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.

View Eligibility Criteria

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 ( 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT02316509

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 13 Locations for this study

See Locations Near You

Massachusetts General Hospital.
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Sarah Cannon Cancer Center
Germantown Tennessee, 38138, United States
Vanderbilt Ingram Cancer Ctr
Nashville Tennessee, 37232, United States
ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Onkologikoa - Kutxaren Institutu Onkologikoa
San Sebastian Guipuzcoa, 20014, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
MD Anderson Cancer Center Madrid - España; Servicio de Farmacia
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28040, Spain
HM Sanchinarro - CIOCC
Madrid , 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT02316509

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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