Breast Cancer

EA1211 / DIRECT



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

STATUS: Active


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.
  • 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.

  • 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 receptorโ€“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 not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.

  • 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 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.

  • 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.

United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu

AZ
Phoenix
Cancer Center at Saint Joseph's
Contact: Site Public Contact
Email: Research-cancerinstitute@dignityhealth.org

CA
Santa Monica
Saint John's Cancer Institute
Contact: Site Public Contact

HI
Aiea
Hawaii Cancer Care - Westridge
Contact: Site Public Contact
Email: info@hawaiicancercare.com

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Kapiolani Medical Center for Women and Children
Contact: Site Public Contact

Queen's Cancer Cenrer - POB I
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Contact: Site Public Contact

Queen's Medical Center
Contact: Site Public Contact

University of Hawaii Cancer Center
Contact: Site Public Contact

Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Contact: Site Public Contact

ID
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Chicago
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu

Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com

Geneva
Northwestern Medicine Cancer Center Delnor
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Lake Forest
Northwestern Medicine Lake Forest Hospital
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com

Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

MA
Boston
Dana-Farber Cancer Institute
Contact: Site Public Contact

MI
Detroit
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

MN
Burnsville
Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Springfield
CoxHealth South Hospital
Contact: Site Public Contact

MS
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

NE
Bellevue
Nebraska Medicine-Bellevue
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Omaha
Nebraska Medicine-Village Pointe
Contact: Site Public Contact

University of Nebraska Medical Center
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

NJ
Morristown
Morristown Medical Center
Contact: Site Public Contact

Paterson
Saint Joseph's Regional Medical Center
Contact: Site Public Contact
Email: HallL@sjhmc.org

NY
Bronx
Montefiore Medical Center-Einstein Campus
Contact: Site Public Contact
Email: eskwak@montefiore.org

OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cleveland
MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

PA
Bryn Mawr
Bryn Mawr Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Media
Riddle Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

Newtown Square
Bryn Mawr Health Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org

West Chester
Chester County Hospital
Contact: Site Public Contact

Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org

PR
Bayamon
Cancer Center-Metro Medical Center Bayamon
Contact: Site Public Contact

Manati
Doctors Cancer Center
Contact: Site Public Contact

San Juan
Centro Comprensivo de Cancer de UPR
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

San Juan City Hospital
Contact: Site Public Contact

San Juan Community Oncology Group
Contact: Site Public Contact

TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org

UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Ladysmith
Marshfield Clinic - Ladysmith Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Neillsville
Marshfield Medical Center - Neillsville
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

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.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months thereafter for up to 5 years after date of registration.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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ECOG-ACRIN Cancer Research Group