ACTIVE_NOT_RECRUITING

Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial

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Conditions

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8HER2-Positive Breast CarcinomaInvasive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial

Quick Facts

Study Start:2023-05-10
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05710328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients (all genders) must be \>= 18 years of age.
  2. * 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.
  3. * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. * 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.
  5. * 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.
  6. * Patient must have American Joint Committee on Cancer (AJCC) 8th Edition stage IIa-IIIc according to anatomic staging table at diagnosis and below criteria.
  7. * Patients without nodal involvement (cN0) are eligible if T size \> 2.0 cm (T2-4)
  8. * Patients with nodal involvement (cN1-3) are eligible if T2-4
  9. * Patients with clinical T4d are not eligible
  10. * 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.
  11. * 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.
  12. * Patient must plan to start a standard neoadjuvant pertuzumab (or other biosimilars) based regimen.
  13. * 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.
  14. * 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.
  15. * 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.
  16. * 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.
  17. * Patients must not have used colony stimulating growth factors within 14 days prior to completing a T0 scan done prior to registration.
  1. * Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
  2. * 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.
  3. * 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.
  4. * Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values \> 200 mg/dL and severe claustrophobia.

Contacts and Locations

Principal Investigator

Heather Jacene
PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Saint John's Cancer Institute
Santa Monica, California, 90404
United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Castle Medical Center
Kailua, Hawaii, 96734
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
United States
Northwestern University
Chicago, Illinois, 60611
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Mercy Hospital South
St Louis, Missouri, 63128
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062
United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360
United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063
United States
Bryn Mawr Health Center
Newtown Square, Pennsylvania, 19073
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
United States
Community Medical Center
Scranton, Pennsylvania, 18510
United States
Chester County Hospital
West Chester, Pennsylvania, 19380
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
United States
University of Texas at Austin
Austin, Texas, 78712
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
FHCC South Lake Union
Seattle, Washington, 98109
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center - Neillsville
Neillsville, Wisconsin, 54456
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

  • Heather Jacene, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2023-05-10
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • HER2-Positive Breast Carcinoma
  • Invasive Breast Carcinoma