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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

Study category: Cancer

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Description

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

Details
Age

Adult

Eligibility

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

Detailed Eligibility: 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 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

Phase

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.

Type of Study

Basic Science

Locations

Lone Tree Medical Center
University of Colorado Hospital

Principal Investigator
Peter Kabos,  MD

Peter Kabos, MD

Study ID

Protocol Number: 19-0206

More information available at ClinicalTrials.gov: NCT03916744

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