ELACESTRANT TAB
Clinical Criteria Summary
Document 459
Indication & Patient Population
- • Treatment of ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer (MBC)
- • Indicated after progression on/after >1L endocrine therapy in men or postmenopausal women
- • Prior therapy must include 1L with a CDK4/6 inhibitor + AI or fulvestrant, OR progression on/within 12 months of adjuvant endocrine therapy
Clinical Monitoring & Management
- • Evaluate hepatic function at baseline and throughout the course of treatment
- • Evaluate lipid profile at baseline and throughout the course of treatment
- • Assess for potential drug-drug interactions at baseline and throughout treatment
- • Take daily dose with food to minimize GI distress
Contraindications & Warnings/Precautions
- • Contraindications: None
- • Boxed warnings: None
- • Warnings/Precautions: Dyslipidemia, Embryo-fetal toxicity
- • Avoid use in severe hepatic impairment (Child-Pugh C)
- • Dose-reduce in moderate hepatic impairment
Drug Interactions & Administration
- • Avoid concomitant use with moderate-strong CYP3A4 inducers or inhibitors
- • Use caution with P-gp substrates and BCRP substrates due to increased concentration and adverse effects
- • Dosage form: Oral tablets (86 mg and 345 mg)
Document 458
Exclusion Criteria
- Hypersensitivity to elacestrant or any of its components
- Severe hepatic impairment (Child-Pugh C)
Inclusion Criteria
- Men or postmenopausal women with advanced or metastatic breast cancer
- Hormone receptor (HR)-positive, HER2-negative breast cancer
- ESR1-mutation positive as detected by an approved test
- Progressive disease on or after an endocrine-based regimen that included a CDK4/6 inhibitor [including adjuvant regimens if progress within 12 months]
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1
- Goals of care and role of Palliative Care consult have been discussed and documented
Additional Inclusion Criteria (Select if applicable)
- For patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 week after treatment.