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A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy (HydranGea)

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ClinicalTrials.gov Identifier: NCT02569801
Recruitment Status : Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Drug: GDC-0810 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 4, 2015
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
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.
 Drug: GDC-0810
GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
Other Name: RO7056118


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. Apparent Oral Clearance (CL/F) of GDC-0810 [ 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 ]
  7. Apparent Volume of Distribution (Vz/F) of GDC-0810 [ 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 ]
  8. Absorption Rate Constant (Ka) of GDC-0810 [ 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569801


  Show 44 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02569801     History of Changes
Other Study ID Numbers: GO29689
2015-000106-19 ( EudraCT Number )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action