Trastuzumab emtansine MONOTHERAPY [TRA2]

As adjuvant therapy for patients with HER2-positive early breast cancer who have residual invasive disease following the combination of taxane-based and HER2-targeted neoadjuvant systemic therapy and surgery where the following criteria have been met:

1. This application for trastuzumab emtansine as adjuvant chemotherapy is being made by and the first cycle of adjuvant trastuzumab emtansine will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has histologically documented breast cancer which is HER2 3+ by immunohistochemistry and/or has a ratio of ≥2.0 by in situ hybridisation.
3. The patient has been diagnosed with early breast cancer and this has been adequately excised.
4. Prior to neoadjuvant chemotherapy the patient had clinical stage T1-T4, nodal stage N0-3 and metastasis stage M0 disease.
5. The patient has been previously treated with at least 16 weeks of neoadjuvant cytotoxic chemotherapy which incorporated a minimum of at least 9 weeks of taxane-based chemotherapy and 9 weeks of HER2-targeted therapy unless entered into the ROSCO trial , or was entered into the 3 Pillars trial, or was considered potentially eligible for the HER2 RADiCAL trial. Please tick below which option applies:

• At least 16 weeks of neoadjuvant cytotoxic chemotherapy which incorporated a minimum of at least 9 weeks of taxane-based chemotherapy and at least 9 weeks of HER2-targeted therapy or
• The patient was enrolled into the ROSCO trial (UKCRN Study ID19069) and was treated with 4 cycles of neoadjuvant chemotherapy plus trastuzumab with or without pertuzumab but did not achieve a pathological complete response and has therefore received 4 cycles of adjuvant chemotherapy with trastuzumab with or without pertuzumab or
• The patient was enrolled into the 3 Pillars clinical trial and was treated with palbociclib, tucatinib and trastuzumab in the neoadjuvant setting, completing at least 18 weeks of treatment prior to surgery, therefore having received at least 6 doses of subcutaneous trastuzumab or
• The patient was potentially eligible for the HER2 RADiCAL trial (UKCRN Study ID131362) and was treated with at least 12 weeks of taxane-based chemotherapy with trastuzumab and pertuzumab but did not achieve a pathological complete response and has therefore received at least 9 weeks of anthracycline-based adjuvant treatment

6. The patient has documented residual disease after neoadjuvant chemotherapy and HER2-directed treatment and that one of the following scenarios applies to this patient as to the documented residual invasive disease after completion of neoadjuvant therapy and surgery:

• the patient had residual invasive disease in the breast only or
• the patient had residual invasive disease in the lymph nodes only or
• the patient had residual invasive disease in both the breast and lymph nodes.

Note

Note: trastuzumab emtansine as adjuvant treatment is only NICE-recommended and NHS England-commissioned in patients with documented residual disease invasive disease after completion of neoadjuvant chemotherapy and surgery.

7. Trastuzumab emtansine is the only HER2-directed therapy to be given after surgery i.e. no adjuvant trastuzumab/pertuzumab has been administered since surgery with the exception of patients enrolled in the ROSCO clinical trial. It is acknowledged that post-surgery patients may have received one cycle of adjuvant pertuzumab and trastuzumab whilst awaiting the pathology results to confirm the status of axillary lymph node involvement and any residual disease
8. A maximum of 14 cycles of trastuzumab emtansine will be administered as adjuvant therapy unless there is evidence of progressive disease or unacceptable toxicity or withdrawal of patient consent. If trastuzumab emtansine has to be discontinued early, and without disease progression, completion of the intended adjuvant treatment duration up to 14 cycles of adjuvant HER2-directed therapy can be done with trastuzumab (if lymph node negative) or trastuzumab plus pertuzumab (if lymph node positive).

Note

Note: A maximum of 18 cycles of HER2-directed therapy (neoadjuvant plus adjuvant) are funded provided all other criteria are met.

9. The patient has an ECOG performance status of 0 or 1.
10. Where a treatment break of more than 6 weeks beyond the expected cycle length is needed, a treatment break approval form will be completed to restart treatment, which MUST be approved before treatment is recommenced.
11. Trastuzumab emtansine will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 08 September 2020

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA632 (10 June 2020)

Current Form Version

Note

The data on this page was produced using version 1.390 of the CDF list, downloaded from NHS England’s website on 25 March 2026 at 18:00.

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.

Older Form Versions

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• TRA2_prior_to_cdf_1.361
• TRA2_prior_to_cdf_1.390