Programs and Projects
Breast Cancer Prevention Clinical Trials
Ongoing Phase II Prevention Trials Monitored by the Breast and Gynecologic Cancer Research Group (BGCRG)
Contracts
| Principal Investigator |
Institution |
Title of Award |
Chemopreventive Agent |
BGCRG Medical Monitor |
| Dawn Hershman, M.D.** |
Columbia University |
Phase 1b Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with a History of Hormone Receptor-Negative Breast Cancer |
Polyphenon E |
Doris Browne, M.D. |
| Sherry Chow, Ph.D |
University of Arizona |
A Phase IB Sulindac Study for Women at High Risk Breast Cancer |
Sulindac |
Doris Browne, M.D. |
| Ray Bergan, M.D. |
Northwestern University |
A Phase IIB Trial of G - 2535
(Unconjugated Isoflavones -100) in Women at High Risk Breast Cancer |
G - 2535 (Unconjugated Isoflavones -100)
Placebo |
Doris Browne, M.D. |
| Carol J. Fabian, M.D. |
University of Kansas Medical Center |
A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer |
Celecoxib |
Doris Browne, M.D. |
| Carol J. Fabian, M.D. |
University of Kansas Medical Center |
A Phase IB Randomized Multiple-Dose Safety, Pharmacodynamic (Biomarker Modulation) Study of LY353381-HCL- A Selective Estrogen Receptor Modulator (SERM) in Women with Newly Diagnosed Breast Cancer |
SERM-3 (Arzoxifene)
Placebo |
Doris Browne, M.D. |
| David Euhus, M.D. |
U.T. Southwestern Medical Center
Dallas, Texas |
An Exploratory Study to Identify Potential Surrogate Endpoint Biomarkers That are Modulated by Tamoxifen vs. Placebo in Women with an Increased Risk for Breast Cancer |
Tamoxifen
Placebo |
Doris Browne, M.D. |
| Banu Arun, M.D.** |
MD Anderson |
A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer |
Atorvastatin |
|
| Carol J. Fabian, M.D. |
University of Kansas Medical Center |
Phase II Study of Acolbifene in Premenopausal Women at High Risk for Breast Cancer |
Acolbifene HCL |
Doris Browne, M.D. |
| Howard Bailey, M.D.** |
University of Wisconsin |
A Pilot Study of the Novel Retinoid, 9cUAB30 to Determine Preliminary Pharmacokinetics |
9-cis-UAB30 |
Doris Browne, M.D. |
|
** indicates that the contract/cooperative agreements are open to accrual
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Cooperative Agreements
| Principal Investigator |
Institution |
Title of Award |
Chemopreventive Agent |
BGCRG Medical Monitor |
| Carol J. Fabian, M.D. |
University of Kansas Medical Center |
A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY35381-HCL) in High Risk Women with Fine Needle Aspiration Cytologic Evidence of Hyperplasia |
SERM-3 (Arzoxifene) |
Doris Browne, M.D. |
| Richard Elledge, M.D. |
Baylor College of Medicine |
A Multi-center, Randomized, Double Blind Trial of Targretin Capsules for Modifying Immunophenotypic Markers Related to Breast Cancer: Progression in Breast Tissue from Genetically Identified High Risk Patients |
Targretin
Placebo |
Karen Johnson, M.D. |
| Andrea Decensi, M.D. |
European Institute of Oncology |
Low Dose Tamoxifen and 4-HPR in Early Breast Cancer |
Tamoxifen
4-HPR (Fenretinide)
Placebo |
Karen Johnson, M.D. |
|
** indicates that the contract/cooperative agreements are open to accrual
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Other
| Principal Investigator |
Institution |
Title of Award |
Chemopreventive Agent |
BGCRG Medical Monitor |
| Jennifer Eng-Wong, M.D.** |
Georgetown University Medical Center |
Trial of Exemestane in Post-menopausal Women with DCIS or at High Risk for Invasive Breast Cancer |
Exemestane
Placebo |
Karen Johnson, M.D. |
|
** indicates that the contract/cooperative agreements are open to accrual
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This page was last updated on June 15, 2008.
