FOR RESPONSE TO INQUIRIES
Tuesday, September 22, 1998
NCI Press Office
Herceptin® Lottery Ends, Trials Expand to Include More Eligible Patients
- All patients who entered the lottery before 4:30 p.m., Sept. 18, but
were not selected, will now be able to receive the drug through either
of two mechanisms. They can register to participate in the current clinical
trial (called the TRC-9801 protocol) at a participating NCI-sponsored cancer
center. Or they can register in a new treatment protocol (TP-9801) that
will allow the patient's primary oncologist to enroll the patient, administer
the drug, and follow up on that patient's care.
- Eligible patients who have not entered the lottery may receive Herceptin
through a participating cancer center on protocol TRC-9801, if waiting
for commercial release is not a reasonable option.
NCI has asked the cancer centers who participate in the ongoing treatment
protocol (TRC-9801) to contact the local oncologists of patients entered
in the lottery but not selected. The centers have been asked to notify
those doctors about the availability of Herceptin for their patients. These
patients are eligible to participate in either TRC-9801 or the new treatment
protocol (TP-9801). They also have the option of awaiting commercial availability,
which should occur soon.
To enter either protocol, all patients must have disease that has recurred
or progressed following treatment with two regimens for advanced breast
cancer that expresses the HER2 protein. There are also certain other eligibility
requirements. To obtain information regarding eligibility and cancer center
locations, patients can call NCI's Cancer Information Service (CIS) at 1-800-4-CANCER.
While a percentage of other types of cancer express HER2, there is no
experience to suggest that Herceptin can treat them. Clinical trials to
determine whether Herceptin will help in these diseases are being planned.
The FDA has made action on Herceptin a high priority. Once the drug
has FDA approval, patients will be able to obtain the drug through normal
See also: Questions and Answers About NCI's Expanded Research With Herceptin®