What is Targit Trial?

The Targit Trial is an international randomized controlled clinical trial comparing Single-Day Targeted Intraoperative Radiotherapy to Conventional Postoperative Radiotherapy for women with early stage invasive breast cancer treatable with lumpectomy. Currently, Single-Day Targeted Intraoperative Radiotherapy is investigational, which means that this treatment is still under evaluation as a treatment for breast cancer. Although small studies indicate that Single-Day Targeted Intraoperative Radiotherapy is as safe and effective as Conventional Postoperative Radiotherapy for certain patients, a long-term, scientific, head-to-head comparison of the two treatments is needed to determine if they are truly equal. This is the purpose of the Targit Trial.

The Targit Trial will determine if Single-Day Targeted Intraoperative Radiotherapy is as effective as 6-7 week Conventional Postoperative Radiotherapy for the treatment of early stage invasive breast cancer. This international study will enroll 2,400 women age 40 and older with invasive breast cancers measuring 3cm (1-1/8 inches) or less.

In the Targit Trial, half of the participants will receive Single-Day Targeted Intraoperative Radiotherapy given at the time of surgery. The other half will receive Conventional Postoperative Radiotherapy given over a 6-7 week period beginning after surgery. The goal of the Targit Trial is to determine if the two treatments are equal in terms of breast cancer recurrence, overall survival, cosmetic outcome, and patient satisfaction.

What is a randomized controlled trial?

A randomized controlled trial is a scientific study in which different treatments are compared in an organized and objective manner. Randomized means that a computer will assign one of the two treatments to each patient in a process similar to tossing a coin. Controlled means that the study is being performed under well-defined conditions that are established before the study is started. The goal of a randomized controlled trial is to eliminate bias so that the results of the study will be truly believable.

A randomized controlled trial is the best way to determine the safety and effectiveness of different treatments. In fact, it is because of randomized controlled trials that most women today can safely receive breast conservation therapy (lumpectomy + radiotherapy) instead of mastectomy, without fear of reducing the chances of surviving breast cancer. Prior to these trials, mastectomy was the only treatment offered to women with breast cancer.

How can I participate in the Targit Trial?

There are 4 steps to determining who receives Single-Day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy.

1. Determination of Eligibility: Prior to joining the study, you must meet with the study investigators at USC to determine if you qualify for the Targit trial. This evaluation will include a physical examination, review of your mammograms and ultrasounds, and review of your pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining your eligibility for the study.

In order to participate in the Targit Trial, the following criteria must be met:
· You must be age 40 or older
· You must have invasive (also called infiltrating) breast cancer
· You must have a breast cancer measuring 3 centimeters (1-1/8 inches) or less
· You must have a breast cancer treatable with lumpectomy
· You must be capable of receiving breast radiotherapy (not pregnant, no history of previous radiotherapy to the same breast, no connective tissue disorder)

The following factors will disqualify you from participating in the Targit Trial:
· You have multiple areas of cancer within your breast.
· You have cancer in both of your breasts.
· Your diagnostic biopsy shows extensive non-invasive cancer (DCIS or Ductal Carcinoma in Situ).
· You lymph nodes contain cancer metastasis.

2. Informed Consent: If you qualifying for the Targit Trial, you will be given an Informed Consent statement that clearly describes important aspects of the Targit Trial, including the benefits and risks of the different treatments. The trial investigators will review the Informed Consent statement with you, answer any questions that you have, and request that you sign the Informed Consent statement to confirm willingness to participate in the Targit Trial. By signing of the Informed Consent statement you indicate that you are interested in participating in the Targit Trial and that you are willing to receive whichever treatment assigned to you.

3. Randomization: After signing the Informed Consent statement, a computer that will randomly assign one of the two treatments to you in a process similar to flipping a coin. Half of the participants will receive Single-Day Targeted Intraoperative Radiotherapy and half will receive Conventional Postoperative Radiotherapy. To ensure the integrity of the study, neither you nor your doctor will be permitted to determine which treatment you will receive.

4. Scheduling of Surgery: After treatment has been determined, you, the surgeon, and the radiation oncologist will schedule the date of your operation. If you have been assigned to receive Single-Day Targeted Intraoperative Radiotherapy, you will receive Targeted Intraoperative Radiotherapy at the time of your breast cancer surgery while you are still under anesthesia. The radiotherapy treatment will take approximately 30-35 and will add approximately 45 minutes to the length of the operation. On the other hand, if you have been assigned to receive Conventional Postoperative Radiotherapy, you will receive Conventional Postoperative Radiotherapy over a 6-7 week period after you have recovered from breast surgery.