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Monoclonal Antibodies

PET Scan Predictors for HER2+ Breast Cancer Treatment Response

Phase 2

Waitlist Available

Led By Joanne Mortimer

Research Sponsored by City of Hope Medical Center

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 up to 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial studies if a scan can predict how well HER2+ breast cancer will respond to trastuzumab & pertuzumab before surgery.

Who is the study for?

This trial is for women with HER2 positive breast cancer that's locally advanced. They must have a tumor at least 2cm big or similarly sized lymph nodes, confirmed by imaging tests. Participants need normal heart function and haven't had prior HER2 treatments. Pregnant women can't join, nor those who've received treatment for the current cancer or have another active cancer.

What is being tested?

The study is testing if a PET scan using Cu64-DOTA-trastuzumab can predict how well patients respond to pre-surgery treatment with trastuzumab and pertuzumab. It involves diagnostic procedures before receiving six cycles of combined therapy with these drugs plus chemotherapy.

What are the potential side effects?

Potential side effects from trastuzumab and pertuzumab may include allergic reactions, heart problems, infusion-related symptoms like chills or fever, diarrhea, nausea, fatigue, rash, and possible low blood cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).

Other study objectives

SUV Measurement by 64Cu-DOTA Trastuzumab PET

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)Experimental Treatment6 Interventions

Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

FDA approved

Pertuzumab

FDA approved

Positron Emission Tomography

2011

Completed Phase 2

~2200