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Monoclonal Antibodies

Pertuzumab + Trastuzumab for HER2-Positive Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if early changes seen on PET scans can predict which patients will respond best to a combination of two drugs before surgery.

Who is the study for?

This trial is for adults with untreated breast cancer that's not yet spread elsewhere (stages T2, T3, or T4a-c), who are willing to use non-hormonal contraception if they can have children. They must be able to undergo PET scans and biopsies, have a certain type of tumor (HER2-positive and low hormone receptor levels), and their body should be functioning well overall.

What is being tested?

The study tests whether early changes seen on PET scans can predict the success of pre-surgery treatment with trastuzumab and pertuzumab in patients with HER2-positive breast cancer. It aims to see if these imaging changes correlate with how well the tumors respond.

What are the potential side effects?

Trastuzumab and pertuzumab may cause heart problems, allergic reactions, infusion-related symptoms like chills or fever, fatigue, nausea, diarrhea, rash or muscle pain. The severity of side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)

Secondary study objectives

Change in PI3K Pathway Activation With Response

Change in ptDNA With Response

Changes in Ki67 With Response

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Trastuzumab and PertuzumabExperimental Treatment3 Interventions

Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron emission tomography (PET)

2008

Completed Phase 3

~70

Trastuzumab

2014

Completed Phase 4

~5190