Medicines advice

In combination with fulvestrant for the treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-; defined as IHC 0 or 1+, or IHC 2+/ISH) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen.

For the treatment of postmenopausal women, and men, with oestrogen receptor-positive (ER+), human epidermal factor receptor 2-negative (HER2-), locally advanced or metastatic (m) breast cancer (BC) with an activating oestrogen receptor 1 (ESR1) mutation (mut) who have disease progression following at least one line of endocrine therapy (ET) including a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i).

As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

Monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment

In combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.s

In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

Monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2−negative locally advanced or metastatic breast cancer (mBC). Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with HR+ breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

As monotherapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.

In combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery) for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence.

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens.

In combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence. In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy.

In combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease

Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.

In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens

As monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments.

Early breast cancer (EBC)
In combination with chemotherapy in:
• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence

Metastatic breast cancer (MBC)
In combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.

In combination with palbociclib and fulvestrant for the treatment of adult patients with PIK3CA‑mutated, oestrogen receptor (ER)‑positive, HER2‑negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.