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NCCP 00619 · version 4a

Adjuvant abemaciclib + endocrine therapy

The usual abemaciclib starting dose is 150 mg twice daily; a lower dose or altered schedule may be prescribed. Abemaciclib is taken twice daily continuously for up to two years with endocrine therapy, unless recurrence or unacceptable toxicity requires an earlier change. A four-week dispensing block is not a rest cycle. Endocrine treatment normally continues beyond abemaciclib.

Purpose, setting and alternatives

For eligible high-risk node-positive early breast cancer, adding abemaciclib to endocrine therapy reduces the risk of recurrence after surgery. HR-positive/HER2-negative node-positive early breast cancer at high recurrence risk: four or more positive axillary nodes, or one to three with tumour at least 5 cm and/or grade 3. The NCCP timing, prior-treatment and other exclusions remain applicable; this is not a node-negative or metastatic regimen.

Individual aim, expected benefit, uncertainty and planned duration

Reasonable alternatives, including not proceeding with this regimen

Material risks and support

Diarrhoea, dehydration and nausea
Low blood counts and infection
Liver-test abnormalities
Blood clots
Rare serious lung inflammation
Hot flushes, joint or muscle symptoms
Vaginal dryness and sexual effects
Bone loss with AI / ovarian suppression
Clot and uterine risks with tamoxifen

Discuss the treatment aim, alternatives, benefit and uncertainty, important medicine-specific risks, reproductive precautions, symptom support and planned duration. Confirm the endocrine partner and any ovarian-suppression plan. The timeline does not authorise a restart or certify clinical review.

Individual risks, interactions, menopause and fertility / contraception discussion

Monitoring and understanding

FBC, renal, liver and bone profile; ECG as clinically indicated. Confirm node-positive high-risk eligibility, definitive surgery and timing: within 16 months of resection and up to 12 weeks of endocrine treatment after the last non-endocrine treatment before starting. Assess VTE history, bowel function, all medicines, endocrine partner, ovarian suppression if using an AI before menopause, and bone/reproductive health. FBC, renal, liver and bone profile every two weeks for the first two months, monthly for the next two months, then as clinically indicated. More frequent liver monitoring for grade 2 or worse liver abnormalities. ECG is driven by clinical need; no routine ribociclib Day-14 ECG schedule. Early and ongoing diarrhoea review, hydration/intake, infection, clots, breathlessness and adherence; prompt action between appointments. Creatinine can rise through inhibited tubular secretion without a true fall in filtration; assess the clinical context and alternative renal measures if needed.

Review the whole-treatment map togetherPatient priorities, questions, understanding and follow-up

Clinician review / date; no patient identifiers

Consent can be reconsidered. This draft does not establish capacity, consent or treatment authorisation.

Sources and review

The NCCP regimen supplies the treatment rules. Separate guidelines supply the longer-term monitoring recommendations, with their qualifications retained.

Source reconciled; independent clinical, pharmacy and patient/PPI review pending