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Monoclonal Antibodies

Home Administration of Pertuzumab + Trastuzumab for Breast Cancer (ProHer Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)

Awards & highlights

ProHer Trial Summary

This trial is testing whether patients prefer getting a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use at home or in the hospital.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include allergic reactions related to drug components or murine proteins; infusion-related reactions; heart problems due to agents like trastuzumab affecting cardiac function; potential liver issues from impaired liver function exclusion criteria; as well as general chemotherapy-associated risks such as fatigue, nausea, hair loss.

ProHer Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My surgery wound from breast cancer has healed well enough to start treatment within 9 weeks after my last therapy.

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I had surgery after initial treatment and my cancer was completely removed, as confirmed by tests.

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My breast cancer is HER2 positive, confirmed by a lab test.

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I agree to not have unprotected sex or donate sperm for 7 months after my last treatment dose.

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I agree to have surgery to remove my breast or part of it, including lymph nodes, after initial treatment.

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The skin where I'll get injections is healthy.

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I have stage II-IIIC HER2+ breast cancer that has not spread far.

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My primary tumor is larger than 2cm, or I have cancer in my lymph nodes.

ProHer Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose post-surgery until the last dose of adjuvant treatment (up to 1.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Who Preferred the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting, Question 1 of the Patient Preference Questionnaire

Secondary outcome measures

Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Administering Treatment

Duration of Treatment Administration Activities, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Neoadjuvant Phase Administering Treatment

Duration of Treatment Preparation, According to Healthcare Professionals' Responses to Question 1 of the HCPQ - Adjuvant Phase Drug Preparation Area

+25 more

ProHer Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm E: Adjuvant Trastuzumab EmtansineExperimental Treatment1 Intervention

Participants with pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy and surgery will enter Arm E to receive trastuzumab emtansine for 14 cycles. Trastuzumab emtansine will be administered IV in the hospital as per prescribing information.

Group II: Arm D: Adjuvant PH FDC SC at Home, Then in HospitalExperimental Treatment1 Intervention

During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm D will receive 3 cycles of PH FDC SC in the home setting and then 3 cycles of PH FDC SC in the hospital. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period.

Group III: Arm C: Adjuvant PH FDC SC in Hospital, Then at HomeExperimental Treatment1 Intervention

During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm C will receive 3 cycles of PH FDC SC in the hospital and then 3 cycles of PH FDC SC in the home setting. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period.

Group IV: Arm B: PH FDC SC Plus Investigator's Choice of ChemotherapyExperimental Treatment4 Interventions

During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with the fixed dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH FDC SC will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH FDC SC will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).

Group V: Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of ChemotherapyExperimental Treatment5 Interventions

During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with pertuzumab and trastuzumab intravenously (PH IV) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH IV will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH IV will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Investigator's Choice of Chemotherapy

2021

Completed Phase 2

~260

Pertuzumab IV

2018

Completed Phase 3

~660

Trastuzumab IV

2018

Completed Phase 3

~660

Trastuzumab Emtansine

2016

Completed Phase 3

~5630

Surgery

2000

Completed Phase 3

~2550

Radiotherapy

2017

Completed Phase 3

~2610

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,707 Total Patients Enrolled

160 Trials studying Breast Cancer

91,467 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,155 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Media Library

Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05415215 — Phase 3

Breast Cancer Research Study Groups: Arm C: Adjuvant PH FDC SC in Hospital, Then at Home, Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of Chemotherapy, Arm B: PH FDC SC Plus Investigator's Choice of Chemotherapy, Arm D: Adjuvant PH FDC SC at Home, Then in Hospital, Arm E: Adjuvant Trastuzumab Emtansine

Breast Cancer Clinical Trial 2023: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) Highlights & Side Effects. Trial Name: NCT05415215 — Phase 3

Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415215 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA's decision pending on the Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)?

"The safety of Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) has been estimated to be a 3. This is due to the fact that this is a Phase 3 trial, signifying that there is available data which supports efficacy as well as multiple rounds of data which support safety."

Answered by AI

Is this a closed or open clinical trial?

"That is right, the trial is currently ongoing and is looking for 330 patients from 3 locations, as stated on clinicaltrials.gov. The trial was posted on July 5th, 2020 and was last updated on October 21st, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

2022. "A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05415215.

All > Inflammatory Breast Cancer