Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy
NCT ID: NCT01437566
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2011-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Study Groups
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GDC-0941 Matching Placebo + Fulvestrant (Arm E)
Participants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 matching placebo QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941 Matching Placebo
Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941-260 mg + Fulvestrant (Arm D)
Participants with PIK3CA mutation will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 260 mg QD orally starting on Day 1 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941
Participants will receive GDC-0941 260 mg (Part II) or 340 mg (Part I) QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941-340 mg + Fulvestrant (Arm A)
Participants will receive fulvestrant 500 milligrams (mg) as 2 intramuscular (IM) injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0941 340 mg once daily (QD) orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941
Participants will receive GDC-0941 260 mg (Part II) or 340 mg (Part I) QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0948 or GDC-0980 Matching Placebo + Fulvestrant (Arm C)
Participants will be randomized in 1:1 ratio to receive GDC-0948 matching placebo or GDC-0980 matching placebo with fulvestrant. Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0948 or GDC-0980 matching placebo QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941 Matching Placebo
Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980 Matching Placebo
Participants will receive GDC-0980 matching placebo QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980-30 mg + Fulvestrant (Arm B)
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle and GDC-0980 30 mg QD orally starting on Day 15 of Cycle 1, each cycle of 28 days. Study treatment will continue until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980
Participants will receive GDC-0980 30 mg (Part I) QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Interventions
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Fulvestrant
Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941
Participants will receive GDC-0941 260 mg (Part II) or 340 mg (Part I) QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0941 Matching Placebo
Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980
Participants will receive GDC-0980 30 mg (Part I) QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
GDC-0980 Matching Placebo
Participants will receive GDC-0980 matching placebo QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
Eligibility Criteria
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Inclusion Criteria
* As per national or local treatment guidelines, endocrine therapy (i.e., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not necessary for participants, at time of entry into the study.
* Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
* Part II: Postmenopausal women with locally ABC or MBC whose disease has progressed during or after treatment with an AI. Participants who discontinued the AI for toxicity rather than completion of regimen or for disease progression are not eligible
* Estrogen receptor (ER)-positive disease and human epidermal receptor 2 (HER2)-negative disease
* Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 or bone-only disease with radiologic scans
* Adequate hematologic and end-organ function
Exclusion Criteria
* Prior anti-cancer therapy or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
* Prior treatment with greater than (\>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on \> two endocrine therapies for MBC
* Participants requiring anti-hyperglycemic therapy
* Clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease
* Active uncontrolled autoimmune disease or active inflammatory disease
* Immunocompromised status
* Need for current chronic corticosteroid therapy
* Pregnancy, lactation, or breastfeeding
* Current severe, uncontrolled systemic disease
* Symptomatic hypercalcemia
* Known untreated or active central nervous system (CNS) metastases
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gallia Levy, M.D., Ph.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Birmingham, Alabama, United States
Hayward, California, United States
Oakland, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
Santa Clara, California, United States
South San Francisco, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
Marietta, Georgia, United States
Joliet, Illinois, United States
Peoria, Illinois, United States
Wichita, Kansas, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Basking Ridge, New Jersey, United States
Hackensack, New Jersey, United States
Commack, New York, United States
New York, New York, United States
Rockville Centre, New York, United States
Sleepy Hollow, New York, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Richmond, Virginia, United States
Buenos Aires, , Argentina
Santa Fe, , Argentina
Kogarah, New South Wales, Australia
Wahroonga, New South Wales, Australia
South Brisbane, Queensland, Australia
Bedford Park, South Australia, Australia
Woodville, South Australia, Australia
Frankston, Victoria, Australia
Parkville, Victoria, Australia
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Liège, , Belgium
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Santiago, , Chile
Temuco, , Chile
Valparaíso, , Chile
Viña del Mar, , Chile
Brno, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Aarhus, , Denmark
Herlev, , Denmark
København Ø, , Denmark
Odense, , Denmark
Roskilde, , Denmark
Vejle, , Denmark
Paris, , France
Berlin, , Germany
Düsseldorf, , Germany
Freiburg im Breisgau, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
München, , Germany
München, , Germany
München, , Germany
Trier, , Germany
Hong Kong, , Hong Kong
Pokfulam, , Hong Kong
Beersheba, , Israel
Holon, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Napoli, Campania, Italy
Meldola, Emilia-Romagna, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Monza, Lombardy, Italy
Pisa, Tuscany, Italy
Prato, Tuscany, Italy
Terni, Umbria, Italy
George Town, , Malaysia
George Town, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Tanjung Bungah, , Malaysia
León, , Mexico
Christchurch, , New Zealand
Hamilton, , New Zealand
Wellington, , New Zealand
Lima, , Peru
Lima, , Peru
Lima, , Peru
Chelyabinsk, , Russia
Kazan', , Russia
Moscow, , Russia
Voronezh, , Russia
Singapore, , Singapore
Seoul, , South Korea
Barcelona, Barcelona, Spain
Lleida, Lerida, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Patumwan, , Thailand
Songkhla, , Thailand
Brighton, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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References
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Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Jun;17(6):811-821. doi: 10.1016/S1470-2045(16)00106-6. Epub 2016 May 4.
Other Identifiers
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GO00769
Identifier Type: OTHER
Identifier Source: secondary_id
2010-023763-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GDC4950g
Identifier Type: -
Identifier Source: org_study_id