Robert L. Comis, MD

1) On behalf of the Coalition of Cancer Cooperative Groups
BCRF funding will be applied to a project designed to support clinical researchers striving to increase participation in breast cancer clinical trials. The project assists researchers at minority-based community US cancer programs in an initiative to increase screening and enrollment rates for minority breast cancer patients whom they serve, and to assist these researchers identifying the precise barriers to minority-based enrollment onto breast cancer studies among their patients.

While national rates of minority participation remain dismally low, little is known about the numbers of minority women who are screened for possible participation in clinical trials and the reasons why they are either ineligible or choose not to participate. Using an electronic screening and tracking system employed at point-of-care, clinicians can identify the precise barriers to participation, both for specific patients and their full patient population. The information gathered provides evidence-based data as to the reasons for non-accrual that can be used at the sites in the formation of intervention strategies that correspond to specific needs. Ultimately, it is hoped that this information will lead to increased minority participation in breast cancer studies.

Mid-Year Progress Report:
Dr. Comis reports that the two participating sites, Meharry Medical College, Nashville, Tennessee, and John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, continue to actively participate in the study and to provide data, which will be further analyzed and updated over the next several months. Full-scale outreach and education efforts are in place and on schedule to expand the pool of participating sites. Criteria for sites to become a participating partner are: 1) actively participate in oncology trials; 2) have a strong minority population from which they draw patients; and 3) interest in using TrialCheck® and TrialTracker electronic software to screen and track all oncology patients, including breast cancer patients. Interested sites may contact Scott Himmelmann, Project Manager, at scott@studyhallinc.com. Other planned efforts include implementation, education and training with the new partners, and continued support to the two ongoing sites, both of whom have indicated they will remain engaged in the project over the long term.

2) On behalf of the Eastern Oncology Cooperative Group
The Eastern Cooperative Oncology Group’s Breast Cancer Committee performs cutting-edge clinical trials in the early and advanced stage settings. These trials are NCI-funded, but little or no funding is provided by NCI for important correlative laboratory work. In the current era, when the laboratory work provides a crucial lens through which clinical trials are examined, this is an important missing piece of clinical breast cancer research.

The ECOG Breast Committee, with support from BCRF, continues to perform correlative laboratory studies attached to cutting-edge clinical trials. These trials include E4101, an ongoing trial examining whether the addition of the EGFR-blocking drug gefitinib (Iressa) to estrogen receptor-targeting therapy (with either anastrazole or fulvestrant) may augment standard therapies and prevent the development of drug resistance. This trial recently closed to accrual, and performance of the biomarker studies has begun.

BCRF funding has also been crucial to the performance of important correlative laboratory studies for E2100, a pivotal trial of anti-angiogenic (blood-vessel-targeting) therapy in breast cancer. This trial is now closed to accrual but patients who entered into the trial continue to supply serum, urine, and tumor block material. Analysis of serum and urine is ongoing. These correlative laboratory studies will provide important on-study information as well as offering the prospect of improved therapeutic individualization. TAILORx is a trial involving the use of a new diagnostic test, Oncotype DX, to determine treatment assignment. Its goal is to establish a mechanism to identify who benefits from chemotherapy.

BCRF funds this year will also support correlative studies associated with two phase III studies to be activated this year, to determine the possible benefits of adding anti-angiogenic therapy to first-line chemotherapy. E5103 will focus on patients with HER2/neu-negative, lymph node-positive or high risk, lymph node-negative breast cancer. E1105 will evaluate patients with breast cancer that over-expresses HER2/neu.

BCRF funds are also currently being used to help prepare previously collected paraffin-embedded tissues for genomic analysis, using a novel technology to analyze the role of as many as 200 genes in breast cancer recurrence and response to therapy. Such genomic analysis has the potential to revolutionize treatment of breast cancer, by virtue of allowing individualization of patient therapy.

Mid-Year Progress Report:
The ECOG Breast Committee, with the support of BCRF, continues to perform correlative laboratory studies attached to cutting edge clinical trials. These trials include E4101, a trial now closed to accrual, which examines whether the addition of the EGFR-blocking drug gefitinib (Iressa) to estrogen receptor-targeting therapy (with either anastrazole or fulvestrant) may augment standard therapies and prevent the development of drug resistance. The supported correlative studies are conducted by Dr. Sunil Badve.

BCRF funding has also been crucial to the performance of important correlative laboratory studies for E2100, a pivotal trial of anti-angiogenic (blood-vessel-targeting) therapy in breast cancer. This trial is now closed to accrual but patients who entered into the trial supplied serum, urine, and tumor block material. Analysis of serum and urine is ongoing under the direction of Dr. George Sledge and Dr. Kathy Miller, and tumor analysis is performed under the direction of Dr. Ann Thor. These correlative laboratory studies are close to completion and will determine whether the markers studied can be used to help develop patient-specific treatment. These samples are also being used to establish tumor marker profiles identifying cancers that may benefit from treatments that inhibit the growth of blood vessels in the tumors.

BCRF funding is also instrumental in the management of tissue and blood samples submitted from patients participating in the PACCT-1/TAILORx trial. The TAILORx trial will use modern diagnostic testing (the Oncotype DX Recurrence Score by Genomic Health) to analyze a piece of the breast cancer tumor and assign treatment based upon the test results. This trial is one of the largest adjuvant trials ever performed and the information and tissue samples collected during the trial will be used to determine which patients would be more likely to benefit from chemotherapy and reduce the use of chemotherapy treatment in those who are unlikely to benefit from it.

BCRF funds are also currently being used to support initial costs associated with the submission of tissue and blood for two large phase III studies which recently opened: E5103 (an adjuvant trial testing the role of anti-angiogenic therapy in early-stage breast cancer) and E1105 (the effect of anti-angiogenic therapy in combination of front-line treatment of HER2-positive metastatic breast cancer). BCRF also supports the processing of previously collected tissue and blood samples for genomic analysis and other important laboratory research studies.

Bio:
Robert L. Comis, MD, President and Chairman of the Coalition of National Cancer Cooperative Groups, Inc., is Professor of Medicine and Director of the Drexel University Clinical Trials Research Center, Philadelphia, and the Group Chair of the Eastern Cooperative Oncology Group (ECOG).

A leader in national clinical trials research since 1977, Dr. Comis has been actively involved in increasing the awareness of the pivotal role cancer clinical trials has in cancer treatment. Dr. Comis was appointed Chair, Clinical Trials Team of the NDC and was elected to the Board of the American Society of Clinical Oncology (ASCO), the American Radium Society (ARS) and the National Coalition for Cancer Research (NCCR). Dr. Comis is a Diplomat of the American Board of Internal Medicine, a member of the International Program Committee of the American Radium Society, and Chairman of the Nominating Committee of the American Association for Cancer Research, Inc.