Olaparib in combination with hormone therapy [OLAP6]

As adjuvant treatment of high-risk HORMONE RECEPOR POSITIVE HER 2 NEGATIVE early breast cancer treated with neoadjuvant or adjuvant chemotherapy and definitive local therapy in patients with a deleterious or suspected deleterious germline BRCA mutation where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with olaparib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient has a proven histological diagnosis of hormone receptor positive and HER 2 negative breast cancer.
3. This patient has early breast cancer.
4. This patient HAS a documented germline deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s). Please enter below as to which deleterious or suspected deleterious BRCA mutation(s) the patient has:

• BRCA 1 mutation or
• BRCA 2 mutation or
• both BRCA1 and BRCA 2 mutations

5. The patient has recently completed either neoadjuvant chemotherapy or adjuvant chemotherapy. Please enter below as to whether the patient was treated with a neoadjuvant cytotoxic chemotherapy-containing regimen or an adjuvant cytotoxic chemotherapy-containing chemotherapy regimen:

• the patient was treated with a neoadjuvant cytotoxic chemotherapy-containing regimen or
• the patient was treated with an adjuvant cytotoxic chemotherapy-containing regimen

Note

Note: adjuvant olaparib without the use of prior neoadjuvant or adjuvant cytotoxic chemotherapy is not funded.

6. The patient was treated with at least 6 cycles of an anthracycline-containing regimen or at least 6 cycles of a taxane-containing regimen or at least a total of 6 cycles of anthracycline-containing and taxane-containing regimens. Please mark below which option applies to this patient:

• the patient received at least 6 cycles of an anthracycline-containing regimen or
• the patient received at least 6 cycles of a taxane-containing regimen or
• the patient received at least a total of 6 cycles of anthracycline-containing and taxane-containing regimens

7. Which definition of high-risk early breast cancer applies to this patient noting that this depends on whether the patient had neoadjuvant or adjuvant chemotherapy. Please mark below which of these 2 options applies to this patient:

• the patient received neoadjuvant chemotherapy as above and the post-surgical pathology revealed residual invasive breast carcinoma in the breast and/or resected lymph nodes which is confirmed as pathological high grade Or
• the patient received adjuvant chemotherapy as above with a pre-chemotherapy pathological demonstration of positive sentinel lymph node/s

8. The patient has completed definitive local treatment for the breast cancer (this includes any radiotherapy).
9. The patient is ideally 8 weeks or less but no more than 12 weeks from the date of the last treatment (surgery, chemotherapy, radiotherapy).

Note

Note: patients must be a minimum of 2 weeks after completion of radiotherapy and a minimum of 3 weeks since the last chemotherapy.

10. Adjuvant olaparib will be prescribed in combination with adjuvant hormone therapy (an aromatase inhibitor or an anti-oestrogen or a LHRH agonist). ”

Note

Note: adjuvant olaparib, adjuvant abemaciclib (BT form ABEM3), and adjuvant ribociclib (BT form RIB3) are not to be prescribed concurrently OR sequentially. If a patient meets the criteria for more than one of these options, the patient and clinician must decide which ONE of the THREE options are to be used.”

11. The patient has an ECOG performance status of either 0 or 1.

Note

Note: a patient with a performance status of 2 or more is not eligible for Olaparib.

12. Adjuvant olaparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or for a total treatment duration of 1 calendar year as measured from the date of commencing adjuvant olaparib.
13. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
14. Olaparib is to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 08 August 2023

Additional information

Form version: er1.2

CDF Managed Access: NA

NICE Technology Appraisal: TA886 (10 May 2023)

Current Form Version

Note

The data on this page was produced using version 1.380 of the CDF list, downloaded from NHS England’s website on 25 December 2025 at 11:00.

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.