Elacestrant monotherapy [ELAC1]

For the treatment of oestrogen receptor- positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with at least 12 calendar months of therapy with a CDK4/6 inhibitor-based combination where the following criteria have been met:

1. This application for elacestrant is being made by and the first cycle of elacestrant will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has histologically or cytologically documented diagnosis of oestrogen receptor positive and HER-2 negative breast cancer.
3. The patient’s breast cancer has an activating ESR1 mutation identified using a validated test. Note: elacestrant’s SPC states that the presence of activating ESR1 mutation should be based on use of a plasma specimen. Please document below whether the PIK3CA mutation status is known or not and if known whether the patient has a dual mutation positive cancer or one bearing just an ESR1 mutation

• the PIK3CA mutation test result is not currently known or
• the patient is known to be solely positive for an ESR1 mutation (ie the PIK3CA test is negative) or
• the patient has dual mutation positive disease (ie both ESR1 and PIK3CA tests are positive)

4. The patient has metastatic or locally advanced breast cancer which is not amenable to curative treatment.
5. The patient’s menopausal status has been considered and if appropriate the patient has undergone ovarian ablation or suppression with LHRH agonist treatment.
6. The patient has progressive disease after previous endocrine-based therapy.
7. The patient has been previously treated with at least 1 prior line of endocrine therapy in combination with a CDK4/6 inhibitor.
8. The patient has been previously treated with at least 12 calendar months of treatment with a CDK4/6 inhibitor. Please record in which places in the treatment pathway the patient had CDK4/6 inhibitor therapy:

• solely for early breast cancer or
• solely for locally advanced/metastatic breast cancer or
• in both early and advanced breast cancer settings Note: the company submitted a case to NICE for consideration of elacestrant’s clinical and cost effectiveness only in patients previously treated with at least 12 calendar months of therapy with a CDK4/6 inhibitor. This population is narrower than that in the marketing authorisation. Note: NHS England does not commission the use of elacestrant in patients who have had less than 12 calendar months of prior therapy with a CDK4/6 inhibitor-based combination.

9. The patient has been previously treated with the combination of alpelisib plus fulvestrant or not:

• No, the patient has not received prior alpelisib plus fulvestrant or
• Yes, the patient has been previously treated with alpelisib plus fulvestrant

10. The patient has had no more than 1 prior line of cytotoxic chemotherapy for advanced/metastatic disease.
11. The patient is an appropriate candidate for the use of further endocrine therapy.
12. The patient has not previously received treatment with elacestrant unless this was via a company early access scheme and all treatment criteria on this form are complied with.
13. The patient has an ECOG performance status of 0 or 1.
14. Elacestrant will only be given as monotherapy.
15. Treatment with elacestrant will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner.
16. The prescribing clinician is aware of both the potential drug interactions between elacestrant and CYP3A4 inhibitors/inducers/other enzyme systems and any consequent elacestrant dose adjustments that are required, as outlined in sections 4.2, 4.4 and 4.5 of elacestrant’s Summary of Product Characteristics. Note: patients should be also be counselled that there is a known drug interaction between elacestrant and ingestion of grapefruit juice.
17. When a treatment break of up to 6 weeks beyond the expected 4-weekly cycle length is needed, I as the prescribing clinician will complete a treatment break approval form to restart treatment.
18. Elacestrant will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

CDF funded From: 19 December 2024

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CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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