Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)

P3, N=812, Recruiting, Hoffmann-La Roche | Trial completion date: Sep 2032 --> Dec 2030 | Trial primary completion date: Aug 2026 --> Mar 2027

P2, N=139, Terminated, Jules Bordet Institute | N=1065 --> 139 | Trial completion date: Mar 2029 --> Nov 2024 | Suspended --> Terminated | Trial primary completion date: Jun 2027 --> Nov 2024; Serious concerns on the slow recruitment of the study that impacts the robustness of the scientific rationale and the study financial provision. It aims to assess carefully the situation and to evaluate the potential solutions to overcome the issues.

P3, N=230, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2028 --> Jan 2028 | Trial primary completion date: Oct 2028 --> Oct 2026

This initiative demonstrated the ability to rapidly and effectively transition >95% of eligible breast cancer patients from separate IV trastuzumab and pertuzumab to a fixed combined SC formulation. Patient benefits included shorter administration appointments and a less invasive form of treatment, whereas healthcare system benefits included substantial savings in aseptic preparation time and chair time, and a meaningful increase in clinic capacity. The reported treatment-switch process provides a model that can be adopted by other centres wishing to implement similar treatment switches.

SC formulations of anti-HER2 monoclonal antibodies offer several advantages over IV counterparts, including shorter administration time, less need for IV access, and better resource utilization for treatment facilities. This review summarizes the clinical data supporting the use of SC trastuzumab and PH FDC SC injection in treating early-stage and metastatic HER2-positive breast cancer and highlights the benefits of SC injection compared to the IV formulations.

In this regard, we also found that the savings produced from switching from the traditional intravenous treatment to the subcutaneous one would allow EsSalud to afford full annual costs of 2 additional treatments, but without increasing their budget. This would cover 7% of the gap of 29 patients who do not have access to full treatment.

Patients received neoadjuvant treatment with taxanes and subcutaneous fixed dose combination pertuzumab and trastuzumab (P+T) for a total duration of 12 weeks followed by surgery. Adjuvant treatment was determined according to response at surgery: patients with a pathologic complete response (pCR, defined as pT0/Tis pN0) received adjuvant P+T for additional 14 cycles, while patients with residual disease received adjuvant trastuzumab emtansine (T-DM1) for 14 cycles... Neoadjuvant treatment with an anthracycline-free regimen in patients with HER2-positive, hormone receptor negative, node-negative early breast cancer resulted in a high rate of pCR. The majority of patients achieving pCR had the HER2-enriched PAM50 subtype.

P2, N=53, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting

P2, N=3791, Recruiting, American Society of Clinical Oncology | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Dec 2024 --> Jun 2026

P3, N=654, Active, not recruiting, Seagen Inc. | Trial completion date: Jun 2027 --> Oct 2027 | Trial primary completion date: Oct 2024 --> May 2025

P1, N=210, Recruiting, Suzhou Zanrong Pharma Limited | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2023 --> Oct 2025

P2, N=165, Recruiting, MedSIR | Not yet recruiting --> Recruiting

P3, N=654, Active, not recruiting, Seagen Inc. | Recruiting --> Active, not recruiting

P2, N=63, Not yet recruiting, Latin American Cooperative Oncology Group | Initiation date: Apr 2024 --> Jul 2024

P2, N=72, Not yet recruiting, Dana-Farber Cancer Institute

heredERA BC will address whether giredestrant plus dual HER2 blockade is superior to dual HER2 blockade alone, to inform the use of this combination in clinical practice for maintenance 1L treatment of patients with HER2+, ER+ LA/mBC.

P3, N=347, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Mar 2025

P2, N=393, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting

P2, N=25, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

P2, N=252, Completed, Genentech, Inc. | Active, not recruiting --> Completed

P2, N=3000, Recruiting, Oslo University Hospital | N=1000 --> 3000

P2, N=63, Not yet recruiting, Latin American Cooperative Oncology Group | Trial completion date: Jul 2031 --> Oct 2031 | Trial primary completion date: Jul 2026 --> Oct 2026

P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn

P2, N=25, Not yet recruiting, Mayo Clinic | Trial primary completion date: Aug 2024 --> Aug 2025

P2, N=165, Not yet recruiting, MedSIR

‡ ≥1/10,000 to <1/1,000. CI = confidence interval; H = trastuzumab; IV = intravenous; P = pertuzumab; PH FDC SC = pertuzumab, trastuzumab, and hyaluronidase-zzxf.

The current study will assess the efficacy and safety of maintenance inavolisib + fixed-dose combination of pertuzumab + trastuzumab for subcutaneous injection (PH FDC SC) after first-line induction treatment in patients with PIK3CA-mutated, HER2+, advanced BC (aBC). ACCRUAL Target randomization is ~230 patients; recruitment began in July 2023. CONTACT INFORMATION For more information or to refer a patient, email global.rochegenentechtrials@roche.com or call 1-888-662-6728 (USA only).

P3, N=330, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting

P1, N=151, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

P2, N=63, Not yet recruiting, Latin American Cooperative Oncology Group

The use of PH-FDC-SC for the treatment of patients with HER2-positive BC improves the efficiency of the Spanish hospitals by saving non-pharmacological costs and allowing an increase in hospital capacity.

In Chile, public reimbursement of anti-HER2 agents includes trastuzumab for all indications, pertuzumab for metastatic BC, and trastuzumab emtansine (TDM1) for adjuvant when residual disease. Regardless of the coverage fund by which Phesgo® treatment is financed, including Phesgo® in metastasis and neoadjuvant generates savings for the Chilean public health system. These come from improved clinical response due to neoadjuvant dual HER2-blockade and a cost-saving option over pertuzumab in metastasis.

This capacity tool demonstrates the impact of using different treatment options for HER2+ breast cancer on the hospital capacity and human resources customized to each hospital reality. The simulation demonstrated that PH FDC SC has potential to provide substantial timesavings for the pharmacy, the nurses and the patients due to its simpler preparation and considerably shorter duration of administration and observation periods. In conclusion, this capacity tool can inform hospitals about the value of different treatments besides efficacy and safety, demonstrating the impact on the hospital day-to-day management and on patients’ time.

P2, N=25, Not yet recruiting, Mayo Clinic | Initiation date: Sep 2023 --> Dec 2023

No abstract available

P2; Recruiting --> Suspended

DECRESCENDO (NCT04675827) is a large, multicenter, single-arm phase II trial in patients with HR-negative, HER2-positive, node-negative early BC evaluating a neoadjuvant pertuzumab and trastuzumab fixed-dose combination administered subcutaneously plus taxane-based chemotherapy followed by adjuvant treatment, adapted according to response to neoadjuvant therapy. The primary end point is the 3-year recurrence-free survival rate in patients with 'HER2-enriched' tumors and a pathological complete response. This flexible care substudy offers adjuvant treatment administration outside the hospital to some patients.

P1, N=25, Not yet recruiting, OHSU Knight Cancer Institute | Phase classification: P2 --> P1 | N=131 --> 25

P2, N=240, Recruiting, German Cancer Research Center | Not yet recruiting --> Recruiting

P2, N=25, Not yet recruiting, Mayo Clinic | Initiation date: Apr 2023 --> Sep 2023

P3, N=230, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting