Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GO00769 | Other Identifier | Hoffmann-La Roche | |
| 2010-023763-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDC-0941 Matching Placebo + Fulvestrant (Arm E) | Placebo Comparator | 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. |
|
| GDC-0941-260 mg + Fulvestrant (Arm D) | Experimental | 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. |
|
| GDC-0941-340 mg + Fulvestrant (Arm A) | Experimental | 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. |
|
| GDC-0948 or GDC-0980 Matching Placebo + Fulvestrant (Arm C) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival as Assessed by the Investigator Per modified RECIST v 1.1 | From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy) | |
| Percentage of Participants with Adverse Events | Baseline to up to 30 days after the last dose of study drug (Approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Objective Tumor Response (Complete Response [CR] or Partial Response [PR] as Assessed by the Investigator Per Modified RECIST v 1.1 | From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gallia Levy, M.D., Ph.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27155741 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
| GDC-0980-30 mg + Fulvestrant (Arm B) | Experimental | 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. |
|
|
| GDC-0941 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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. |
|
| Percentage of Participants with Clinical Benefit Response Defined as PR, CR, or SD Per Modified RECIST v 1.1 |
| From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy) |
| Duration of Confirmed Objective Response as Assessed by the investigator Per Modified RECIST v 1.1 | From Screening to up to approximately 5 years (assessed at Screening, after 8, 16, 24 and 32 weeks of treatment, every 12 weeks thereafter until disease progression or initiation of other anti-cancer therapy) |
| Percentage of Participants with PIK3CA Mutant Tumors | Baseline |
| Time to Maximum Plasma Concentration (Tmax) of GDC-0941 and GDC-0948 | Part 1:0-4 hour (hr) predose (PrD), 1,2,4 hr postdose (PoD) on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1 |
| Maximum Plasma Concentration (Cmax) of GDC-0941 and GDC-0948 | Part 1:0-4 hr PrD, 1,2,4 hr PoD on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1 |
| Area Under the Concentration Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of GDC-0941 and GDC-0948 | Part 1:0-4 hr PrD, 1,2,4 hr PoD on Day 15 of Cycles 1 & 2, PrD on Cycle 1 Day 16, 0-4 hr PrD & 2 hr PoD on Cycle 6 Day 1; Part II:0-4 hr PrD, 2 hr PoD on Day 1 of Cycles 1 & 6, 0-4 hr PrD, 1, 2, 4 hr PoD on Cycle 2 Day 1 |
| Hayward |
| California |
| 94545 |
| United States |
| Oakland | California | 94611 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95825 | United States |
| San Francisco | California | 94115 | United States |
| San Jose | California | 95119 | United States |
| Santa Clara | California | 95051 | United States |
| South San Francisco | California | 94080 | United States |
| Vallejo | California | 94589 | United States |
| Walnut Creek | California | 94596 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Boca Raton | Florida | 33428 | United States |
| Fort Myers | Florida | 33916 | United States |
| Jacksonville | Florida | 32224 | United States |
| St. Petersburg | Florida | 33705 | United States |
| Marietta | Georgia | 30060 | United States |
| Joliet | Illinois | 60435 | United States |
| Peoria | Illinois | 61615 | United States |
| Wichita | Kansas | 67214-3728 | United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02215 | United States |
| St Louis | Missouri | 63128 | United States |
| Basking Ridge | New Jersey | 07920 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Commack | New York | 11725 | United States |
| New York | New York | 10065 | United States |
| Rockville Centre | New York | 11570 | United States |
| Sleepy Hollow | New York | 10591 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Charleston | South Carolina | 29425 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Germantown | Tennessee | 38138 | United States |
| Nashville | Tennessee | 37211 | United States |
| Nashville | Tennessee | 37232 | United States |
| Dallas | Texas | 75246 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030-4095 | United States |
| Houston | Texas | 77030 | United States |
| Tyler | Texas | 75702 | United States |
| Richmond | Virginia | 23226 | United States |
| Buenos Aires | 1025 | Argentina |
| Santa Fe | 03000 | Argentina |
| Kogarah | New South Wales | 2217 | Australia |
| Wahroonga | New South Wales | 2076 | Australia |
| South Brisbane | Queensland | 4101 | Australia |
| Bedford Park | South Australia | 5042 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Brussels | 1000 | Belgium |
| Brussels | 1070 | Belgium |
| Edegem | 2650 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Montreal | Quebec | H3G 1A4 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Santiago | 7630370 | Chile |
| Temuco | 4810469 | Chile |
| Valparaíso | 2341391 | Chile |
| Viña del Mar | 2540364 | Chile |
| Brno | 656 53 | Czechia |
| Olomouc | 775 20 | Czechia |
| Prague | 128 08 | Czechia |
| Aarhus | 8000 | Denmark |
| Herlev | 2730 | Denmark |
| København Ø | 2100 | Denmark |
| Odense | 5000 | Denmark |
| Roskilde | 4000 | Denmark |
| Vejle | 7100 | Denmark |
| Paris | 75231 | France |
| Berlin | 13125 | Germany |
| Düsseldorf | 40225 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Freiburg im Breisgau | 79110 | Germany |
| Hamburg | 20246 | Germany |
| München | 80336 | Germany |
| München | 81377 | Germany |
| München | 81675 | Germany |
| Trier | 54290 | Germany |
| Hong Kong | 852 | Hong Kong |
| Pokfulam | Hong Kong |
| Beersheba | 8410101 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91120 | Israel |
| Jerusalem | 9372212 | Israel |
| Kfar Saba | 4428164 | Israel |
| Rehovot | 7610001 | Israel |
| Tel Aviv | 6423906 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Ẕerifin | 70300 | Israel |
| Naples | Campania | 80131 | Italy |
| Meldola | Emilia-Romagna | 47014 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20141 | Italy |
| Monza | Lombardy | 20900 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Prato | Tuscany | 59100 | Italy |
| Terni | Umbria | 05100 | Italy |
| George Town | 10050 | Malaysia |
| George Town | 10400 | Malaysia |
| Kuala Lumpur | 56000 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Tanjung Bungah | 11200 | Malaysia |
| León | 37000 | Mexico |
| Christchurch | New Zealand |
| Hamilton | 3240 | New Zealand |
| Wellington | 0621 | New Zealand |
| Lima | 11 | Peru |
| Lima | 34 | Peru |
| Lima | Lima 27 | Peru |
| Chelyabinsk | 454087 | Russia |
| Kazan' | 420029 | Russia |
| Moscow | 115478 | Russia |
| Voronezh | 394000 | Russia |
| Singapore | 119074 | Singapore |
| Seoul | 138-736 | South Korea |
| Barcelona | Barcelona | 08035 | Spain |
| Lleida | Lerida | 25198 | Spain |
| Valencia | Valencia | 46015 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Patumwan | 10330 | Thailand |
| Songkhla | 90110 | Thailand |
| Brighton | BN1 9PX | United Kingdom |
| Cardiff | CF14 2TL | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| London | W1G 6AD | United Kingdom |
| Stoke-on-Trent | ST4 7LN | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
| C569670 | 1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided