What side effects are associated with this type of intervention?

Common side effects of HER2-targeted therapies like pertuzumab and trastuzumab include infusion-related reactions, diarrhea, fatigue, nausea, and neutropenia. There is also a risk of cardiotoxicity, requiring regular cardiac monitoring. Other potential side effects are headache, rash, and muscle pain.

What prior FDA approvals exist?

The FDA has approved several treatments for HER2-positive breast cancer, including monoclonal antibodies like trastuzumab and pertuzumab. Trastuzumab was one of the first targeted therapies approved for HER2-positive breast cancer, often used in combination with chemotherapy. Pertuzumab, another monoclonal antibody, is approved for use in combination with trastuzumab and chemotherapy, showing improved outcomes in patients. Additionally, T-DM1 (ado-trastuzumab emtansine) and T-DXd (fam-trastuzumab deruxtecan) are antibody-drug conjugates approved for patients who have progressed on prior HER2-targeted therapies. These treatments highlight the ongoing advancements in targeting the HER2 receptor to inhibit cancer cell growth and improve patient survival.

What other types of research exist?

Promising novel alternatives to the fixed-dose combination of pertuzumab and trastuzumab for HER2-positive breast cancer patients include Trastuzumab Deruxtecan (T-DXd) and the combination of Tucatinib, Capecitabine, and Trastuzumab. Trastuzumab Deruxtecan has shown efficacy in patients with previously treated HER2-positive breast cancer, including those with brain metastases. The Tucatinib, Capecitabine, and Trastuzumab regimen has demonstrated improved progression-free survival and overall survival in patients with HER2-positive metastatic breast cancer, particularly those with brain metastases.

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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

Must not have

Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis

History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-surgery (up to 27 weeks)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active liver disease such as hepatitis or autoimmune disorder.

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I have a history of irregular heartbeats or factors that increase my risk.

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I haven't had major surgery unrelated to breast cancer in the last 28 days and don't expect to need any during the study.

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All my breast cancer tumors are HER2 positive.

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My kidney function is reduced, with low creatinine clearance and high serum creatinine.

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I have had treatments or chest radiation for breast cancer before.

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I am on daily corticosteroid medication for a chronic condition.

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I had surgery to remove lymph nodes under my arm before starting treatment.

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I have cancer in both of my breasts.

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I do not have severe nerve damage in my hands or feet.

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My breast cancer has spread to other parts of my body.

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I currently have an infection that needs treatment.

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I had early breast cancer and received treatment for it.

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My bone marrow is not functioning properly.

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My liver isn't working properly.

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I have a serious heart condition or other major health issues.

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I have not received a live vaccine in the last 30 days and do not plan to during or shortly after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-surgery (up to 27 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-surgery (up to 27 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-surgery (up to 27 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants Achieving Pathologic Complete Response (pCR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Trastuzumab Emtansine

2016

Completed Phase 3

~5730

Investigator's Choice of Chemotherapy

2021

Completed Phase 2

~260

Radiotherapy

2017

Completed Phase 3

~2610

Surgery

2000

Completed Phase 3

~2490

Trastuzumab IV

2018

Completed Phase 3

~660

Pertuzumab IV

2018

Completed Phase 3

~660

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HER2-positive breast cancer include monoclonal antibodies like pertuzumab and trastuzumab, which target the HER2 receptor on cancer cells. By binding to this receptor, these antibodies inhibit the signaling pathways that promote cancer cell growth and survival. This targeted approach is crucial as it specifically attacks cancer cells while sparing normal cells, leading to fewer side effects compared to traditional chemotherapy. Other treatments include hormone therapy, which blocks hormones that fuel certain types of breast cancer, and chemotherapy, which kills rapidly dividing cells but can affect both cancerous and healthy cells. The combination of these therapies can improve treatment efficacy and patient outcomes.