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

PHASE2CompletedINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Breast Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (130)

11

Lima

34

Lima

852

Hong Kong

1000

Brussels

1025

Buenos Aires

1070

Brussels

2076

Wahroonga

2100

København Ø

2217

Kogarah

2650

Edegem

2730

Herlev

3000

Leuven

3050

Parkville

3199

Frankston

3240

Hamilton

4000

Liège

Roskilde

4101

South Brisbane

5000

Odense

5011

Woodville

5042

Bedford Park

7100

Vejle

8000

Aarhus

10050

George Town

10065

New York

10330

Patumwan

10400

George Town

10591

Sleepy Hollow

11200

Tanjung Bungah

11570

Rockville Centre

11725

Commack

13125

Berlin

19104

Philadelphia

20010

Washington D.C.

20121

Milan

20132

Milan

20141

Milan

20246

Hamburg

20900

Monza

23226

Richmond

25198

Lleida

29425

Charleston

30060

Marietta

32224

Jacksonville

33428

Boca Raton

33705

St. Petersburg

33916

Fort Myers

35294

Birmingham

37000

León

37211

Nashville

37232

Nashville

37404

Chattanooga

38138

Germantown

40225

Düsseldorf

46015

Valencia

47014

Meldola

50009

Zaragoza

52621

Tel Litwinsky

54290

Trier

56000

Kuala Lumpur

56100

Pisa

58100

Holon

59100

Prato

Kuala Lumpur

60435

Joliet

61615

Peoria

63128

St Louis

70300

Ẕerifin

75231

Paris

75246

Dallas

75702

Tyler

76104

Fort Worth

77030

Houston

79106

Freiburg im Breisgau

79110

Freiburg im Breisgau

80131

Napoli

80336

München

81377

München

81675

München

90110

Songkhla

91120

Jerusalem

94080

South San Francisco

94115

San Francisco

94545

Hayward

94589

Vallejo

94596

Walnut Creek

94611

Oakland

95051

Santa Clara

95119

San Jose

95661

Roseville

95825

Sacramento

115478

Moscow

119074

Singapore

394000

Voronezh

420029

Kazan'

454087

Chelyabinsk

2341391

Valparaíso

2540364

Viña del Mar

4428164

Kfar Saba

4810469

Temuco

6423906

Tel Aviv

7610001

Rehovot

7630370

Santiago

8410101

Beersheba

9372212

Jerusalem

67214-3728

Wichita

02115

Boston

02215

Boston

07920

Basking Ridge

07601

Hackensack

77030-4095

Houston

03000

Santa Fe

H3G 1A4

Montreal

G1R 2J6

Québec

S7N 4H4

Saskatoon

656 53

Brno

775 20

Olomouc

128 08

Prague

Unknown

Pokfulam

Christchurch

05100

Terni

0621

Wellington

Lima 27

Lima

138-736

Seoul

08035

Barcelona

BN1 9PX

Brighton

CF14 2TL

Cardiff

SW3 6JJ

London

W1G 6AD

London

ST4 7LN

Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT01437566 - Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy | Biotech Hunter | Biotech Hunter