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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if a scan using a radioactive tracer & imaging can help doctors predict how well standard chemotherapy will work in HER2+ breast cancer patients.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Negative predictive value of neoadjuvant interim (ni) fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) for pathologic complete response (pCR)
Secondary outcome measures
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 moreOther outcome measures
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
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
2008
Completed Phase 2
~2240
Chemotherapy
2003
Completed Phase 4
~3050
Computed Tomography
2017
Completed Phase 2
~2720
Surgical Procedure
2020
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,687 Total Patients Enrolled
4 Trials studying Breast Cancer
3,528 Patients Enrolled for Breast Cancer
Heather JacenePrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer, but it won't affect this trial's treatment.I will start my pertuzumab-based treatment within 21 days after my initial scan and after registering for the study.My breast cancer's hormone receptor status is known, and it may be positive or negative.Both of my breast cancers are HER2 positive and at least one meets the trial's criteria.I have HIV, am on effective treatment, and my viral load is undetectable.My cancer has not spread to my lymph nodes and the tumor is larger than 2.0 cm.You cannot have a medical condition that would prevent you from having a PET/CT scan, such as high blood sugar levels or severe claustrophobia.I can take care of myself and am up and about more than half of my waking hours.My cancer was stage IIa to IIIc when diagnosed.I plan to start a standard treatment with pertuzumab or similar for my cancer.I haven't used any growth factor medications in the last 14 days.My cancer is not classified as T4d.I can understand and agree to the study's consent form, or I have someone who can legally do this for me.My cancer involves lymph nodes (cN1-3) and is T2-4 in size.All my breast cancer tumors are HER2 positive and at least one meets the trial's criteria.My breast cancer is HER2-positive, confirmed by specific guidelines.I am capable of becoming pregnant.I have not received any treatment for my current breast cancer.I am 18 years old or older.I am not pregnant or breastfeeding and have taken a pregnancy test within the last 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (FDG-PET/CT scan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks and complications arise from FDG-PET/CT scanning procedures?
"The safety of Diagnostic (FDG-PET/CT scan) was given a rating of 2 due to the limited evidence regarding its efficacy. Nonetheless, there is some data attesting to its security from Phase 2 studies."
Answered by AI
Is the research project currently open to more participants?
"Per the information listed on clinicaltrials.gov, this study is presently in its recruitment phase. It was initially reported on May 10th 2023 and modified for a final time on May 15th of the same year."
Answered by AI
How many participants have enlisted in this research study?
"Affirmative. Per the information located on clinicaltrials.gov, this medical trial is currently seeking participants and was first posted on May 10th 2023. The study will need to enroll 235 people across 1 site with the last update being made on May 15th 2023."
Answered by AI
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