Clinical trial recruitment and retention remain challenges in the quest to bring innovative therapies to all patients in need. In oncology, therapies continue to evolve, yet researchers are frequently faced with low trial participation, particularly among minority groups.
Oncology Practice Management (OPM) is dedicated to providing comprehensive information aimed at eliminating health disparities and improving access to therapies for people from all populations, including racial and ethnic minorities, people with limited access to healthcare due to lack of financial resources, and people living in rural communities.
While there are likely many reasons to explain why there are so few clinical trial participants, the key to addressing the issue comes down, to 3 main areas, according to Sam Abdelghany, PharmD, MMHA, BCOP, who is executive director of oncology pharmacy at Smilow Cancer Hospital at Yale New Haven Health. Abdelghany told a panel discussion at NCODA’s 6th Annual Oncology Institute meeting earlier this year, those 3 areas are: “why should I participate in this trial,” “can I do it,” and “who is asking me to join this trial?”
He said that addressing these questions early on, even introducing the topic of clinical trial participation at the initial diagnosis discussion, can and will likely go a long way to encourage participation, adding that the “who is asking” is a key part of the equation.
“Is the person asking a physician I can trust, is it someone who is looking out for my best interest, is the information translated it to me in a language I understand…these are all areas that need some work,” he said.
This monthly feature in OPM examines some of the cutting-edge trials that have been launched throughout 2024 and that are actively recruiting in breast cancer to help healthcare providers have these discussions with their patients. As the National Comprehensive Cancer Network has stated, “The best management of any cancer patient is in a clinical trial.”
These clinical trial listings can be found at www.ClinicalTrials.gov.
Comparison of the Breast Tumor Microenvironment
ClinicalTrials.gov identifier: NCT03165487
Sponsor: Columbia University
Conditions: Hormone receptor (HR)-positive malignant neoplasm of breast, triple-negative breast cancer
Location: New York, New York
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells-Positive Metastatic Breast Cancer
ClinicalTrials.gov identifier: NCT03213041
Sponsor: Northwestern University
Conditions: HER2-negative, estrogen receptor (ER)-positive, ER-negative, progesterone receptor (PR)-negative, recurrent breast carcinoma, stage IV breast cancer, triple-negative breast carcinoma
Locations: Chicago, Illinois
Surgical Excision vs Neoadjuvant Radiotherapy + Delayed Surgical Excision of Ductal Carcinoma (NORDIS)
ClinicalTrials.gov identifier: NCT03909282
Sponsor: Stanford University
Conditions: Ductal breast cancer in situ
Location: Stanford, California
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
ClinicalTrials.gov identifier: NCT04273555
Sponsor: University of Alabama at Birmingham
Conditions: HER2-positive breast cancer
Location: Birmingham, Alabama
Study of Screening Brain MRIs in Stage IV Breast Cancer
ClinicalTrials.gov identifier: NCT05115474
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Conditions: Triple-negative breast cancer, HER2-positive; HR-positive breast cancer
Locations: Clearwater, Florida; Tampa, Florida
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients with Advanced Breast Cancer
ClinicalTrials.gov identifier: NCT05216432
Sponsor: Relay Therapeutics, Inc.
Conditions: PIK3CA mutation, solid tumor, adult, HER2-negative, breast cancer, metastatic breast cancer, advanced breast cancer, unresectable solid tumor
Locations: Tucson, Arizona; San Diego, California; Denver, Colorado; Orlando, Florida; Plantation, Florida; Chicago, Illinois; Indianapolis, Indiana; Boston, Massachusetts; Ann Arbor, Michigan; Saint Louis, Missouri; New Brunswick, New Jersey; New York, New York; Nashville, Tennessee; Dallas, Texas; Houston, Texas; Fairfax, Virginia; Madison, Wisconsin; and locations throughout the world, including Australia, France, Italy, and Spain
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer (Breast53)
ClinicalTrials.gov identifier: NCT05288777
Sponsor: University of Virginia
Conditions: Breast cancer stages I, II, III
Location: Charlottesville, Virginia
Study of HER2-Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
ClinicalTrials.gov identifier: NCT05325632
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Conditions: HER2-positive breast cancer
Location: Tampa, Florida
VS-6766+Abema+Fulv in Met HR+/HER- BC
ClinicalTrials.gov identifier: NCT05608252
Sponsor: Dana-Farber Cancer Institute
Conditions: HR-positive breast cancer, HR-positive, HER2-negative breast cancer, breast cancer
Location: Boston, Massachusetts
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
ClinicalTrials.gov identifier: NCT05654532
Sponsor: Accutar Biotechnology, Inc.
Conditions: Breast cancer
Locations: Sarasota, Florida; Nashville, Tennessee; Houston, Texas; Norfolk, Virginia; Vancouver, Washington
A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
ClinicalTrials.gov identifier: NCT06127979
Sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Breast cancer
Locations: New York, New York
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
ClinicalTrials.gov identifier: NCT06188559
Sponsor: Eisai Inc.
Conditions: Breast cancer
Locations: Lost Alamitos, California; San Francisco, California; Tampa, Florida; Fort Wayne, Indiana; Des Moines, Iowa; Saint Louis, Missouri; Lincoln, Nebraska; Omaha, Nebraska; East Brunswick, New Jersey; Florham Park, New Jersey; New Brunswick, New Jersey; Albuquerque, New Mexico; Cleveland, Ohio; Salem, Oregon; Sioux Falls, South Dakota; Germantown, Tennessee; Puyallup, Washington; and locations throughout Japan
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
ClinicalTrials.gov identifier: NCT06106477
Sponsor: Medical College of Wisconsin
Conditions: Breast cancer
Location: Milwaukee, Wisconsin
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced And/or Metastatic Breast Cancer
ClinicalTrials.gov identifier: NCT06515470
Sponsor: Medical College of Wisconsin
Conditions: Breast cancer
Location: Milwaukee, Wisconsin
Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2+ Breast Cancer
ClinicalTrials.gov identifier: NCT05319873
Sponsor: Jonsson Comprehensive Cancer Center
Conditions: Anatomic stage IIA breast cancer AJCC; anatomic stage IIB breast cancer AJCC; anatomic stage III breast cancer AJCC; anatomic stage IIIA breast cancer AJCC; anatomic stage IIIB breast cancer AJCC, anatomic stage IIIC breast cancer AJCC; anatomic Stage IV Breast Cancer AJCC; invasive breast carcinoma; locally advanced HER2+ breast carcinoma; metastatic HER2+ breast carcinoma; prognostic Stage IB Breast Cancer AJCC; prognostic stage II breast Cancer AJCC; prognostic stage IIA breast cancer AJCC; prognostic Stage IIB Breast Cancer AJCC; prognostic stage III breast cancer AJCC; prognostic Stage IIIA breast cancer AJCC; prognostic Stage IIIB breast cancer AJCC; prognostic Stage IIIC Breast Cancer AJCC; prognostic Stage IV Breast Cancer AJCC
Location: Los Angeles, California
