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PET scans may guide breast cancer treatment before surgery

NCT ID NCT05710328

Diagnosis Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether a special PET/CT scan using a radioactive tracer (FDG) can predict how well HER2-positive breast cancer responds to standard chemotherapy before surgery. About 235 patients with stage II-III HER2+ breast cancer will get the scan early in treatment. The goal is to see if the scan can help doctors decide if a patient needs more or less chemo for the best outcome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fludeoxyglucose F-18 (FDG) radioactive tracer
What this could lead to
If successful, this imaging method could help doctors personalize chemotherapy for HER2+ breast cancer, potentially reducing unnecessary treatment or guiding more effective therapy before surgery.
What could go wrong
This is a phase 2 trial with 235 participants, so results are preliminary. The imaging prediction may not be accurate enough to change standard care, and false negatives could lead to undertreatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 235 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer HER2 positive breast carcinoma invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage II breast cancer ajcc V8 Anatomic stage III breast cancer ajcc V8 HER2-positive breast carcinoma Invasive breast carcinoma

Contacts and locations

Locations

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105, United States

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017, United States

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671, United States

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120, United States

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655, United States

  • Bryn Mawr Health Center

    Newtown Square, Pennsylvania, 19073, United States

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010, United States

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004, United States

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060, Puerto Rico

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Castle Medical Center

    Kailua, Hawaii, 96734, United States

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927, Puerto Rico

  • Chester County Hospital

    West Chester, Pennsylvania, 19380, United States

  • Community Medical Center

    Scranton, Pennsylvania, 18510, United States

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • CoxHealth South Hospital

    Springfield, Missouri, 65807, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701, United States

  • Doctors Cancer Center

    Manati, 00674, Puerto Rico

  • FHCC South Lake Union

    Seattle, Washington, 98109, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840, United States

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701, United States

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431, United States

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062, United States

  • Inspira Medical Center Vineland

    Vineland, New Jersey, 08360, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112, United States

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494, United States

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848, United States

  • Marshfield Medical Center - Neillsville

    Neillsville, Wisconsin, 54456, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, 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

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433, United States

  • Mercy Hospital South

    St Louis, Missouri, 63128, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337, United States

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109, United States

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301, United States

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416, United States

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813, United States

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Saint John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503, United States

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301, 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

  • San Juan City Hospital

    San Juan, 00936, Puerto Rico

  • San Juan Community Oncology Group

    San Juan, 00917, Puerto Rico

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • United Hospital

    Saint Paul, Minnesota, 55102, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas at Austin

    Austin, Texas, 78712, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.