancer and an Oncotype DX score that is in the high-risk range, I may have gone back and given her neoadjuvant treatment if I knew about her status before her surgery. This would allow for a lesser surgery.

We’re doing more and more clinical trials with basic science so that we have markers that determine what tumors will respond to what treatments. That’s really exciting. When I first started my career, drugs like the CDK [cyclin-dependent kinase]4/6 inhibitors, and even fulvestrant and eribulin were not available. Clinical trials have been done, these drugs have been discovered, more treatments are available, and patients are living a lot longer because they are responding longer to treatments. We offer clinical trials to patients to help them, and to keep their cancer under control. We also offer them so that we have things to offer to our kids, in the future, if they get cancer; or, for us, so that we continue having drugs coming through the pipeline. When patients are diagnosed with metastatic disease, it’s really hard to sit down with them and say, “Well, you’re going to be getting treatment until we can’t control the cancer with the treatment.”

I look forward to a day when clinical trials begin to show that the treatment’s working well, so that I don’t have to tell a patient that a treatment won’t work anymore. Maybe the treatment will make the cancer go away. So, that’s what we’re looking forward to with drug development and clinical trials—getting rid of the cancer, even when it has returned.

Transcript edited for clarity.

A 52-Year-Old Woman with MetastaticER+ Breast Cancer

March 2015

• A 52-year-old postmenopausal woman was referred for multidisciplinary assessment after being diagnosed with breast cancer, found incidentally on routine screening mammogram
  • Breast MRI revealed a 55-mm lesion in her left breast
  • FH includes a great aunt on her mother’s side who died of breast cancer at age 50
  • gBRCA1/2negative
• She underwent lumpectomy with axillary staging
• Biopsy findings:
  • Histology: invasive ductal carcinoma, grade 3
  • Hormone receptor status: ER+/ PR (-)
  • HER2,IHC 1+
  • OncotypeDx RS-high (27)
• Staging, T3BN0M0
• ECOG 1
• She completed 4 cycles of dose-dense doxorubicin/cyclophosphamide followed by 4 cycles of paclitaxel; she was then started on adjuvant letrozole

April 2017

• On routine follow-up, chest CT with contrast showed 4 small nodules in the left lung; biopsy confirmed metastatic breast cancer
  • Letrozole was changed to fulvestrant; imaging at 3 months showed progressive disease
  • She was subsequently started on treatment with capecitabine; imaging at 3 and 6 months showed a partial response
  • She was scanned for pulmonary embolism

April 2018

• On routine follow-up:
  • The patient complained of fatigue and new onset chest pain with deep breathing
  • FDG PET/CT showed 2 new liver lesions and progression in the lung lesions
  • ECOG 1
  • The patient was started on eribulin IV, with a dosing schedule of days 1 and 8, every 21 days