Atezolizumab in combination with nab- paclitaxel [ATE6]

For treating untreated PD-L1-positive, triple negative, unresectable, locally advanced metastatic breast cancer for patients whose tumours express PD-L1 at a level of 1% or more where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with atezolizumab in combination with nab-paclitaxel will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies and hepatitis and skin toxicities.
3. The patient has a histologically- or cytologically-confirmed diagnosis of locally advanced and unresectable or metastatic breast cancer.
4. The patient’s breast cancer has had receptor analysis performed and this is negative for all of the following: the HER2 receptor, oestrogen receptor and progesterone receptor i.e. the patient has triple negative disease.
5. The patient’s tumour has been tested for PD-L1 expression and demonstrates PD-L1 expression of 1% or more by an approved and validated test. Note: the measurement used for PD-L1 testing in the registration trial was defined as the presence of discernible PD-L1 staining of any intensity in tumour infiltrating immune cells covering 1% or more of the tumour area occupied by tumour cells, associated intra-tumoural and contiguous peri-tumoural desmoplastic stroma. Please document the actual PD-L1 expression below: PD-L1 expression: _________
6. The patient has had no prior systemic therapy for the unresectable and locally advanced or metastatic breast cancer indication.
7. Either the patient has never had any prior treatment with anti-PD-L1/PD-1 therapy for the breast cancer or the only previous anti-PD-1/PD-L1 treatment that the patient has received was with prior neoadjuvant and adjuvant therapy and there was no disease progression during such treatment and for at least 12 months after completion of anti-PD-1/PD-L1 therapy. Please mark below which of these clinical scenarios applies to this patient:

• the patient has never had any prior treatment with anti-PD-1/PD-L1 therapy for the breast cancer or
• the only previous anti-PD-1/PD-L1 treatment that the patient has received was prior neoadjuvant and adjuvant therapy and there was no disease progression during such treatment and for at least 12 months after completion of anti- PD-1/PD-L1 therapy or Please document in the box below the time gap in months between completion of the previous neoadjuvant and adjuvant anti-PD-1/PD-L1 immunotherapy and the first diagnosis of disease relapse. If the patient has never had such immunotherapy, please type ‘n/a’. Time gap in months after the completion of previous neoadjuvant and adjuvant anti-PD-1/PD-L1 immunotherapy and the first diagnosis of disease relapse: __________

8. The patient is eligible for taxane monotherapy as 1st line treatment for locally advanced/metastatic breast cancer and that only the combination of atezolizumab plus nab-paclitaxel is being used as 1st line treatment.
9. The patient will be treated with either intravenous atezolizumab 840mg on days 1 and 15 or 1680mg on day 1 of a 28 day treatment cycle in combination with chemotherapy and in the absence of disease progression, treatment with these doses and schedules of atezolizumab will continue until disease progression or unacceptable toxicity or withdrawal of patient consent, whichever occurs first. Note: there is no formal stopping rule for atezolizumab in benefitting patients as regards the duration of treatment with atezolizumab. Note: Atezolizumab may be continued as a single agent if nab-paclitaxel has to be discontinued due to toxicity in which case atezolizumab may be given as monotherapy either subcutaneously at a dose of 1875mg every 3 weeks or intravenously at a dose of 1200mg every 3 weeks or 1680 mg every 4 weeks.
10. The patient will be treated with nab-paclitaxel at an initial dose of 100mg/m² on days 1, 8 and 15 of a 28 day treatment cycle with a target of at least 6 cycles and with no maximum number of cycles as long as in the absence of disease progression, unacceptable toxicity or withdrawal of patient consent. It is important to note that this dose and schedule of nab-paclitaxel is not currently the licensed dose and schedule in metastatic breast cancer.
11. The patient has an ECOG performance status (PS) of 0 or 1.
12. The patient has no symptomatically active brain metastases or leptomeningeal metastases.
13. A formal medical review as to how atezolizumab and nab-paclitaxel are being tolerated and whether treatment with the combination of atezolizumab and nab-paclitaxel should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
14. Where a treatment break of more than 12 weeks beyond the expected 4 weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
15. Atezolizumab and nab-paclitaxel will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 31 July 2020

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA639 (01 July 2020)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.