Palbociclib (in combination with an aromatase inhibitor) [PAL1]

The treatment of previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer

  1. This application for palbociclib in combination with an aromatase inhibitor is made by and the first cycle of systemic anti-cancer therapy 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 had no prior treatment with a CDK 4/6 inhibitor unless either ribociclib or abemaciclib 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 abemaciclib has been previously received as adjuvant therapy and treatment with abemaciclib 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 1st line CDK4/6 inhibitor abemaciclib 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 1st line CDK4/6 inhibitor ribociclib 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 adjuvant abemaciclib for high risk early breast cancer and treatment with abemaciclib was completed without disease progression at least 12 months prior to the first diagnosis of recurrent or metastatic disease
  1. The patient has metastatic breast cancer or locally advanced breast cancer which is not amenable to curative treatment
  2. 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
  3. The patient has had no previous hormone therapy for locally advanced or metastatic disease i.e. is hormone therapy naïve for locally advanced/metastatic breast cancer. Note: previous hormone therapy with anastrazole or letrozole whether as adjuvant therapy or as neoadjuvant treatment is allowed as long as the patient has had a disease-free interval of 12 months or more since completing treatment with anastrazole or letrozole.
  4. Palbociclib will only be given in combination with an aromatase inhibitor
  5. The patient has an ECOG performance status of 0 or 1 or 2
  6. Treatment will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner
  7. Treatment breaks of up to 6 weeks are allowed, but solely to allow toxicities to settle
  8. Palbociclib will be otherwise used as set out in its Summary of Product Characteristics (SPC)

[NHS funded]{.badge .rounded-pill .bg-success} From: 20 March 2018

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CDF Managed Access: NA

NICE Technology Appraisal: TA495 (20 December 2017)

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