What side effects are associated with this type of intervention?

Common treatments for HER2-positive breast cancer include chemotherapy and targeted therapies such as trastuzumab and pertuzumab. Chemotherapy side effects often include fatigue, nausea, hair loss, and increased risk of infection due to lowered white blood cell counts. Targeted therapies like trastuzumab and pertuzumab can cause side effects such as diarrhea, fatigue, and potential heart problems, including decreased heart function. Monitoring and managing these side effects are crucial for patient care.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve chemotherapy and imaging techniques. For instance, trastuzumab (Herceptin) is a monoclonal antibody used in HER2-positive breast cancer, often in combination with chemotherapy. Pertuzumab (Perjeta) is another HER2-targeted therapy used alongside trastuzumab and docetaxel. Additionally, the use of FDG-PET/CT imaging has been explored to predict responses to these chemotherapies, although the imaging technique itself is more commonly used for diagnostic purposes rather than as a direct treatment modality.

What other types of research exist?

Promising novel alternatives to FDG-PET/CT for breast cancer patients in 2024 may include PET/CT using different radiotracers such as 18F-fluoroestradiol (FES) for estrogen receptor imaging, and advanced MRI techniques like diffusion-weighted imaging (DWI) and dynamic contrast-enhanced MRI (DCE-MRI). These methods can provide more specific information about tumor biology and response to therapy.

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FDG-PET/CT Scan Prediction for Breast Cancer

Phase 2

Recruiting

Led By Heather Jacene

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria

Must not have

Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an imaging procedure in patients with a specific type of breast cancer. The test uses a small amount of radioactive sugar to highlight active cancer areas, helping doctors decide if more or less treatment is needed before surgery. This imaging procedure has been used successfully for diagnosis, initial staging, restaging, early treatment response assessment, evaluation of disease spread, and predicting outcomes in breast cancer.

Who is the study for?

This trial is for adults (18+) with HER2-positive stage IIa-IIIc breast cancer who haven't started treatment. They must be in good health overall, not pregnant or breastfeeding, and have no history of severe illnesses that could affect the study. People with HIV can join if they're on effective therapy.

What is being tested?

The DIRECT Trial is testing whether a special imaging procedure using FDG-PET/CT scans before surgery can predict how well patients respond to standard chemotherapy for HER2-positive breast cancer.

What are the potential side effects?

Potential side effects mainly relate to the FDG-PET/CT scan itself, which includes exposure to radiation and possible allergic reactions to the radioactive tracer used during the imaging process.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer was stage IIa to IIIc when diagnosed.

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I plan to start a standard treatment with pertuzumab or similar for my cancer.

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My cancer is not classified as T4d.

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My cancer involves lymph nodes (cN1-3) and is T2-4 in size.

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My breast cancer is HER2-positive, confirmed by specific guidelines.

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I am 18 years old or older.

Exclusion Criteria

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

Select...

I have not received any treatment for my current breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Negative predictive value of neoadjuvant interim (ni) fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) for pathologic complete response (pCR)

Secondary study objectives

Performance of niFDG-PET/CT as predictor of 3-year event-free survival

Positive predictive value of niFDG-PET/CT for pCR

Sensitivity of niFDG-PET/CT for pCR

+1 more

Other study objectives

Compare deltaSULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCIST (trademark) to standard PET analysis software

Negative predictive value of niFDG-PET/CT for pCR

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: Diagnostic (FDG-PET/CT scan)Experimental Treatment5 Interventions

Patients receive FDG IV, undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Chemotherapy

2003

Completed Phase 4

~3050

Computed Tomography

2017

Completed Phase 2

~2740

Surgical Procedure

2020

Completed Phase 2

~160

0 / 8Eligibility 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

Common treatments for HER2-positive breast cancer include HER2-targeted therapies such as trastuzumab and chemotherapy. Trastuzumab is a monoclonal antibody that binds to the HER2 receptor on cancer cells, inhibiting their growth and survival. Chemotherapy works by targeting rapidly dividing cells, including cancer cells, to prevent their proliferation. These treatments are crucial for breast cancer patients as they can significantly improve survival rates and reduce the risk of recurrence. The use of FDG-PET/CT imaging helps in predicting the response to these therapies, allowing for personalized treatment plans that can optimize outcomes and minimize unnecessary side effects.

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