Ribociclib in combination with an aromatase inhibitor [RIB3]

Ribociclib in combination with an aromatase inhibitor as adjuvant treatment for high risk hormone receptor-positive and HER2- negative early breast cancer where the following criteria have been met:

1. This application for ribociclib in combination with an aromatase inhibitor is being made by and the first cycle of ribociclib plus an aromatase inhibitor will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has early breast cancer.
3. The patient has histologically or cytologically documented hormone receptor-positive and HER-2 negative breast cancer.
4. The patient has high risk early breast cancer as defined by having either 4 or more positive axillary lymph nodes or 1-3 positive axillary lymph nodes and a primary tumour size of ≥5cm and/or histologically grade 3 disease. Please mark in the box below which category applies to this patient:

• ≥4 positive axillary lymph nodes or
• 1-3 positive axillary lymph nodes and a primary tumour size ≥5cm or
• 1-3 positive axillary lymph nodes and histological grade 3 disease or
• 1-3 positive axillary lymph nodes and a primary tumour size ≥5cm and histological grade 3 disease Note: NICE has made an optimised recommendation for only those patients who would otherwise be eligible for adjuvant abemaciclib. NHS England does not therefore commission use of adjuvant ribociclib in any other population of patients with early breast cancer.

5. The patient has completed definitive locoregional therapy (surgery with or without radiotherapy).
6. The patient has completed any adjuvant or neoadjuvant chemotherapy. Please mark in the box below the relevant treatment that the patient did or did not receive:

• the patient did not receive any adjuvant or neoadjuvant chemotherapy or
• the patient received adjuvant chemotherapy only or
• the patient received neoadjuvant chemotherapy

7. The patient has currently received no more than 12 months of adjuvant or neoadjuvant endocrine therapy.
8. If the patient is a pre- or peri-menopausal female then the patient has undergone ovarian ablation or suppression with LHRH agonist treatment or if the patient is male then the patient has undergone treatment with LHRH agonist treatment. Please mark in the box below which category applies to this patient:

• post-menopausal female on adjuvant aromatase inhibitor therapy or
• pre- or peri-menopausal female on adjuvant aromatase inhibitor therapy and LHRH agonist treatment/ovarian ablation or
• male on LHRH agonist treatment

9. The patient has an ECOG performance status of 0 or 1.
10. Ribociclib is being given only in combination with an aromatase inhibitor.
11. The patient has had no prior treatment with a CDK 4/6 inhibitor unless either the patient is transferring from a company early access scheme for adjuvant ribociclib AND meets the criteria on this form or the patient has suffered unacceptable toxicity on adjuvant abemaciclib plus endocrine therapy without any evidence of disease progression and is transferring to treatment with adjuvant ribociclib plus an aromatase inhibitor. If the latter, the treatment plan should be for a maximum CDK4/6 inhibitor treatment duration of 3 calendar years in all (time on abemaciclib plus that on ribociclib). Please mark in the box below which scenario applies to this patient:

• the patient has never received any prior therapy with any CDK4/6 inhibitor or
• the patient is transferring from a company early access scheme for adjuvant ribociclib AND meets all the criteria on this form or
• the patient has suffered unacceptable toxicity on abemaciclib plus endocrine therapy without any evidence of disease progression and is transferring to treatment with adjuvant ribociclib plus an aromatase inhibitor with a treatment plan for a maximum CDK4/6 inhibitor treatment duration of 3 calendar years in all

12. Treatment with ribociclib will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment or for a maximum of 3 calendar years, whichever is the sooner. For patients switching from abemaciclib, the maximum total CDK4/6 inhibitor treatment duration is for 3 calendar years (time on abemaciclib plus time on ribociclib).
13. The prescribing clinician is aware that the dose of ribociclib in this adjuvant indication for early breast cancer is not the same as that in its indications in advanced/metastatic breast cancer.
14. The prescribing clinician is aware of ribociclib’s interactions with CYP3A4 inhibitors and inducers as outlined in ribociclib’s Summary of Product Characteristics.
15. The prescribing clinician is aware of the necessary ribociclib dose adjustments for neutropenia, increased aminotransferases, interstitial lung disease and QT prolongation as outlined in ribociclib’s Summary of Product Characteristics.
16. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
17. Ribociclib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 24 April 2025

Additional information

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CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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Note

The data on this page was produced using version 1.360 of the CDF list, downloaded from an archive of NHS England’s website on 25 April 2025 at 14:00.

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.

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