347 Participants Needed

Home Administration of Pertuzumab + Trastuzumab for Breast Cancer

(ProHer Trial)

Recruiting at 65 trial locations
RS
Overseen ByReference Study ID Number: MO43110 https://forpatients.roche.com/
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a combination of two drugs, pertuzumab and trastuzumab, given as an injection under the skin. It focuses on patients with a specific type of breast cancer. The goal is to see if patients prefer getting this treatment at home or in the hospital. These drugs work by attaching to a protein on cancer cells to stop them from growing. Pertuzumab was originally developed independently from trastuzumab and later found to work well together when combined with trastuzumab.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the combination of pertuzumab and trastuzumab safe for human use?

The combination of pertuzumab and trastuzumab, whether given intravenously or as a fixed-dose subcutaneous injection, has been studied for safety in patients with HER2-positive breast cancer. Serious side effects were similar between the subcutaneous and intravenous forms, and most patients preferred the subcutaneous method. Additionally, the combination with trastuzumab emtansine (T-DM1) showed no significant drug interaction issues, suggesting it is generally safe for human use.12345

What makes the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection unique for breast cancer treatment?

This treatment is unique because it combines two drugs, pertuzumab and trastuzumab, into a single injection that can be given under the skin in just 5-8 minutes, compared to the traditional intravenous method that takes 1-2.5 hours. This makes it more convenient for patients and reduces the time and resource burden on healthcare facilities.24567

What data supports the effectiveness of the drug for breast cancer?

The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) was shown to be as effective as the intravenous version in maintaining drug levels and achieving similar complete response rates in patients with HER2-positive early breast cancer. Additionally, most patients preferred the subcutaneous version due to its quicker administration time.24567

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with early or locally advanced/inflammatory HER2-positive breast cancer. Participants must have completed neoadjuvant therapy and surgery, not be pregnant or breastfeeding, agree to use contraception, and have no severe allergies to study drugs. They should not have metastatic cancer, uncontrolled diseases, recent thromboembolism without stable anticoagulation treatment, a history of other malignancies within the last 5 years (except certain treated cancers), or any condition that would make it unsafe for them to participate.

Inclusion Criteria

You tested negative for hepatitis B surface antigen (HBsAg) at the screening.
I am fully active or can carry out light work.
I have been screened for hepatitis B with specific antibody results.
See 14 more

Exclusion Criteria

I have an active liver disease such as hepatitis or autoimmune disorder.
I have a history of irregular heartbeats or factors that increase my risk.
I have a high risk for breast cancer and have taken medication to lower my risk.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pertuzumab and trastuzumab with chemotherapy options for 6 to 8 cycles, each cycle lasting 3 weeks

18-24 weeks

Adjuvant Treatment

Participants receive PH FDC SC treatment in a cross-over period between hospital and home settings, followed by continuation to complete 18 cycles of HER2-directed therapy

up to 54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
  • Pertuzumab IV
  • Trastuzumab Emtansine
  • Trastuzumab IV
Trial Overview The study tests patient preference for home versus hospital administration of a fixed-dose combination of Pertuzumab and Trastuzumab given subcutaneously after surgery in those with HER2-positive breast cancer. It also includes Investigator's Choice of Chemotherapy, IV forms of Pertuzumab and Trastuzumab, Trastuzumab Emtansine treatments along with necessary surgeries and radiotherapy.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Arm E: Adjuvant Trastuzumab EmtansineExperimental Treatment1 Intervention
Group II: Arm D: Adjuvant PH FDC SC at Home, Then in HospitalExperimental Treatment1 Intervention
Group III: Arm C: Adjuvant PH FDC SC in Hospital, Then at HomeExperimental Treatment1 Intervention
Group IV: Arm B: PH FDC SC Plus Investigator's Choice of ChemotherapyExperimental Treatment4 Interventions
Group V: Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of ChemotherapyExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

The novel fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PHESGO®) is non-inferior to the traditional intravenous (IV) administration in terms of drug levels and efficacy, with comparable total pathologic complete response rates (59.7% for PHESGO® vs 59.5% for IV).
PHESGO® can be administered in just 5-8 minutes, significantly reducing the time burden on patients and medical facilities compared to the 1-2.5 hours required for IV infusions, and 85% of patients preferred the subcutaneous option.
Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive breast cancer: A multidisciplinary approach.DuMond, B., Patel, V., Gross, A., et al.[2021]
Subcutaneous (SC) administration of the fixed-dose combination of pertuzumab and trastuzumab (PH FDC SC) for HER2-positive breast cancer shows significant time and resource savings compared to traditional intravenous (IV) administration, as evidenced by a systematic review of 72 studies.
The majority of studies indicated that SC administration not only reduces the time required for preparation and administration but also leads to cost savings by decreasing the healthcare professional time and resources needed, making it a more efficient option for treatment.
A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting.McCloskey, C., Ortega, MT., Nair, S., et al.[2023]
In a review of six studies involving 996 patients with HER2-positive breast cancer, the addition of pertuzumab to trastuzumab emtansine (T-DM1) ± taxane did not significantly improve objective response or clinical benefit rates compared to T-DM1 alone.
While the combination treatment was associated with increased risks of certain adverse events like diarrhea and rash, it also showed a decreased risk of thrombocytopenia, indicating a complex safety profile that requires careful monitoring.
Safety and efficacy of the addition of pertuzumab to T-DM1 ± taxane in patients with HER2-positive, locally advanced or metastatic breast cancer: a pooled analysis.Zhang, J., Li, J., Zhu, C., et al.[2022]

Citations

Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer. [2023]
Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive breast cancer: A multidisciplinary approach. [2021]
A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. [2023]
Safety and efficacy of the addition of pertuzumab to T-DM1 ± taxane in patients with HER2-positive, locally advanced or metastatic breast cancer: a pooled analysis. [2022]
Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. [2021]
Combination efficacy of pertuzumab and trastuzumab for trastuzumab emtansine-resistant cells exhibiting attenuated lysosomal trafficking or efflux pumps upregulation. [2021]
Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer. [2019]
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