Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01437566
First received: September 8, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Patients with advanced or Metastatic Breast Cancer (MBC) who have previously received treatment with an aromatase inhibitor. Patients will receive treatment with GDC-0941 + fulvestrant or GDC-0980 + fulvestrant or placebo + fulvestrant.


Condition Intervention Phase
Breast Cancer
Drug: GDC-0941
Drug: placebo
Drug: fulvestrant
Drug: GDC-0980
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (PFS) as assessed by the investigator per modified RECIST version 1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response as assessed by the investigator per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Clinical benefit defined as partial response (PR), complete response (CR), or stable disease (SD) per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Duration of confirmed objective response as assessed by the investigator per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients with PIK3CA mutant tumors [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: time to maximum concentration [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: maximum concentration [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: Area under the concentration time curve [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: October 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D Drug: GDC-0941
Repeating oral dose
Drug: fulvestrant
Repeating intramuscular injection
Placebo Comparator: E Drug: placebo
Repeating oral dose
Drug: fulvestrant
Repeating intramuscular injection
Experimental: A Drug: fulvestrant
Repeating intramuscular injection
Drug: GDC-0941
Repeating oral dose
Experimental: B Drug: fulvestrant
Repeating intramuscular injection
Drug: GDC-0980
Repeating oral dose
Placebo Comparator: C Drug: fulvestrant
Repeating intramuscular injection
Drug: placebo
Repeating oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ER-positive locally advanced breast cancer or Metastatic Breast Cancer (MBC). Postmenopausal women with locally advanced breast cancer or Metastatic Breast Cancer whose disease has progressed during or after treatment with an aromatase inhibitor. Part II: Postmenopausal women with locally advanced PIK3CA-mutant breast cancer or PIK3CA-mutant MBC that has progressed during or after treatment with an AI.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patients must have measurable disease by RECIST v1.1 or bone-only disease
  • Adequate hematologic and end-organ function
  • Estrogen receptor-positive disease and HER2-negative disease

Exclusion Criteria:

  • Prior treatment with fulvestrant, PI3K inhibitor, or mTOR inhibitor for advanced breast cancer or MBC
  • Prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • History of clinically significant cardiac or pulmonary dysfunction
  • Clinically significant history of liver disease
  • Active uncontrolled autoimmune disease or active inflammatory disease
  • Immunocompromised status
  • Symptomatic hypercalcemia
  • Need for current chronic corticosteroid therapy
  • Pregnancy, lactation, or breastfeeding
  • Known untreated or active central nervous system (CNS) metastases Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437566

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Hayward, California, United States, 94545
Oakland, California, United States, 94611
Roseville, California, United States, 95661
Sacramento, California, United States, 95825
San Francisco, California, United States, 94115
San Jose, California, United States, 95119
Santa Clara, California, United States, 95051
South San Francisco, California, United States, 94080
Vallejo, California, United States, 94589
Walnut Creek, California, United States, 94596
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Boca Raton, Florida, United States, 33428
Fort Myers, Florida, United States, 33916
Jacksonville, Florida, United States, 32224
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Joliet, Illinois, United States, 60435
Peoria, Illinois, United States, 61615
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis, Missouri, United States, 63128
United States, New Jersey
Basking Ridge, New Jersey, United States, 07920
Hackensack, New Jersey, United States, 07601
United States, New York
Commack, New York, United States, 11725
New York, New York, United States, 10065
Rockville Centre, New York, United States, 11570
Sleepy Hollow, New York, United States, 10591
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37211
United States, Texas
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
Houston, Texas, United States, 77030-4095
Tyler, Texas, United States, 75702
United States, Virginia
Richmond, Virginia, United States, 23230
Argentina
Caba, Argentina, C1050AAK
Santa Fe, Argentina, 03000
Australia, New South Wales
Kogarah, New South Wales, Australia, 2217
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Milton, Queensland, Australia, 4064
Australia, South Australia
Bedford Park, South Australia, Australia, 5042
Woodville, South Australia, Australia, 5011
Australia, Victoria
Frankston, Victoria, Australia, 3199
Parkville, Victoria, Australia, 3050
Belgium
Anderlecht, Belgium, 1070
Bruxelles, Belgium, 1000
Edegem, Belgium, 2650
Leuven, Belgium, 3000
Liege, Belgium, 4000
Canada, Quebec
Montreal, Quebec, Canada, H3G 1A4
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
Santiago, Chile, 7630370
Temuco, Chile, 4810469
Valparaiso, Chile, 2341391
Vina del Mar, Chile, 2540364
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 775 20
Praha, Czech Republic, 128 08
Denmark
Herlev, Denmark, 2730
København, Denmark, 2100
Odense, Denmark, 5000
Roskilde, Denmark, 4000
Vejle, Denmark, 7100
Århus, Denmark, 8000
France
Paris, France, 75231
Germany
Berlin, Germany, 13125
Düsseldorf, Germany, 40225
Freiburg, Germany, 79110
Freiburg, Germany, 79106
Hamburg, Germany, 20246
Muenchen, Germany, 81675
Muenchen, Germany, 81377
München, Germany, 80336
Trier, Germany, 54290
Hong Kong
Hong Kong, Hong Kong, 852
Pokfulam, Hong Kong
Israel
Beer Sheva, Israel, 8410101
Holon, Israel, 58100
Jerusalem, Israel, 91120
Jerusalem, Israel, 91031
Kfar-Saba, Israel, 4428164
Rehovot, Israel, 7610001
Tel Aviv, Israel, 6423906
Tel-Hashomer, Israel, 52621
Zerifin, Israel, 70300
Italy
Napoli, Campania, Italy, 80131
Meldola, Emilia-Romagna, Italy, 47014
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20121
Monza, Lombardia, Italy, 20052
Pisa, Toscana, Italy, 56100
Prato, Toscana, Italy, 59100
Terni, Umbria, Italy, 05100
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Malaysia
Kuala Lumpur, Malaysia, 56000
Kuala Lumpur, Malaysia, 59100
Penang, Malaysia, 10400
Penang, Malaysia, 10050
Tanjung Bungah, Malaysia, 11200
Mexico
León, Mexico, 37000
New Zealand
Christchurch, New Zealand
Hamilton, New Zealand, 3240
Wellington, New Zealand, 0621
Peru
Lima, Peru, Lima 27
Lima, Peru, 11
Lima, Peru, 34
Russian Federation
Chelyabinsk, Russian Federation, 454087
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Voronezh, Russian Federation, 394000
Singapore
Singapore, Singapore, 119074
Spain
Barcelona, Spain, 08035
Lerida, Spain, 25198
Valencia, Spain, 46015
Zaragoza, Spain, 50009
Thailand
Patumwan, Thailand, 10330
Songkhla, Thailand, 90110
United Kingdom
Brighton, United Kingdom, BN1 9PX
Cardiff, United Kingdom, CF14 2TL
London, United Kingdom, SW3 6JJ
London, United Kingdom, W1G 6AD
Stoke on Trent, United Kingdom, ST4 7LN
Sponsors and Collaborators
Genentech
Investigators
Study Director: Gallia Levy, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01437566     History of Changes
Other Study ID Numbers: GDC4950g, GO00769, 2010-023763-17
Study First Received: September 8, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014