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PHESGO® (pertuzumab/trastuzumab)

Click for Prescribing Information and details of enhanced pregnancy prevention programme for relevant products: PHESGO, Kadcyla (trastuzumab emtansine), Herceptin SC (trastuzumab), Herceptin IV, PERJETA (pertuzumab).

In HER2+ eBC, PHESGO is indicated for use in combination with chemotherapy in:1

  • The neoadjuvant treatment of adult patients with HER2+, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence​
  • The adjuvant treatment of adult patients with HER2+ eBC at high risk of recurrence​

In HER2+ mBC, PHESGO is indicated for use in combination with docetaxel for adult patients with HER2+ metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.1
When patients need the benefits of dual HER2 blockade and a regimen built for day-to-day living, choose PHESGO1–3
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Dual HER2 blockade is the standard of care for eligible patients across early and metastatic HER2+ BC4–9
In HER2+ eBC, dual HER2 blockade is recommended as an option by NICE/SMC/ESMO for patients at high risk of recurrence4–6,9

*In the adjuvant setting, PHESGO should be administered for a total of 1 year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for eBC and regardless of the timing of surgery.1 †Treatment should include standard anthracycline- and/or taxane-based chemotherapy. PHESGO should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.1

 

Other treatment options are available.

NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to review and may be updated or withdrawn.

NICE accepts no responsibility for the use of its content in this publication.
Please consult the full guidance at www.nice.org.uk/guidance/ta569 for comprehensive details. Please see relevant Summary of Product Characteristics for further information.

 

 
Dual HER2 blockade is recommended as a first-line treatment option by NICE and SMC for eligible patients with HER2+ mBC7,9

NICE decisions relate to use within a treatment's marketing authorisation. 

 

*Both Kadcyla & T-DXd are funded in fast relapsers.

NICE/SMC guidance is prepared for the NHS. All guidance is subject to review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this material. This information is intended as a summary of the NICE guidance. Please consult the full guidance at www.nice.org.uk for comprehensive details. Not an exhaustive representation of potential treatment options. Always refer to individual product prescribing information and local treatment guidelines before prescribing.
PHESGO offers dual HER2 blockade with the convenience of subcutaneous administration1–3

PHESGO is a fixed-dose combination of pertuzumab-trastuzumab in one vial for subcutaneous use given every 3 weeks.1
  • In patients receiving a taxane, PHESGO should be administered prior to the taxane​1
  • Patients should be observed for injection-related reactions and hypersensitivity reactions. Observation period should start following administration of PHESGO and be completed prior to any subsequent administration of chemotherapy1
  • The injection site should be alternated between the left and right thigh1​

Once pertuzumab-based therapy has been safely established, the physician may determine the suitability of administration of PHESGO outside of the clinical setting (e.g. at home) by a healthcare professional (see SmPC section 4.4).1
PHESGO has a non-inferior PK profile to IV pertuzumab-trastuzumab, delivering a comparable efficacy and safety profile2

FeDeriCa was a non-inferiority Phase 3 study assessing the PK, efficacy and safety of PHESGO vs pertuzumab IV-trastuzumab IV in HER2+ eBC.2

Figure adapted from Tan AR, et al. Lancet Oncol. 2021;22(1):85–97.

Key inclusion criteria2

Aged 18 years or older; Operable, locally advanced, or inflammatory HER2+ (IHC 3+ or in situ hybridisation-positive) stage II–IIIC BC with a primary tumour more than 2 cm in diameter, or N+ disease; ECOG performance status 0–1; LVEF ≥55% (by echocardiography or multiple-gated acquisition scan).

Key exclusion criteria2

Previous systemic therapy for treatment or prevention of breast cancer, or radiotherapy for cancer; serious cardiac condition; impaired liver function; inadequate renal or bone marrow function.

Dosing schedule2

Neoadjuvant chemotherapy regimens

  • Four ddAC cycles (doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² q2w, with granulocyte colony-stimulating factor as needed according to local guidelines) followed by paclitaxel 80 mg/m² qw for 12 weeks
  • Four AC cycles (doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² q3w) followed by four docetaxel cycles 75–100 mg/m² q3w
  • The choice between chemotherapy regimens was at the investigator’s discretion before randomisation

Neoadjuvant HER2 targeted therapy regimens

  • Pertuzumab loading dose was 840 mg, followed by 420 mg q3w, plus trastuzumab loading dose if needed was 8 mg/kg followed by 6 mg/kg IV q3w
  • PHESGO loading dose was pertuzumab 1,200 mg/trastuzumab 600 mg in 15 mL, followed by pertuzumab 600 mg/trastuzumab 600 mg in 10 mL q3w
  • The choice of chemotherapy was due to an anthracycline and a taxane being given for eight cycles with pertuzumab plus trastuzumab, starting on the fifth cycle, whereas docetaxel plus carboplatin would be given for six cycles with pertuzumab plus trastuzumab, starting with the first cycle

Adjuvant setting

  • After completion of the neoadjuvant regimen, patients underwent surgery, followed by a further 14 IV or SC cycles (maximum total of 18) of HER2-targeted therapy
PHESGO has a non-inferior PK profile vs IV pertuzumab–trastuzumab2

Figure adapted from Tan AR, et al. Lancet Oncol. 2021;22(1):85–97.

*Per protocol PK population: this population includes only patients who adhered to the pre-specified criteria for the schedule of PK assessments.2

The observed lower limits of the two-sided 90% CIs for the GMR of Cycle 7 serum Ctrough (SC versus IV) were above the pre-specified threshold of 0.8.2
PHESGO has a similar efficacy profile to IV pertuzumab–trastuzumab1,2,22

Figure adapted from Tan AR, et al. Lancet Oncol. 2021;22(1):85–97.
  • The long-term efficacy of PHESGO was similar to that of IV pertuzumab–trastuzumab at 4 year follow-up, with comparable rates of IDFS (88.5% [95% CI, 84.3–92.7] vs 89.6% [95% CI, 85.5–93.7]) and OS (94.1% [95% CI, 91.1–97.1] vs 95.5% [95% CI, 92.9–98.1]) observed in each treatment arm22
  • Patients treated with PHESGO achieved almost identical tpCR rates compared to IV pertuzumab–trastuzumab and similar clinical response rates (83% vs 85%)2
PHESGO offers a generally well-tolerated safety profile, similar to IV pertuzumab–trastuzumab1​,2

*LVEF decline in the neoadjuvant setting (when treatments concomitantly administered with chemotherapy); similar incidence of LVEF decline reported in the adjuvant setting (when PHESGO is administered alone).1​ †In the adjuvant setting, PHESGO should be administered for a total of 1 year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first), as part of a complete regimen for early breast cancer and regardless of the timing of surgery. Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
PHESGO should start on Day 1 of the first taxane-containing cycle and should continue even if chemotherapy is discontinued.​1
Most patients prefer fixed-dose SC delivery with PHESGO vs IV pertuzumab-trastuzumab3

PHranceSCa assessed patient preference for the fixed-dose combination of pertuzumab-trastuzumab for SC injection in patients with HER2+ eBC.3

Figure adapted from O’Shaughnessy J, et al. Eur J Cancer. 2021;152:223–32.

Key inclusion criteria3

Aged 18 years or older; Histologically confirmed HER2+ (locally confirmed IHC 3+ and/or in situ hybridisation-positive) inflammatory, locally advanced or eBC; completed neoadjuvant P-H and chemotherapy and had subsequently undergone surgery for BC; ECOG performance status of 0–1; LVEF ≥55% (by echocardiography or multiple-gated acquisition scan).

Key exclusion criteria3

Previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy [selective oestrogen receptor modulators, aromatase inhibitors] and anti-tumour vaccines) for treatment/prevention of BC, except neoadjuvant P, H and chemotherapy for current BC; serious cardiac illness/medical conditions; impaired/inadequate organ/bone marrow function.

Dosing schedule3

  • Pertuzumab IV loading dose if needed was 840 mg, followed by 420 mg q3w; trastuzumab IV loading dose if needed was 8 mg/kg, followed by 6 mg/kg q3w
  • PHESGO SC loading dose if needed was pertuzumab 1,200 mg/trastuzumab 600 mg in 15 mL, followed by pertuzumab 600 mg/trastuzumab 600 mg in 10 mL q3w
  • Loading doses were only required for patients who had ≥6 weeks since their last neoadjuvant dose of pertuzumab–trastuzumab at study entry, or had ≥6 weeks since their last study treatment during the study
  • Maintenance doses were used for subsequent administrations or dose delays <6 weeks

*HCPs' perceptions of time indicated that for 140/160 patients (87.5%), PHESGO SC was quicker than IV administration from preparation start to administration completion.3
Dual HER2 blockade has a well-characterised safety profile1

For patients treated with PHESGO or IV pertuzumab-trastuzumab and chemotherapy across neoadjuvant, adjuvant and metastatic settings:​1

  • The most common adverse reactions (≥30%) were alopecia, diarrhoea, nausea, anaemia, asthenia and arthralgia
  • The most common SAEs (≥1%) were febrile neutropenia, cardiac failure, pyrexia, neutropenia, neutropenic sepsis, neutrophil count decreased and pneumonia

The safety profile of PHESGO was overall consistent to the known safety profile of IV pertuzumab-trastuzumab, with an additional ADR of injection site reaction (15.3% vs 0.4%)1
Summary of ADRs in patients treated with pertuzumab, trastuzumab in pivotal clinical trials,*,† and in the post-marketing setting‡1

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

*Shows pooled data from the overall treatment period in CLEOPATRA (data cut off 11 February 2014; median number of cycles of pertuzumab was 24); and from the neoadjuvant treatment period in NEOSPHERE (median number of cycles of pertuzumab was 4, across all treatment arms) and TRYPHAENA (median number of cycles of pertuzumab was 3–6 across treatment arms); from the treatment period of APHINITY (median number of cycles of pertuzumab was 18) and from the overall treatment period of FeDeriCa (median number of cycles of PHESGO was 18). †Shows PHESGO data from the overall treatment period of FeDeriCa (median number of cycles of PHESGO was 18) ‡ADRs reported in the post marketing setting of pertuzumab and trastuzumab IV. §Including ADRs with a fatal outcome have been reported. For the overall treatment period across the 5 studies (CLEOPATRA, NEOSPHERE, TRYPHAENA, APHINITY, FeDeriCa). The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies. #No events of Interstitial lung disease were reported in the FeDeriCa study but these events have been observed with trastuzumab. ||Observed with PHESGO only (subcutaneous administration related). The higher frequency observed in the adjuvant phase is related to a longer period of treatment when PHESGO is administered as monotherapy.

Please see the SmPC for further details prior to initiating therapy.
 

Left ventricular dysfunction (including congestive heart failure)​

  • Decreases in LVEF have been reported with medicinal products that block HER2 activity, including pertuzumab and trastuzumab. The incidence of symptomatic left ventricular systolic dysfunction (LVD [congestive heart failure]) was higher in patients treated with pertuzumab in combination with trastuzumab and chemotherapy compared to trastuzumab and chemotherapy. In the adjuvant setting, the majority of cases of symptomatic heart failure reported were in patients who received anthracycline-based chemotherapy. Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of LVEF declines based on studies with intravenous pertuzumab in combination with trastuzumab and chemotherapy
  • Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of PHESGO with an anthracycline
  • Assess LVEF prior to initiation of PHESGO and at regular intervals during treatment (e.g. once during neoadjuvant treatment and every 
12 weeks in the adjuvant and metastatic setting) to ensure that LVEF is within normal limits. If the LVEF has declined as indicated below and has not improved, or has declined further at the subsequent assessment, discontinuation of PHESGO should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks

 

Dose modification for left ventricular dysfunction

  • PHESGO should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure. PHESGO should be discontinued if symptomatic heart failure is confirmed

 

Patients with metastatic breast cancer

  • Patients should have a pre-treatment LVEF of ≥50 %. PHESGO should be withheld for at least 3 weeks for:
    • a drop in LVEF to less than 40%
    • a LVEF of 40–45% associated with a fall of ≥10% points below pre-treatment value
  • PHESGO may be resumed if the LVEF has recovered to >45%, or to 40–45% associated with a difference of <10% points below pre-treatment values

 

Patients with early breast cancer

  • Patients should have a pre-treatment LVEF of ≥55% (≥50% after completion of the anthracycline component of chemotherapy, if given).
  • PHESGO should be withheld for at least 3 weeks for a drop in LVEF to less than 50 % associated with a fall of ≥10% points below pre-treatment values
  • PHESGO may be resumed if the LVEF has recovered to ≥50% or to a difference of <10% points below pre-treatment values

 

Injection-related reactions/infusion-related reactions

  • PHESGO has been associated with injection-related reactions. Close observation of the patient during and for 30 minutes after administration of the loading dose and during and for 15 minutes following the administration of the maintenance dose of PHESGO is recommended

 

Hypersensitivity

  • Patients should be observed closely for hypersensitivity reactions. Severe hypersensitivity reactions, including anaphylaxis and events with fatal outcomes, have been observed with pertuzumab in combination with trastuzumab and chemotherapy
  • PHESGO is contraindicated in patients with known hypersensitivity to pertuzumab, trastuzumab or to any of its excipients

 

Febrile neutropenia​

  • Patients treated with PHESGO in combination with a taxane are at increased risk of febrile neutropenia
  • Patients treated with intravenous pertuzumab in combination with trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment

 

Diarrhoea

  • PHESGO may elicit severe diarrhoea. Diarrhoea is most frequent during concurrent administration with taxane therapy. Elderly patients 
(≥65 years) have a higher risk of diarrhoea compared with younger patients (<65 years)

 

Pulmonary events​

  • Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting. These events have occasionally been fatal. In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency also have been reported. Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy. These events may occur as part of an infusion-related reaction or with a delayed onset.

 

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Indications and prescribing information

 

In HER2+ eBC, PHESGO is indicated for use in combination with chemotherapy in:

  • The neoadjuvant treatment of adult patients with HER2+, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence​
  • The adjuvant treatment of adult patients with HER2+ eBC at high risk of recurrence​

 

In HER2+ mBC, PHESGO is indicated for use in combination with docetaxel for adult patients with HER2+ metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

 

PHESGO Prescribing Information and details of the enhanced pregnancy prevention programme

Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2+ eBC who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.

 

Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2+, unresectable locally advanced or mBC who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.

 

Kadcyla Prescribing Information

Product information

Herceptin is indicated for the treatment of adult patients with HER2+ eBC:

  • Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)
  • Following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel
  • In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin
  • In combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter

 

Herceptin is indicated for the treatment of adult patients with HER2+ mBC:

  • As monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments
  • In combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable
  • In combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
  • In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone receptor-positive mBC, not previously treated with trastuzumab

 

Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

 

Herceptin SC Prescribing Information

In eBC, PERJETA is indicated for use in combination with trastuzumab and chemotherapy in:

  • The neoadjuvant treatment of adult patients with HER2+, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence
  • The adjuvant treatment of adult patients with HER2+ eBC at high risk of recurrence

 

In mBC, PERJETA is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2+ metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

 

PERJETA Prescribing Information
Abbreviations:

AC, doxorubicin + cyclophosphamide; ADR, adverse drug reaction; BC, breast cancer; C, cycle; CI, confidence interval; 
Ctrough, serum trough concentration; D, day; ddAC, dose-dense doxorubicin + cyclophosphamide; DRFI, distant relapse-free interval; eBC, early breast cancer; ECOG, Eastern Cooperative Oncology Group; EFS, event-free survival; ESMO, European Society for Medical Oncology; GI, gastrointestinal; GMR, geometric mean ratio; H, trastuzumab; HCP, healthcare professional; 
HER2, human epidermal growth factor receptor 2; HR, hormone receptor; IDFS, invasive disease-free survival; 
IHC, immunohistochemistry; IV, intravenous; LVD, left ventricular dysfunction; LVEF, left ventricular ejection fraction; mBC, metastatic breast cancer; MedDRA, Medical Dictionary for Regulatory Activities; N, node; NICE, National Institute for Health and Care Excellence; NYHA, New York Heart Association; OS, overall survival; P, pertuzumab; pCR, pathological complete response; PK, pharmacokinetics; PPQ, Patient Preference Questionnaire; qw, every week; q2w, every 2 weeks; q3w, every 3 weeks; 
SAE, serious adverse event; SC, subcutaneous; SLNB, sentinel lymph node biopsy; SmPC, Summary of Product Characteristics; TASQ, Therapy Administration Satisfaction Questionnaire; tpCR, total pathological complete response.
References:
  1. Roche. PHESGO. Summary of Product Characteristics. 
  2. Tan R, et al. Lancet Oncol. 2021;22(1):85–97.
  3. O’Shaughnessy J, et al. Eur J Cancer. 2021;152:223–32.
  4. Loibl S, et al. Ann Oncol. 2024;35(2):159–82.
  5. National Institute for Health and Care Excellence (NICE). Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer. TA424. December 2016. https://www.nice.org.uk/guidance/ta424. Accessed September 2026.
  6. National Institute for Health and Care Excellence (NICE). Pertuzumab for adjuvant treatment of HER2-positive early-stage breast cancer. TA569. March 2019. Available at: https://www.nice.org.uk/guidance/ta569. Accessed September 2026.
  7. National Institute for Health and Care Excellence (NICE). Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer. TA509. March 2018. www.nice.org.uk/guidance/ta509. Accessed September 2026.
  8. Swain SM, et al. Lancet Oncol. 2020;21(4):519–530.
  9. Scottish Medicines Consortium (SMC). Pertuzumab and trastuzumab (PHESGO). SMC2364. July 2021. Available at: https://scottishmedicines.org.uk/medicines-advice/pertuzumab-and-trastuzumab-phesgo-abb-smc2364/. Accessed September 2026.
  10. Roche. Kadcyla Summary of Product Characteristics. 
  11. National Institute for Health and Care Excellence (NICE). Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer. TA632. June 2020. Available at: https://www.nice.org.uk/guidance/ta632. Accessed September 2026.
  12. Scottish Medicines Consortium (SMC). SMC2298. November 2020. Available at: https://scottishmedicines.org.uk/medicines-advice/trastuzumab-emtansine-kadcylafull- smc2298/. Accessed September 2026.
  13. Roche. Herceptin Summary of Product Characteristics. 
  14. National Institute for Health and Care Excellence (NICE). Early and locally advanced breast cancer: diagnosis and management. NG101. July 2018. Available at: https://www.nice.org.uk/guidance/ng101. Accessed September 2026.
  15. Scottish Medicines Consortium (SMC). SMC928/13. January 2014. Available at: https://scottishmedicines.org.uk/medicines-advice/trastuzumab-herceptinfullsubmission- 92813/. Accessed September 2026.
  16. National Institute for Health and Care Excellence (NICE). Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane. TA458. July 2017. Available at: www.nice.org.uk/guidance/ta458. Accessed September 2026.
  17. National Institute for Health and Care Excellence (NICE). Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments. TA862. February 2023. Available at: https://www.nice.org.uk/guidance/ta862. Accessed September 2026.
  18. National Institute for Health and Care Excellence (NICE). Guidance on the use of trastuzumab for the treatment of advanced breast cancer. TA34. March 2002. Available at: www.nice.org.uk/guidance/ta34. Accessed September 2026.
  19.  National Institute for Health and Care Excellence (NICE). Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies. April 2022. Available at: https://www.nice.org.uk/guidance/ta786. Accessed September 2026.
  20. National Institute for Health and Care Excellence (NICE). Advanced breast cancer: diagnosis and treatment. CG81. Available at: https://www.nice.org.uk/guidance/cg81/chapter/Systemic-anticancer-therapy. Accessed September 2026.
  21. Roche. PERJETA. Summary of Product Characteristics. 
  22. Jackisch C, et al. ESMO Open. 2026;11(8):108328.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. You can also report via the free Yellow Card app available from the Apple App Store or Google Play Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554. Adverse reactions should be reported by brand name and batch number.
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