Breast CancerPhase 2HydranGeaNCT02569801
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
A Phase 2 study testing Fulvestrant and GDC-0810 in people with Breast Cancer, run by Genentech, Inc. at 44 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fulvestrant and GDC-0810
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 4 Dec 2015to 28 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
Spain10 sites
Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia
A Coruña, LA Coruña, 15006
Hospital Clinic
Barcelona, Cantabria, 08036
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitari Arnau de Vilanova
Lleida, Lerida, 25198
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hosp. Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States7 sites
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Florida Cancer Specialists-Broadway, Fort Myers
Fort Myers, Florida, 33908
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104
Tennessee Oncology PLLC
Franklin, Tennessee, 37067
MD Anderson Cancer Center
Houston, Texas, 77030
Yale Cancer Center
New Haven, Connecticut, 06520
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, 33705
Australia7 sites
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Footscray Hospital
Footscray, Victoria, 3011
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Royal Hobart Hospital; Medical Oncology
Hobart, Tasmania, 7000
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Epworth HealthCare; Clinical Trials Centre
Richmond, Victoria, 3121
Germany7 sites
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla
Koblenz, 56068
HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
Krefeld, 47805
Rotkreuzklinikum München; Frauenklinik
München, 80637
Universitätsklinikum Tübingen
Tübingen, 72076
Marien Hospital Witten Gemeinnützige GmbH
Witten, 58452
United Kingdom7 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Western General Hospital
Edinburgh, EH4 2XU
St Bartholomew's Hospital
London, EC1A 7BE
University College Hospital
London, N7 9NH
Sarah Cannon Research Institute
London, W1G 6AD
Macclesfield District General Hospital
Macclesfield, SK10 3BL
Nottingham City Hospital
Nottingham, NG5 1PB
South Korea6 sites
Kyungpook National University Medical Center
Daegu, 41404
National Cancer Center
Goyang-si, 10408
Samsung Medical Center
Seoul, (0)6351
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea University Guro Hospital
Seoul, 08308
Ulsan University Hosiptal
Ulsan, 44033
About this study
Official 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
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.
- Conditions
- Breast Cancer
- Being tested
- Fulvestrant, GDC-0810
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
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.
GDC-0810Drug
Also called RO7056118
GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Fulvestrant | Active comparator | 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. Receives: Drug: Fulvestrant |
| GDC-0810 | Experimental | 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. Receives: Drug: GDC-0810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
Objective Response was defined as the percentage of participants who attained CR or PR. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Duration of Response (DOR) Assessed Using RECIST v1.1
DOR was defined as the time from first observation of an objective response until first observation of disease progression as assessed by the investigator according to RECIST v1.1 or death from any cause.
Measured: From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
Measured: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)
GDC-0810 Plasma Concentrations by Visit
Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1)
Measured: Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start4 Dec 2015
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569801
- Sponsor's protocol ID
- GO29689
- Other IDs
- 2015-000106-19, 2015
- Acronym
- HydranGea
- Status last verified
- Apr 2021
- First submitted
- 6 Oct 2015
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02569801
- Acronym / sponsor ID
- HydranGea / GO29689
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fulvestrant | Active comparator | Drug: FulvestrantParticipants 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. |
| GDC-0810 | Experimental | Drug: GDC-0810Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantFulvestrant 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. | Drug | Fulvestrant |
| GDC-0810Also: RO7056118GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily. | Drug | GDC-0810 |
Primary outcome
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
6 secondary outcomes
Overall Survival (OS)
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Duration of Response (DOR) Assessed Using RECIST v1.1
Time frame: From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)
GDC-0810 Plasma Concentrations by Visit
Time frame: Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant and GDC-0810 in people with Breast Cancer, run by Genentech, Inc. at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, United States, Australia, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population (time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.