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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01437566
First received: September 8, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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

Estimated Enrollment: 270
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437566

Contacts
Contact: Reference Study ID Number: GDC4950g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, California
Active, not recruiting
Hayward, California, United States, 94545
Active, not recruiting
Oakland, California, United States, 94611
Active, not recruiting
Roseville, California, United States, 95661
Active, not recruiting
Sacramento, California, United States, 95825
Active, not recruiting
San Francisco, California, United States, 94115
Active, not recruiting
San Jose, California, United States, 95119
Active, not recruiting
Santa Clara, California, United States, 95051
Active, not recruiting
South San Francisco, California, United States, 94080
Active, not recruiting
Vallejo, California, United States, 94589
Active, not recruiting
Walnut Creek, California, United States, 94596
United States, District of Columbia
Completed
Washington, District of Columbia, United States, 20010
United States, Florida
Active, not recruiting
Boca Raton, Florida, United States, 33428
Active, not recruiting
Fort Myers, Florida, United States, 33916
Completed
Jacksonville, Florida, United States, 32224
Active, not recruiting
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Completed
Joliet, Illinois, United States, 60435
Active, not recruiting
Peoria, Illinois, United States, 61615
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214-3728
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02115
Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Active, not recruiting
St. Louis, Missouri, United States, 63128
United States, New Jersey
Active, not recruiting
Basking Ridge, New Jersey, United States, 07920
Completed
Hackensack, New Jersey, United States, 07601
United States, New York
Active, not recruiting
Commack, New York, United States, 11725
Active, not recruiting
New York, New York, United States, 10065
Active, not recruiting
Rockville Centre, New York, United States, 11570
Active, not recruiting
Sleepy Hollow, New York, United States, 10591
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Completed
Charleston, South Carolina, United States, 29425
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States, 37404
Active, not recruiting
Memphis, Tennessee, United States, 38120
Active, not recruiting
Nashville, Tennessee, United States, 37232
Recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Active, not recruiting
Dallas, Texas, United States, 75246
Active, not recruiting
Fort Worth, Texas, United States, 76104
Recruiting
Houston, Texas, United States, 77030
Active, not recruiting
Houston, Texas, United States, 77030-4095
Completed
Tyler, Texas, United States, 75702
United States, Virginia
Active, not recruiting
Richmond, Virginia, United States, 23230
Argentina
Completed
Caba, Argentina, C1050AAK
Completed
Santa Fe, Argentina, 03000
Australia, New South Wales
Recruiting
Kogarah, New South Wales, Australia, 2217
Active, not recruiting
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Active, not recruiting
Milton, Queensland, Australia, 4064
Australia, South Australia
Completed
Bedford Park, South Australia, Australia, 5042
Active, not recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Active, not recruiting
Frankston, Victoria, Australia, 3199
Active, not recruiting
Parkville, Victoria, Australia, 3050
Belgium
Active, not recruiting
Anderlecht, Belgium, 1070
Active, not recruiting
Bruxelles, Belgium, 1000
Recruiting
Edegem, Belgium, 2650
Active, not recruiting
Leuven, Belgium, 3000
Active, not recruiting
Liege, Belgium, 4000
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H3G 1A4
Completed
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Completed
Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
Active, not recruiting
Santiago, Chile, 7630370
Recruiting
Temuco, Chile, 4810469
Active, not recruiting
Valparaiso, Chile, 2341391
Active, not recruiting
Vina del Mar, Chile, 2540364
Czech Republic
Active, not recruiting
Brno, Czech Republic, 656 53
Active, not recruiting
Olomouc, Czech Republic, 775 20
Active, not recruiting
Praha, Czech Republic, 128 08
Denmark
Active, not recruiting
Herlev, Denmark, 2730
Active, not recruiting
København, Denmark, 2100
Active, not recruiting
Odense, Denmark, 5000
Active, not recruiting
Roskilde, Denmark, 4000
Active, not recruiting
Vejle, Denmark, 7100
Active, not recruiting
Århus, Denmark, 8000
France
Active, not recruiting
Paris, France, 75231
Germany
Recruiting
Berlin, Germany, 13125
Recruiting
Düsseldorf, Germany, 40225
Active, not recruiting
Freiburg, Germany, 79110
Active, not recruiting
Freiburg, Germany, 79106
Active, not recruiting
Hamburg, Germany, 20246
Active, not recruiting
Muenchen, Germany, 81675
Recruiting
Muenchen, Germany, 81377
Recruiting
München, Germany, 80336
Active, not recruiting
Trier, Germany, 54290
Hong Kong
Active, not recruiting
Hong Kong, Hong Kong, 852
Active, not recruiting
Pokfulam, Hong Kong
Israel
Active, not recruiting
Beer Sheva, Israel, 8410101
Active, not recruiting
Holon, Israel, 58100
Completed
Jerusalem, Israel, 91120
Active, not recruiting
Jerusalem, Israel, 9372212
Recruiting
Kfar-Saba, Israel, 4428164
Active, not recruiting
Rehovot, Israel, 7610001
Recruiting
Tel Aviv, Israel, 6423906
Active, not recruiting
Tel-Hashomer, Israel, 52621
Recruiting
Zerifin, Israel, 70300
Italy
Recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Meldola, Emilia-Romagna, Italy, 47014
Active, not recruiting
Milano, Lombardia, Italy, 20141
Recruiting
Milano, Lombardia, Italy, 20132
Recruiting
Milano, Lombardia, Italy, 20121
Active, not recruiting
Monza, Lombardia, Italy, 20052
Recruiting
Pisa, Toscana, Italy, 56100
Active, not recruiting
Prato, Toscana, Italy, 59100
Active, not recruiting
Terni, Umbria, Italy, 05100
Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of, 138-736
Malaysia
Completed
Kuala Lumpur, Malaysia, 56000
Completed
Kuala Lumpur, Malaysia, 59100
Completed
Penang, Malaysia, 10400
Active, not recruiting
Penang, Malaysia, 10050
Completed
Tanjung Bungah, Malaysia, 11200
Mexico
Active, not recruiting
León, Mexico, 37000
New Zealand
Active, not recruiting
Christchurch, New Zealand
Active, not recruiting
Hamilton, New Zealand, 3240
Completed
Wellington, New Zealand, 0621
Peru
Active, not recruiting
Lima, Peru, Lima 27
Recruiting
Lima, Peru, 11
Completed
Lima, Peru, 34
Russian Federation
Recruiting
Chelyabinsk, Russian Federation, 454087
Active, not recruiting
Kazan, Russian Federation, 420029
Recruiting
Moscow, Russian Federation, 115478
Recruiting
Voronezh, Russian Federation, 394000
Singapore
Active, not recruiting
Singapore, Singapore, 119074
Spain
Active, not recruiting
Barcelona, Spain, 08035
Active, not recruiting
Lerida, Spain, 25198
Active, not recruiting
Valencia, Spain, 46015
Active, not recruiting
Zaragoza, Spain, 50009
Thailand
Active, not recruiting
Patumwan, Thailand, 10330
Active, not recruiting
Songkhla, Thailand, 90110
United Kingdom
Active, not recruiting
Brighton, United Kingdom, BN1 9PX
Recruiting
Cardiff, United Kingdom, CF14 2TL
Active, not recruiting
London, United Kingdom, SW3 6JJ
Active, not recruiting
London, United Kingdom, W1G 6AD
Active, not recruiting
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: August 4, 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
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014