Capivasertib in combination with fulvestrant [CAP1]

Capivasertib in combination with fulvestrant for hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with a CDK4/6 inhibitor and an aromatase inhibitor where the following criteria have been met:

1. This application for capivasertib in combination with fulvestrant is being made by and the first cycle of capivasertib plus fulvestrant 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 hormone receptor positive and HER-2 negative breast cancer.
3. The patient’s breast cancer has a PIK3CA or an AKT1 or a PTEN genomic alteration identified using a validated test. Please set out below which genomic alteration(s) has/have been found on testing:

• solely a PIK3CA alteration or
• solely a AKT1 alteration or
• solely a PTEN alteration or
• 2 or more of these 3 genomic alterations

4. The patient has metastatic or locally advanced breast cancer which is not amenable to curative treatment.
5. If the patient is female and pre- or peri-menopausal, the patient has undergone ovarian ablation or suppression with LHRH agonist treatment and if the patient is male, consideration has been given to administration of LHRH agonist therapy.
6. The patient has progressive disease after previous endocrine-based therapy.
7. The patient has been previously treated with an aromatase inhibitor.

• solely for early breast cancer or
• solely for locally advanced/metastatic breast cancer or
• in both early and advanced breast cancer settings

8. The patient has been previously treated 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 clinical and cost effectiveness only in patients previously treated with a CDK4/6 inhibitor and an aromatase inhibitor. This population is narrower than that in the marketing authorisation.

9. The patient has had no prior treatment with fulvestrant for any indication.
10. The patient has an ECOG performance status of 0 or 1.
11. Capivasertib will only be given in combination with fulvestrant. Note: capivasertib is not commissioned in combination with elacestrant.
12. Treatment with capivasertib plus fulvestrant will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever the sooner.
13. The prescribing clinician is aware of the potentially serious side-effects of capivasertib (particularly hyperglycaemia, cutaneous reactions, diarrhoea) and of the necessary capivasertib dose adjustments for these toxicities, as outlined in capivasertib’s Summary of Product Characteristics.
14. Before starting treatment the patient will undergo testing for fasting blood sugar and HbA1C and should this patient develop hyperglycaemia, a consultation with a diabetologist will be considered when selecting the anti-diabetic medication because of the risk of hypoglycaemia particularly on non-dosing days of capivasertib.
15. The prescribing clinician is aware of the various potential drug interactions between capivasertib and other drugs, as outlined in section 4.5 of capivasertib’s Summary of Product Characteristics.
16. 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.
17. Capivasertib and fulvestrant will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

CDF funded From: 11 April 2025

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