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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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Other outcome measures

SUV Measurement by 64Cu-DOTA Trastuzumab PET

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

2008

Completed Phase 2

~2240

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,442 Total Patients Enrolled

43 Trials studying Breast Cancer

6,649 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,471 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Joanne MortimerPrincipal InvestigatorCity of Hope Medical Center

6 Previous Clinical Trials

157 Total Patients Enrolled

1 Trials studying Breast Cancer

18 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: Treatment (trastuzumab, copper Cu 64-DOTA-trastuzumab PET)

Breast Cancer Clinical Trial 2023: Pertuzumab Highlights & Side Effects. Trial Name: NCT02827877 — Phase 2

Pertuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02827877 — Phase 2

Frequently Asked Questions

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

Are there any available enrollment spots in this clinical trial?

"Clinicaltrials.gov data reveals that, although this medical study was initially posted on July 15th 2016 and last updated February 13th 2023, it is not currently enrolling participants. Fortunately, there are 2483 other clinical trials actively seeking candidates at the moment."

Answered by AI

Is there any existing research into the effects of Copper Cu 64-DOTA-Trastuzumab?

"Currently, 190 separate trials are being conducted with the drug Copper Cu 64-DOTA-Trastuzumab in Phase 3 of development. While many studies originate from Phoenix, Arizona, there exist 1587 different sites for this medication's clinical trial across the world."

Answered by AI

What medical condition is Copper Cu 64-DOTA-Trastuzumab usually prescribed for?

"Copper Cu 64-DOTA-Trastuzumab is a widely employed therapeutic for breast cancer. Additionally, it has been used to address issues such as the high risk of recurrence, initial line treatments and operative surgery."

Answered by AI

Has Copper Cu 64-DOTA-Trastuzumab received the necessary regulatory approvals to be used on patients?

"Our team has rated Copper Cu 64-DOTA-Trastuzumab a 2 for safety due to the presence of preclinical data suggesting its security, though there is no evidence that it's effective."

Answered by AI

How many individuals are being included in this research study?

"At this point in time, recruitment has ceased for the clinical trial. It was initially posted on 15th July 2016 and last updated 13th February 2023. If you are looking to join other studies, 2293 trials that target Her2 positive breast cancer patients as well as 190 Copper Cu 64-DOTA-Trastuzumab related trials remain open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer

2016. "Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02827877.