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 unless this patient has either received capivasertib plus fulvestrant via the company early access programme and all other conditions on this form are complied with or this patient is switching from treatment with alpelisib plus fulvestrant due to toxicity (see criterion 10 below).
10. The patient has not previously received any treatment with a PIK3CA-targeted drug (such as alpelisib) unless this patient has received previous treatment with alpelisib plus fulvestrant but such treatment with alpelisib plus fulvestrant has had to be stopped within 6 months of its start solely as a consequence of excessive toxicity and in the clear absence of disease progression and if all other treatment criteria on this form apply. Please record which scenario applies to this patient:

• the patient has not previously received any treatment with a PIK3CA-targeted drug or
• the patient has received previous treatment with alpelisib plus fulvestrant but such treatment with alpelisib plus fulvestrant has had to be stopped within 6 months of its start solely as a consequence of excessive toxicity and in the clear absence of disease progression and all other treatment criteria on this form apply

11. The patient has an ECOG performance status of 0 or 1.
12. Capivasertib will only be given in combination with fulvestrant. Note: capivasertib is not commissioned in combination with elacestrant.
13. Treatment with capivasertib plus fulvestrant will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner.
14. 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.
15. 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.
16. 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.
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. Capivasertib and fulvestrant will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).

CDF funded From: 11 April 2025

Additional information

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

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• CAP1_prior_to_cdf_1.361