A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE I-III OPERABLE, ESTROGEN RECEPTOR-POSITIVE BREAST CANCER
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A PHASE I, MULTICENTER, OPEN-LABEL PREOPERATIVE, SHORT-TERM WINDOW STUDY OF GDC-9545 IN POSTMENOPAUSAL WOMEN WITH STAGE IIII OPERABLE, ESTROGEN RECEPTORPOSITIVE BREAST CANCER
Adult
Histologically confirmed invasive breast carcinoma, with all of the following characteristics: – Primary tumor  1.5 cm in largest diameter by ultrasound. – Stage IIII operable breast cancer – Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice (in patients where there may be a reasonable suspicion of advanced disease [e.g., large tumors, clinically positive axillary lymph nodes] signs and symptoms)  ER-positive tumor and HER2-negative breast cancer as per local laboratory testing  Postmenopausal
Histologically confirmed invasive breast carcinoma, with all of the following characteristics: – Primary tumor 1.5 cm in largest diameter by ultrasound. – Stage IIII operable breast cancer – Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice (in patients where there may be a reasonable suspicion of advanced disease [e.g., large tumors, clinically positive axillary lymph nodes] signs and symptoms) ER-positive tumor and HER2-negative breast cancer as per local laboratory testing Postmenopausal Exclusion Criteria Patients who meet any of the following criteria will be excluded from study entry: Diagnosis of inflammatory breast cancer Concurrent use of hormone replacement therapies Previous systemic or local treatment for the primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments) Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry Current treatment with any systemic anti-cancer therapies Major surgery within 4 weeks prior to enrollment Radiation therapy within 2 weeks prior to enrollment Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal (GI) surgery including gastric resection Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytic drugs History of documented hemorrhagic diathesis or coagulopathy History or presence of symptomatic bradycardia Baseline heart rate 55 bpm prior to enrollment History or presence of sick sinus syndrome History or presence of an abnormal ECG that is clinically significant in the investigator’s opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.
Basic Science
Lone Tree Medical Center
University of Colorado Hospital
Protocol Number: 19-0206
More information available at ClinicalTrials.gov: NCT03916744
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