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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02569801




Registration number
NCT02569801
Ethics application status
Date submitted
6/10/2015
Date registered
7/10/2015
Date last updated
23/03/2020

Titles & IDs
Public title
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Scientific title
A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy
Secondary ID [1] 0 0
2015-000106-19
Secondary ID [2] 0 0
GO29689
Universal Trial Number (UTN)
Trial acronym
HydranGea
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fulvestrant
Treatment: Drugs - GDC-0810

Active Comparator: Fulvestrant - Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.

Experimental: GDC-0810 - Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.


Treatment: Drugs: Fulvestrant
Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.

Treatment: Drugs: GDC-0810
GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population
Timepoint [1] 0 0
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Primary outcome [2] 0 0
PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations
Timepoint [2] 0 0
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
Timepoint [2] 0 0
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcome [3] 0 0
Duration of Response (DOR) Assessed Using RECIST v1.1
Timepoint [3] 0 0
From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcome [4] 0 0
Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
Timepoint [4] 0 0
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Timepoint [5] 0 0
From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)
Secondary outcome [6] 0 0
Apparent Oral Clearance (CL/F) of GDC-0810
Timepoint [6] 0 0
Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Secondary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F) of GDC-0810
Timepoint [7] 0 0
Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Secondary outcome [8] 0 0
Absorption Rate Constant (Ka) of GDC-0810
Timepoint [8] 0 0
Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days

Eligibility
Key inclusion criteria
- Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER-
(defined by local guidelines) metastatic or inoperable, locally advance breast cancer

- Participants for whom endocrine therapy is recommended and treatment with cytotoxic
chemotherapy is not indicated at time of entry into the study

- Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable
disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic
scans within 28 days of Day 1 of Cycle 1

- Participants with radiologic/objective evidence of breast cancer recurrence or
progression while on or within 6 months after the end of adjuvant treatment with an
AI, or progression while on or within 1 month after the end of prior AI treatment for
locally advanced or metastatic breast cancer
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- HER2-positive disease

- Prior treatment with fulvestrant

- Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine
therapies for advanced or metastatic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [4] 0 0
Royal Hobart Hospital; Medical Oncology - Hobart
Recruitment hospital [5] 0 0
Footscray Hospital - Footscray
Recruitment hospital [6] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [7] 0 0
Epworth HealthCare; Clinical Trials Centre - Richmond
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Germany
State/province [6] 0 0
Dresden
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Germany
State/province [8] 0 0
Koblenz
Country [9] 0 0
Germany
State/province [9] 0 0
Krefeld
Country [10] 0 0
Germany
State/province [10] 0 0
Muenchen
Country [11] 0 0
Germany
State/province [11] 0 0
Tuebingen
Country [12] 0 0
Germany
State/province [12] 0 0
Witten
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Daegu
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi-do
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Ulsan
Country [17] 0 0
Spain
State/province [17] 0 0
Cantabria
Country [18] 0 0
Spain
State/province [18] 0 0
LA Coruña
Country [19] 0 0
Spain
State/province [19] 0 0
Lerida
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Valencia
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Brighton
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Edinburgh
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Macclesfield
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of
GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic
estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-)
breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the
Sponsor and the enrollment in this study has been discontinued. Participants currently
enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810
as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity,
withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the
Sponsor.
Trial website
https://clinicaltrials.gov/show/NCT02569801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02569801