Palbociclib in combination with fulvestrant [PAL2]

For hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer where the following criteria are met:

  1. This application for palbociclib in combination with fulvestrant is being made by and the first cycle of palbociclib 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 oestrogen receptor positive and HER-2 negative breast cancer.
  3. The patient has metastatic breast cancer or locally advanced breast cancer which is not amenable to curative treatment.
  4. The patient is male or is female and if female is either post-menopausal or if pre- or peri-menopausal has undergone ovarian ablation or suppression with LHRH agonist treatment.
  5. The patient has an ECOG performance status of 0 or 1 or 2.
  6. The patient has received previous endocrine therapy according to one of the three populations as set out below as these are the groups on which the NICE Technology Appraisal for palbociclib plus fulvestrant focused. Please record which population the patient falls into:
  • has progressive disease whilst still receiving adjuvant or neoadjuvant endocrine therapy for early breast cancer with no subsequent endocrine therapy received following disease progression or
  • has progressive disease within 12 or less months of completing adjuvant endocrine therapy for early breast cancer with no subsequent endocrine therapy received following disease progression or
  • has progressive disease on 1st line endocrine therapy for advanced/metastatic breast cancer with no subsequent endocrine therapy received following disease progression.
  1. The patient has had no prior treatment with a CDK 4/6 inhibitor unless either abemaciclib (in combination with fulvestrant) or ribociclib (in combination with fulvestrant) has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression or a CDK 4/6 inhibitor has been previously received as adjuvant therapy and treatment was completed without disease progression at least 12 months prior to the first diagnosis of recurrent or metastatic disease. Please mark below which one of these 4 scenarios applies to this patient:
  • no prior treatment with a CDK 4/6 inhibitor or
  • previous treatment with the CDK4/6 inhibitor abemaciclib in combination with fulvestrant but treatment has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease or
  • previous treatment with the CDK4/6 inhibitor ribociclib in combination with fulvestrant but treatment has had to be stopped within 6 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease or
  • previously received a CDK4/6 inhibitor with endocrine therapy in the adjuvant setting for high risk early breast cancer either via NHS England commissioned care or via a clinical trial and treatment with the CDK 4/6 inhibitor was completed without disease progression at least 12 months prior to the first diagnosis of recurrent or metastatic disease
  1. The patient has had no prior treatment with fulvestrant.
  2. The patient has had no prior treatment with everolimus.
  3. Palbociclib will only be given in combination with a fulvestrant.
  4. Treatment will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner
  5. 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.
  6. Palbociclib and fulvestrant will be otherwise used as set out in their Summaries of Product Characteristics (SmPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 24 January 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA836 (26 October 2022)

Current Form Version

Note

The data on this page was produced using version 1.343 of the CDF list, downloaded from an archive of NHS England’s website on 26 January 2025 at 22:41.

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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