University of Alabama at Birmingham Cancer Center
Not reportedBirmingham, Alabama, 35233, United States
Contact details are not published in this record. Check official study record ↗
CLINICAL STUDY · NCT05710328
Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial
Active, not recruitingPhase 2Interventional
Sponsored by ECOG-ACRIN Cancer Research Group
- Condition
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Positive Breast Carcinoma, Invasive Breast Carcinoma
- Study locations
- 102 reported sites
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.
Full official title
Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial
Detailed description
PRIMARY OBJECTIVE:
I. To estimate the negative predictive value (NPV) of neoadjuvant interim (ni)FDG-PET/CT for pathologic complete response (pCR), using delta maximum standardized uptake value corrected for lean body mass day 15 (deltaSULmaxD15), completed through central review, of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
SECONDARY OBJECTIVES:
I. To estimate the sensitivity, specificity, and positive predictive value (PPV) of niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
II. To evaluate the performance of niFDG-PET/CT, using deltaSULmaxD15 of the primary breast cancer at a threshold of 40%, as a predictor of 3-year event-free survival (EFS) from time of study registration.
EXPLORATORY OBJECTIVES:
I. To estimate the NPV of niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary breast cancer at a grid of alternative thresholds ranging from 30% to 60%, in patients treated with neoadjuvant HER2-directed therapy.
II. To compare deltaSULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCIST (trademark) to standard PET analysis software.
OUTLINE:
Patients receive FDG intravenously (IV), undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study.
I. To estimate the negative predictive value (NPV) of neoadjuvant interim (ni)FDG-PET/CT for pathologic complete response (pCR), using delta maximum standardized uptake value corrected for lean body mass day 15 (deltaSULmaxD15), completed through central review, of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
SECONDARY OBJECTIVES:
I. To estimate the sensitivity, specificity, and positive predictive value (PPV) of niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary breast cancer at a threshold of 40%, in patients treated with neoadjuvant HER2-directed therapy.
II. To evaluate the performance of niFDG-PET/CT, using deltaSULmaxD15 of the primary breast cancer at a threshold of 40%, as a predictor of 3-year event-free survival (EFS) from time of study registration.
EXPLORATORY OBJECTIVES:
I. To estimate the NPV of niFDG-PET/CT for pCR, using deltaSULmaxD15 of the primary breast cancer at a grid of alternative thresholds ranging from 30% to 60%, in patients treated with neoadjuvant HER2-directed therapy.
II. To compare deltaSULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCIST (trademark) to standard PET analysis software.
OUTLINE:
Patients receive FDG intravenously (IV), undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study.
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion criteria
Inclusion Criteria:
* Patients (all genders) must be \>= 18 years of age.
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing.
* Patient must have known (either positive or negative) hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible.
* Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
* Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4)
* Patients with nodal involvement (cN1-3) are eligible if T2-4
* Patients with clinical T4d are not eligible
* Patients with bilateral invasive breast cancers are eligible if both cancers are HER2-positive and at least one meets all protocol eligibility criteria and neither cancer renders the patient ineligible.
* Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive and at least one tumor focus meets all eligibility criteria. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing.
* Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of this imaging intervention are eligible for this trial.
* Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
* Patient must be participating in the trial at an institution which has agreed to perform the imaging research studies, completed the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Center Group (ECOG-ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval.
* For patients who completed the baseline (T0) FDG-PET/CT PRIOR to registration, neoadjuvant pertuzumab-based regimen must start after study registration and within 21 days after the T0 scan.
* Patients must not have used colony stimulating growth factors within 14 days prior to completing a T0 scan done prior to registration.
Exclusion Criteria:
* Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the teratogenic effects of FDG in addition to the radiation exposure during PET/CT. All patients of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy.
* NOTE: A pregnancy test within 7 days prior to the T0 scan is also required but will only need to be done if a) the T0 scan is completed after study registration and b) if the pregnancy test done prior to registration is completed outside of the 7-day window.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values \> 200 mg/dL and severe claustrophobia.
* Patients (all genders) must be \>= 18 years of age.
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing.
* Patient must have known (either positive or negative) hormone receptor (estrogen receptor \[ER\] or progesterone receptor \[PR\]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible.
* Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
* Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4)
* Patients with nodal involvement (cN1-3) are eligible if T2-4
* Patients with clinical T4d are not eligible
* Patients with bilateral invasive breast cancers are eligible if both cancers are HER2-positive and at least one meets all protocol eligibility criteria and neither cancer renders the patient ineligible.
* Patients with multiple ipsilateral invasive tumors are eligible as long as all tumors are HER2-positive and at least one tumor focus meets all eligibility criteria. Multiple lesions that appear part of the same index tumor do not require additional biopsy/HER2 testing.
* Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of this imaging intervention are eligible for this trial.
* Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
* Patient must be participating in the trial at an institution which has agreed to perform the imaging research studies, completed the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Center Group (ECOG-ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval.
* For patients who completed the baseline (T0) FDG-PET/CT PRIOR to registration, neoadjuvant pertuzumab-based regimen must start after study registration and within 21 days after the T0 scan.
* Patients must not have used colony stimulating growth factors within 14 days prior to completing a T0 scan done prior to registration.
Exclusion Criteria:
* Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the teratogenic effects of FDG in addition to the radiation exposure during PET/CT. All patients of childbearing potential must have a blood test or urine study within 7 days prior to registration to rule out pregnancy.
* NOTE: A pregnancy test within 7 days prior to the T0 scan is also required but will only need to be done if a) the T0 scan is completed after study registration and b) if the pregnancy test done prior to registration is completed outside of the 7-day window.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values \> 200 mg/dL and severe claustrophobia.
NEAR YOU
Study locations worldwide
102 sitesCheck the individual site’s status and contact the listed study team for current availability.
102 sites shown
Cancer Center at Saint Joseph's
Not reportedPhoenix, Arizona, 85004, United States
Contact details are not published in this record. Check official study record ↗
Los Angeles General Medical Center
Not reportedLos Angeles, California, 90033, United States
Contact details are not published in this record. Check official study record ↗
USC / Norris Comprehensive Cancer Center
Not reportedLos Angeles, California, 90033, United States
Contact details are not published in this record. Check official study record ↗
Saint John's Cancer Institute
Not reportedSanta Monica, California, 90404, United States
Contact details are not published in this record. Check official study record ↗
Sibley Memorial Hospital
Not reportedWashington D.C., District of Columbia, 20016, United States
Contact details are not published in this record. Check official study record ↗
Mayo Clinic in Florida
Not reportedJacksonville, Florida, 32224-9980, United States
Contact details are not published in this record. Check official study record ↗
Hawaii Cancer Care Inc - Waterfront Plaza
Not reportedHonolulu, Hawaii, 96813, United States
Contact details are not published in this record. Check official study record ↗
Queen's Cancer Cenrer - POB I
Not reportedHonolulu, Hawaii, 96813, United States
Contact details are not published in this record. Check official study record ↗
Queen's Medical Center
Not reportedHonolulu, Hawaii, 96813, United States
Contact details are not published in this record. Check official study record ↗
University of Hawaii Cancer Center
Not reportedHonolulu, Hawaii, 96813, United States
Contact details are not published in this record. Check official study record ↗
Queen's Cancer Center - Kuakini
Not reportedHonolulu, Hawaii, 96817, United States
Contact details are not published in this record. Check official study record ↗
Kapiolani Medical Center for Women and Children
Not reportedHonolulu, Hawaii, 96826, United States
Contact details are not published in this record. Check official study record ↗
Castle Medical Center
Not reportedKailua, Hawaii, 96734, United States
Contact details are not published in this record. Check official study record ↗
Wilcox Memorial Hospital and Kauai Medical Clinic
Not reportedLihue, Hawaii, 96766, United States
Contact details are not published in this record. Check official study record ↗
Hawaii Cancer Care - Westridge
Not reported‘Aiea, Hawaii, 96701, United States
Contact details are not published in this record. Check official study record ↗
Saint Luke's Cancer Institute - Twin Falls
Not reportedTwin Falls, Idaho, 83301, United States
Contact details are not published in this record. Check official study record ↗
Northwestern University
Not reportedChicago, Illinois, 60611, United States
Contact details are not published in this record. Check official study record ↗
Carle at The Riverfront
Not reportedDanville, Illinois, 61832, United States
Contact details are not published in this record. Check official study record ↗
Northwestern Medicine Cancer Center Kishwaukee
Not reportedDeKalb, Illinois, 60115, United States
Contact details are not published in this record. Check official study record ↗
Carle Physician Group-Effingham
Not reportedEffingham, Illinois, 62401, United States
Contact details are not published in this record. Check official study record ↗
Northwestern Medicine Cancer Center Delnor
Not reportedGeneva, Illinois, 60134, United States
Contact details are not published in this record. Check official study record ↗
Northwestern Medicine Lake Forest Hospital
Not reportedLake Forest, Illinois, 60045, United States
Contact details are not published in this record. Check official study record ↗
Carle Physician Group-Mattoon/Charleston
Not reportedMattoon, Illinois, 61938, United States
Contact details are not published in this record. Check official study record ↗
Carle Cancer Center
Not reportedUrbana, Illinois, 61801, United States
Contact details are not published in this record. Check official study record ↗
Northwestern Medicine Cancer Center Warrenville
Not reportedWarrenville, Illinois, 60555, United States
Contact details are not published in this record. Check official study record ↗
The James Graham Brown Cancer Center at University of Louisville
Not reportedLouisville, Kentucky, 40202, United States
Contact details are not published in this record. Check official study record ↗
Louisiana State University Health Science Center
Not reportedNew Orleans, Louisiana, 70112, United States
Contact details are not published in this record. Check official study record ↗
University Medical Center New Orleans
Not reportedNew Orleans, Louisiana, 70112, United States
Contact details are not published in this record. Check official study record ↗
Johns Hopkins University/Sidney Kimmel Cancer Center
Not reportedBaltimore, Maryland, 21287, United States
Contact details are not published in this record. Check official study record ↗
Dana-Farber Cancer Institute
Not reportedBoston, Massachusetts, 02215, United States
Contact details are not published in this record. Check official study record ↗
Wayne State University/Karmanos Cancer Institute
Not reportedDetroit, Michigan, 48201, United States
Contact details are not published in this record. Check official study record ↗
Minnesota Oncology - Burnsville
Not reportedBurnsville, Minnesota, 55337, United States
Contact details are not published in this record. Check official study record ↗
Mercy Hospital
Not reportedCoon Rapids, Minnesota, 55433, United States
Contact details are not published in this record. Check official study record ↗
Minnesota Oncology Hematology PA-Maplewood
Not reportedMaplewood, Minnesota, 55109, United States
Contact details are not published in this record. Check official study record ↗
Abbott-Northwestern Hospital
Not reportedMinneapolis, Minnesota, 55407, United States
Contact details are not published in this record. Check official study record ↗
Mayo Clinic in Rochester
Not reportedRochester, Minnesota, 55905, United States
Contact details are not published in this record. Check official study record ↗
Park Nicollet Clinic - Saint Louis Park
Not reportedSaint Louis Park, Minnesota, 55416, United States
Contact details are not published in this record. Check official study record ↗
United Hospital
Not reportedSaint Paul, Minnesota, 55102, United States
Contact details are not published in this record. Check official study record ↗
Minnesota Oncology Hematology PA-Woodbury
Not reportedWoodbury, Minnesota, 55125, United States
Contact details are not published in this record. Check official study record ↗
Baptist Memorial Hospital and Cancer Center-Oxford
Not reportedOxford, Mississippi, 38655, United States
Contact details are not published in this record. Check official study record ↗
Baptist Memorial Hospital and Cancer Center-Desoto
Not reportedSouthhaven, Mississippi, 38671, United States
Contact details are not published in this record. Check official study record ↗
CoxHealth South Hospital
Not reportedSpringfield, Missouri, 65807, United States
Contact details are not published in this record. Check official study record ↗
Mercy Hospital South
Not reportedSt Louis, Missouri, 63128, United States
Contact details are not published in this record. Check official study record ↗
Nebraska Medicine-Bellevue
Not reportedBellevue, Nebraska, 68123, United States
Contact details are not published in this record. Check official study record ↗
Nebraska Medicine-Village Pointe
Not reportedOmaha, Nebraska, 68118, United States
Contact details are not published in this record. Check official study record ↗
University of Nebraska Medical Center
Not reportedOmaha, Nebraska, 68198, United States
Contact details are not published in this record. Check official study record ↗
Cooper Hospital University Medical Center
Not reportedCamden, New Jersey, 08103, United States
Contact details are not published in this record. Check official study record ↗
Morristown Medical Center
Not reportedMorristown, New Jersey, 07960, United States
Contact details are not published in this record. Check official study record ↗
Inspira Medical Center Mullica Hill
Not reportedMullica Hill, New Jersey, 08062, United States
Contact details are not published in this record. Check official study record ↗
Saint Joseph's Regional Medical Center
Not reportedPaterson, New Jersey, 07503, United States
Contact details are not published in this record. Check official study record ↗
Inspira Medical Center Vineland
Not reportedVineland, New Jersey, 08360, United States
Contact details are not published in this record. Check official study record ↗
MD Anderson Cancer Center at Cooper-Voorhees
Not reportedVoorhees Township, New Jersey, 08043, United States
Contact details are not published in this record. Check official study record ↗
Roswell Park Cancer Institute
Not reportedBuffalo, New York, 14263, United States
Contact details are not published in this record. Check official study record ↗
Montefiore Medical Center-Einstein Campus
Not reportedThe Bronx, New York, 10461, United States
Contact details are not published in this record. Check official study record ↗
UNC Lineberger Comprehensive Cancer Center
Not reportedChapel Hill, North Carolina, 27599, United States
Contact details are not published in this record. Check official study record ↗
Indu and Raj Soin Medical Center
Not reportedBeavercreek, Ohio, 45431, United States
Contact details are not published in this record. Check official study record ↗
MetroHealth Medical Center
Not reportedCleveland, Ohio, 44109, United States
Contact details are not published in this record. Check official study record ↗
Ohio State University Comprehensive Cancer Center
Not reportedColumbus, Ohio, 43210, United States
Contact details are not published in this record. Check official study record ↗
Kettering Medical Center
Not reportedKettering, Ohio, 45429, United States
Contact details are not published in this record. Check official study record ↗
University of Oklahoma Health Sciences Center
Not reportedOklahoma City, Oklahoma, 73104, United States
Contact details are not published in this record. Check official study record ↗
Bryn Mawr Hospital
Not reportedBryn Mawr, Pennsylvania, 19010, United States
Contact details are not published in this record. Check official study record ↗
Geisinger Medical Center
Not reportedDanville, Pennsylvania, 17822, United States
Contact details are not published in this record. Check official study record ↗
Riddle Memorial Hospital
Not reportedMedia, Pennsylvania, 19063, United States
Contact details are not published in this record. Check official study record ↗
Bryn Mawr Health Center
Not reportedNewtown Square, Pennsylvania, 19073, United States
Contact details are not published in this record. Check official study record ↗
Paoli Memorial Hospital
Not reportedPaoli, Pennsylvania, 19301, United States
Contact details are not published in this record. Check official study record ↗
Guthrie Medical Group PC-Robert Packer Hospital
Not reportedSayre, Pennsylvania, 18840, United States
Contact details are not published in this record. Check official study record ↗
Community Medical Center
Not reportedScranton, Pennsylvania, 18510, United States
Contact details are not published in this record. Check official study record ↗
Chester County Hospital
Not reportedWest Chester, Pennsylvania, 19380, United States
Contact details are not published in this record. Check official study record ↗
Geisinger Wyoming Valley/Henry Cancer Center
Not reportedWilkes-Barre, Pennsylvania, 18711, United States
Contact details are not published in this record. Check official study record ↗
Lankenau Medical Center
Not reportedWynnewood, Pennsylvania, 19096, United States
Contact details are not published in this record. Check official study record ↗
Baptist Memorial Hospital and Cancer Center-Collierville
Not reportedCollierville, Tennessee, 38017, United States
Contact details are not published in this record. Check official study record ↗
Baptist Memorial Hospital and Cancer Center-Memphis
Not reportedMemphis, Tennessee, 38120, United States
Contact details are not published in this record. Check official study record ↗
Dell Seton Medical Center at The University of Texas
Not reportedAustin, Texas, 78701, United States
Contact details are not published in this record. Check official study record ↗
University of Texas at Austin
Not reportedAustin, Texas, 78712, United States
Contact details are not published in this record. Check official study record ↗
Huntsman Cancer Institute/University of Utah
Not reportedSalt Lake City, Utah, 84112, United States
Contact details are not published in this record. Check official study record ↗
Virginia Commonwealth University/Massey Cancer Center
Not reportedRichmond, Virginia, 23298, United States
Contact details are not published in this record. Check official study record ↗
FHCC South Lake Union
Not reportedSeattle, Washington, 98109, United States
Contact details are not published in this record. Check official study record ↗
Fred Hutchinson Cancer Center
Not reportedSeattle, Washington, 98109, United States
Contact details are not published in this record. Check official study record ↗
University of Washington Medical Center - Montlake
Not reportedSeattle, Washington, 98195, United States
Contact details are not published in this record. Check official study record ↗
Aurora Cancer Care-Southern Lakes VLCC
Not reportedBurlington, Wisconsin, 53105, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center-EC Cancer Center
Not reportedEau Claire, Wisconsin, 54701, United States
Contact details are not published in this record. Check official study record ↗
Aurora Health Care Germantown Health Center
Not reportedGermantown, Wisconsin, 53022, United States
Contact details are not published in this record. Check official study record ↗
Saint Vincent Hospital Cancer Center Green Bay
Not reportedGreen Bay, Wisconsin, 54301, United States
Contact details are not published in this record. Check official study record ↗
Saint Vincent Hospital Cancer Center at Saint Mary's
Not reportedGreen Bay, Wisconsin, 54303, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center - Ladysmith
Not reportedLadysmith, Wisconsin, 54848, United States
Contact details are not published in this record. Check official study record ↗
University of Wisconsin Carbone Cancer Center - University Hospital
Not reportedMadison, Wisconsin, 53792, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center-Marshfield
Not reportedMarshfield, Wisconsin, 54449, United States
Contact details are not published in this record. Check official study record ↗
Aurora Saint Luke's Medical Center
Not reportedMilwaukee, Wisconsin, 53215, United States
Contact details are not published in this record. Check official study record ↗
Aurora Sinai Medical Center
Not reportedMilwaukee, Wisconsin, 53233, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Clinic-Minocqua Center
Not reportedMinocqua, Wisconsin, 54548, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center - Neillsville
Not reportedNeillsville, Wisconsin, 54456, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center-Rice Lake
Not reportedRice Lake, Wisconsin, 54868, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center-River Region at Stevens Point
Not reportedStevens Point, Wisconsin, 54482, United States
Contact details are not published in this record. Check official study record ↗
Aurora West Allis Medical Center
Not reportedWest Allis, Wisconsin, 53227, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Medical Center - Weston
Not reportedWeston, Wisconsin, 54476, United States
Contact details are not published in this record. Check official study record ↗
Marshfield Clinic - Wisconsin Rapids Center
Not reportedWisconsin Rapids, Wisconsin, 54494, United States
Contact details are not published in this record. Check official study record ↗
Cancer Center-Metro Medical Center Bayamon
Not reportedBayamón, 00959-5060, Puerto Rico
Contact details are not published in this record. Check official study record ↗
Doctors Cancer Center
Not reportedManati, 00674, Puerto Rico
Contact details are not published in this record. Check official study record ↗
San Juan Community Oncology Group
Not reportedSan Juan, 00917, Puerto Rico
Contact details are not published in this record. Check official study record ↗
Centro Comprensivo de Cancer de UPR
Not reportedSan Juan, 00927, Puerto Rico
Contact details are not published in this record. Check official study record ↗
San Juan City Hospital
Not reportedSan Juan, 00936, Puerto Rico
Contact details are not published in this record. Check official study record ↗
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
Interventions
Chemotherapy
Receive standard of care chemotherapy
Study groups: Diagnostic (FDG-PET/CT scan)
Other names: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Computed Tomography
Undergo PET/CT
Study groups: Diagnostic (FDG-PET/CT scan)
Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Fludeoxyglucose F-18
Given IV
Study groups: Diagnostic (FDG-PET/CT scan)
Other names: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Positron Emission Tomography
Undergo PET/CT
Study groups: Diagnostic (FDG-PET/CT scan)
Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Surgical Procedure
Undergo standard of care surgery
Study groups: Diagnostic (FDG-PET/CT scan)
Other names: Operation, Surgery, Surgery Type, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Study groups
Diagnostic (FDG-PET/CT scan)
Patients receive FDG IV, undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study.
Interventions: Drug: Chemotherapy, Procedure: Computed Tomography, Other: Fludeoxyglucose F-18, Procedure: Positron Emission Tomography, Procedure: Surgical Procedure
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnostic
- Allocation
- Not applicable
- Study model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 10 May 2023 · Actual
- Primary completion
- 31 May 2027 · Estimated
- Study completion
- 31 Dec 2029 · Estimated
- First registered
- 2 Feb 2023 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (1)
Negative predictive value of neoadjuvant interim (ni) fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) for pathologic complete response (pCR)
The analysis set for this objective will comprise all patients who enrolled in the study and had a FDG-PET/CT scan at T0 and T1 timepoint. The negative predictive value is defined as the probability that pCR will not be achieved by study participants who experience a using delta maximum standardized uptake value corrected for lean body mass day 15 (deltaSULmaxD15) below 40% and will be estimated via an exact, two-sided 95% confidence interval.
Time frame: Up to 5 years
Secondary outcomes (4)
Sensitivity of niFDG-PET/CT for pCR
The analysis set for this objective will be the same as for the primary objective. The estimation approach will also be similar.
Time frame: Up to 5 years
Specificity of niFDG-PET/CT for pCR
The analysis set for this objective will be the same as for the primary objective. The estimation approach will also be similar.
Time frame: Up to 5 years
Positive predictive value of niFDG-PET/CT for pCR
The analysis set for this objective will be the same as for the primary objective. The estimation approach will also be similar.
Time frame: Up to 5 years
Performance of niFDG-PET/CT as predictor of 3-year event-free survival
Using deltaSULmaxD15 of the primary breast cancer at a threshold of 40%. The analysis set for this objective will be the same as for the primary objective. The analysis will compare estimates of 3-year event-free survival between participants with deltaSULmaxD15 above and below the 40% threshold using a log-rank test.
Time frame: Up to 5 years
Other outcomes (2)
Negative predictive value of niFDG-PET/CT for pCR
The analytic approach for this objective will parallel the approach for the primary aim for each of selected thresholds in the range from 30% to 60%.
Time frame: Up to 5 years
Compare deltaSULmaxD15 using automated image analysis of FDG-PET/CT by AutoPERCIST (trademark) to standard PET analysis software
The analytic approach for this aim will include an assessment of agreement between measures of deltaSULmaxD15 obtained from two methods and an assessment of the negative and positive predictive value of the deltaSULmaxD15 measurement by AutoPERCIST (trademark).
Time frame: Up to 5 years
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Network
- Collaborators
- Not reported
- Organisation study ID
- EA1211
Central study contacts
No central contact is currently reported. Check the site contacts or the official record.
Study officials
Heather JacenePrincipal investigator · ECOG-ACRIN Cancer Research Group
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.
Publications (1)
- Hennessy MA, Gatsonis C, Jacene H, Connolly RM, Burnette BL, Stringer-Reasor EM, Romanoff J, Taurone A, O'Sullivan CC, Le-Petross HT, Stearns V, Fowler AM, Tang SC, Sepulveda KA, DeMichele AM, Mankoff DA, Wolff AC. EA1211: interim FDG-PET/CT for predicting response of HER2-positive breast cancer to neoadjuvant therapy (DIRECT trial). Future Oncol. 2025 Nov;21(26):3377-3384. doi: 10.1080/14796694.2025.2567840. Epub 2025 Oct 5. PubMed ↗