HRpos HER2neg EBC : Pre-test

1.

Which of the following may indicate high-risk disease and candidacy for adjuvant therapy with a CDK4/6 inhibitor for a patient with newly diagnosed HR+/HER2- EBC?

A. 1-3 positive axillary lymph nodes on SLNB
B. Detection of an ESR1 mutation
C. Higher ER expression level
D. Premenopausal status

2.

Patient Case 1: Woman With Grade 3 ILC and 2 Positive Nodes

A 58-yr-old woman who is postmenopausal presents with a 3.5-cm right breast mass with 1 suspicious node

Initial breast biopsy reveals ILC, grade 3, with the following biomarkers
- ER 80%, PgR 30%, HER2- by IHC

Fine-needle aspiration of a palpable right axillary lymph node reveals adenocarcinoma of the breast

BRCA testing: negative

Patient undergoes right breast lumpectomy with SLNB

Right lumpectomy specimen reveals a 4-cm ILC with 2/3 positive nodes (T2N1)

Oncotype Dx RS 26

She completed TC x 4 cycles, followed by adjuvant radiation

She returns to the clinic now to discuss continued adjuvant treatment

In addition to extended-duration adjuvant endocrine therapy, what additional systemic therapy would be an appropriate treatment for this patient?

A. None; endocrine therapy alone
B. Abemaciclib only
C. Ribociclib only
D. Abemaciclib or ribociclib
E. Abemaciclib, palbociclib, or ribociclib

3.

Patient Case 2: Woman on Adjuvant Abemaciclib With Diarrhea

55-yr-old postmenopausal woman with T2N1 high grade invasive HR+/HER2- breast cancer started adjuvant abemaciclib 2 months ago

She calls to report side effects including 6-8 episodes a day of diarrhea despite taking as-needed antidiarrheal medication that is difficult to predict

She says her weight is stable and that she is eating and drinking without problems

She also noted fatigue despite adequate sleep and is having trouble returning to work as a result

You ask her to hold abemaciclib until her symptoms are resolving

What additional counseling would you provide for this patient as the most appropriate next step in her treatment?

A. She should restart abemaciclib with no change to dose or schedule, increasing the use of antidiarrheal medication
B. She should restart abemaciclib with a dose reduction and continue antidiarrheals as needed
C. She should switch from abemaciclib to ribociclib due to the emergent toxicity
D. She should stop adjuvant CDK4/6 inhibitor and continue on endocrine monotherapy

4.

Patient Case 3: Metastatic Recurrence While Receiving Adjuvant ET

57-yr-old postmenopausal woman had history of high-risk node-positive ER+/HER2- early breast cancer in 2021; she underwent surgery, received adjuvant chemotherapy and adjuvant radiation therapy, and was started on letrozole

She also initiated adjuvant abemaciclib but did not tolerate due to poor appetite and diarrhea and stopped it in early 2022 after 6 months of treatment with 2 dose reductions

She presents in spring 2025 with gradual fatigue and weight loss; imaging is notable for findings consistent with MBC, with lesions in bone, mediastinal lymph nodes, and 2 liver lesions

Liver biopsy confirms MBC: ER 50%, PgR 30%, HER2 1+

ctDNA evaluation shows an activating ESR1 mutation and an activating PIK3CA mutation

Laboratory testing is normal; despite her symptoms, she continues to work full time and walks her dog daily

Which first-line systemic therapy would you recommend?

A. Capecitabine
B. Elacestrant
C. Fulvestrant and CDK4/6i
D. Fulvestrant and PI3KCA inhibitor
E. Fulvestrant + palbociclib + inavolisib

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Advancing the Care of Patients With High-Risk HR-Positive/HER2-Negative Early Breast Cancer

Manali Bhave, MD

Erin F. Cobain, MD

Neil M. Iyengar, MD

Pretest

Please answer the questions below.

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