Research & Clinical Trials

Clinical trials follow a plan known as a protocol.  The protocol is carefully designed to balance the potential benefits and risks to participants and answer specific research questions. A protocol describes the following:

• The goal of the study

• Who is eligible to take part in the trial
• Details about test, procedures, and treatments
• How long the trials are expected to last
• How many participants are looking to be enrolled in the trial

• Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Approaches may include medicines, vaccines, or lifestyle changes.
• Screening trials test new ways of detecting diseases or health conditions.
• Diagnostic trials study or compare tests or procedures for diagnosing a particular disease or condition.
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Behavioral trials evaluate or compare ways to promote behavioral changes designed to improve health.
• Quality of life trials (or supportive care trials) explores and measure ways to improve the comfort and quality of life of people with conditions or illnesses.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

• Phase I Trials– researchers test a new drug or treatment in a small group of people for the first time. These studies evaluate how a new drug should be given, how often it should be administered, and the most effective dose with the fewest and least serious side effects.
• Phase II Trials– these studies continue to test the safety of the drug and how well it works in a selected tumor type.
• Phase III Trials– these studies will confirm the new drug effectiveness, observe side effects, compare the new treatment with currently used standard treatments, and collect information that will allow the new drug to be used safely.
• Phase IV Trials– these studies test the drug or treatment after FDA approval to find out additional information about the treatment’s risks and benefits and the best way to use it. These studies help doctors understand the long-term safety.

Breast Cancer Screening Trial

Sponsor: ECOG-ACRIN

Study: EA1151

Summary: Randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

Inclusion Criteria:

• Ages Eligible for Study: 45 years to 74 years
• Sexes Eligible: Female
• Women of childbearing potential must not be known to be pregnant or lactating
• Patients must be scheduled for, or have intent to schedule, a screening mammogram
• Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
• Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
• Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
• Patients must not have breast enhancements (e.g., implants or injections)

To learn more about available clinical research trials contact:

Deborah Brunetti, RN, CRC
Hunterdon Regional Cancer Center – Research Department
2100 Wescott Drive, Flemington, NJ 08822
908-237-2330 option #3