In September, we recognize Gynecologic Cancer Awareness Month by highlighting a new clinical trial enrolling patients with endometrial cancer, the most prevalent gynecologic cancer in the United States. This phase II study offered by Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, is designed for patients with grade 1 endometrioid endometrial cancer.
Researchers will evaluate the efficacy and safety of giredestrant, a therapeutic agent being developed as a treatment for both ER-positive breast and endometrial cancers. Given orally, giredestrant acts as a selective estrogen receptor degrader by targeting the estrogen receptor.
Why this study is important
In general, the first approach to treating patients with endometrial cancer is a total hysterectomy and bilateral salpingo-oophorectomy with lymphadenectomy. Additionally, hormone therapy is an option for patients who are medically poor candidates for surgery and pre-menopausal patients who want to preserve fertility.
High dose therapeutic progestin is the standard hormone therapy, countering the effect of estrogen in the endometrium. Although initially effective, there are numerous side effects that make it challenging for patients to adhere to the treatment. As a result, there is a high rate of endometrial cancer relapse in patients who choose this therapeutic approach.
Another effective treatment option is needed for patients with endometrial cancer. This study is an effort to fill that gap by testing the hypothesis that treatment with giredestrant will lead to complete regression of endometrioid endometrial cancer.
Treatment in 28 days, six cycles
The trial will enroll approximately 45 participants at sites in Canada, Italy, Poland and the U.S. Regression within six months is the primary endpoint.
Patients will receive 30 milligrams of giredestrant once daily for 28 days in six cycles. After completing six cycles, the patient and investigator can choose to continue the study therapy or discontinue the study therapy and receive care determined by the investigator.
Patients can stop after six months of taking the medication and proceed with surgery. They also have the option to continue receiving the study treatment for up to 18 additional cycles.
Providence Cancer Institute is currently enrolling patients with grade 1 endometrioid endometrial cancer for this study. Christopher Darus, M.D., MS, medical director, Providence Gynecologic Oncology Program, is the principal investigator.
Learn more about the study here:
A Phase II, Single-Arm Study of Giredestrant in Patients with Grade 1 Endometrial Cancer
Refer a patient.
To refer a patient to this or other clinical trials, contact our clinical research office:
- Call 503-215-2614
- Submit a referral form
- Email CanRsrchStudies@providence.org
New research studies are added frequently. To see more clinical studies, visit:
- Studies for gynecologic studies
- Studies for many types of cancer and advanced cancers
- All cancer studies at Providence Cancer Institute
Exceptional gynecologic cancer care
The Providence Gynecologic Oncology Program provides specialized care for women with suspected or known gynecologic malignancies and complex precancerous conditions. Patients have access to advanced treatments such as robotic surgery and immunotherapy, and the latest research and clinical trials. We offer comprehensive care at two locations: Robert W. Franz Cancer Center at Providence Portland Medical Center and Providence St. Vincent Medical Center. Learn more.
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