Breast Cancer Clinical Trial
A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Summary
This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in two parts: Dose escalation and Dose expansion. During dose escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation during the lead-in period. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose expansion, there will be no PK week lead-in period. All participants will be treated until disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
ER-positive tumor, HER2-negative breast cancer
No prior treatment with GDC-0810 (allowed only during dose expansion stage)
No more than 2 prior chemotherapies in the advanced or metastatic setting
At least 2 months must have elapsed from the use of tamoxifen
At least 6 months must have elapsed from the use of fulvestrant
At least 2 weeks must have elapsed from the use of any other endocrine therapy
At least 3 weeks must have elapsed from the use of any chemotherapy
Females, 18 years of age or older
Postmenopausal status as defined by the protocol
Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to (=) 2 (for dose-escalation part) and 0 or 1 (for dose-expansion part)
Adequate organ function
Exclusion Criteria:
Untreated or symptomatic brain metastases
Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of Grade greater than or equal to (>/=) 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack
Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
Known Human Immunodeficiency Virus (HIV) infection
Major surgery within 4 weeks prior to enrollment
Radiation therapy within 2 weeks prior to enrollment
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 13 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
New York New York, 10065, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
L'Hospitalet de Llobregat Barcelona, 08908, Spain
San Sebastian Guipuzcoa, 20014, Spain
Barcelona , 08035, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.