Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)

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P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --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 Withdrawn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

P2, N=240, Not yet recruiting, German Cancer Research Center | Trial completion date: Dec 2029 --> Dec 2030 | Trial primary completion date: Apr 2029 --> Mar 2030

P2, N=185, Recruiting, Baylor Breast Care Center | Not yet recruiting --> Recruiting

P3, N=500, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Jun 2023

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

Preliminary safety data indicated that the study treatments were overall well tolerated. Together with previous findings showing comparable efficacy and safety profiles and Pts preference of PH FDC SC versus P-IV+H-IV in (neo)adjuvant settings, these results encourage the use of PH FDC SC for dual blockade treatments.

Efficacy data are immature but show high IDFS and OS rates at 3 years. For the latest information on IDFS data, please consult the Poster.

P2, N=240, Not yet recruiting, German Cancer Research Center | Initiation date: Dec 2022 --> May 2023

P2, N=25, Not yet recruiting, Mayo Clinic

P2, N=185, Not yet recruiting, Baylor Breast Care Center | Trial completion date: Jan 2028 --> Sep 2029 | Trial primary completion date: Oct 2025 --> Jun 2027

P2, N=170, Recruiting, German Breast Group | Not yet recruiting --> Recruiting | Trial completion date: Jun 2026 --> Jan 2027 | Initiation date: Jun 2022 --> Jan 2023 | Trial primary completion date: Mar 2026 --> Oct 2026

PH IV and PH FDC SC were well tolerated, with few grade ≥3 anaphylaxis/hypersensitivity events reported with PH IV and no grade ≥3 related events with PH FDC SC. Most events occurred during chemotherapy.

P1/2, N=510, Recruiting, Hoffmann-La Roche | Trial completion date: Apr 2027 --> Oct 2026 | Trial primary completion date: Oct 2026 --> Apr 2026

P2, N=160, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

In the induction phase, pts will receive 4–6 PH FDC SC cycles (1200 mg P/600 mg H in the first cycle, followed by 600/600 mg every 3 weeks) + a taxane (investigator choice of docetaxel/paclitaxel)...ET (aromatase inhibitor/tamoxifen) will be allowed in the PH FDC SC-only arm...CONTACT INFORMATION For more information or to refer a patient, email global.rochegenentechtrials@roche.com or call 1-888-662-6728 (USA only). Clinicaltrials.gov number: NCT05296798.

Methods Pts with operable or locally advanced/inflammatory disease (stage II–IIIC; primary tumour >2cm/node-positive) were randomised 1:1 to four doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) cycles every 3 weeks (q3w), then four docetaxel (D; 75–100 mg/m2) cycles q3w. No new safety signals were identified. This suggests PH FDC SC may be a viable treatment option for Chinese pts.

P2, N=240, Not yet recruiting, German Cancer Research Center | Initiation date: Jul 2022 --> Dec 2022