OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

September 30, 2027

Conditions
Breast CancerAdvanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma
Interventions
DRUG

Palazestrant

Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.

DRUG

Fulvestrant

Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle

DRUG

Anastrozole

Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle

DRUG

Letrozole

Participants will be treated with letrozole once daily on a 4 week (28 day) cycle

DRUG

Exemestane

Participants will be treated with exemestane once daily on a 4 week (28 day) cycle

Trial Locations (193)

100

RECRUITING

Clinical Trial Site, Taipei

111

RECRUITING

Clinical Trial Site, Taipei

114

RECRUITING

Clinical Trial Site, Taipei

433

RECRUITING

Clinical Trial Site, Taichung

500

RECRUITING

Clinical Trial Site, Changhua

736

RECRUITING

Clinical Trial Site, Tainan City

1200

RECRUITING

Clinical Trial Site, Woluwe-Saint-Lambert

1407

RECRUITING

Clinical Trial Site, Sofia

2145

RECRUITING

Clinical Trial Site, Westmead

2250

RECRUITING

Clinical Trial Site, Gosford

2650

RECRUITING

Clinical Trial Site, Edegem

2841

RECRUITING

Clinical Trial Site, Seoul

3000

RECRUITING

Clinical Trial Site, Vratsa

3080

RECRUITING

Clinical Trial Site, Seoul

3168

RECRUITING

Clinical Trial Site, Clayton

3355

RECRUITING

Clinical Trial Site, Ballarat Central

3630

RECRUITING

Clinical Trial Site, Shepparton

3722

RECRUITING

Clinical Trial Site, Seoul

4000

RECRUITING

Clinical Trial Site, San Miguel de Tucumán

4032

RECRUITING

Clinical Trial Site, Debrecen

4500

RECRUITING

Clinical Trial Site, Panagyurishte

4600

RECRUITING

Clinical Trial Site, San Salvador de Jujuy

5000

RECRUITING

Clinical Trial Site, Adelaide

5300

RECRUITING

Clinical Trial Site, La Rioja

5505

RECRUITING

Clinical Trial Site, Seoul

6000

RECRUITING

Clinical Trial Site, Charleroi

RECRUITING

Clinical Trial Site, Kecskemét

6009

RECRUITING

Clinical Trial Site, Nedlands

6273

RECRUITING

Clinical Trial Site, Seoul

6591

RECRUITING

Clinical Trial Site, Seoul

7624

RECRUITING

Clinical Trial Site, Pécs

8000

RECRUITING

Clinical Trials Site, Sungai Petani

8308

RECRUITING

Clinical Trial Site, Seoul

10032

RECRUITING

Clinical Trial Site, New York

10300

RECRUITING

Clinical Trial Site, Bangkok

10330

RECRUITING

Clinical Trial Site, Bangkok

10450

RECRUITING

Clinical Trial Site, George Town

10700

RECRUITING

Clinical Trial Site, Bangkok

11217

RECRUITING

Clinical Trial Site, Taipei

11776

RECRUITING

Clinical Trial Site, Port Jefferson Station

15121

RECRUITING

Clinical Trial Site, Alessandria

15706

RECRUITING

Clinical Trial Site, Santiago de Compostela

16150

RECRUITING

Clinical Trial Site, Kota Bharu

16247

RECRUITING

Clinical Trial Site, Suwon

16499

RECRUITING

Clinical Trial Site, Suwon

17007

RECRUITING

Clinical Trial Site, Girona

18840

RECRUITING

Clinical Trial Site, Sayre

19713

RECRUITING

Clinical Trial Site, Newark

20089

RECRUITING

Clinical Trial Site, Rozzano

20141

RECRUITING

Clinical Trial Site, Milan

21201

RECRUITING

Clinical Trial Site, Baltimore

24071

RECRUITING

Clinical Trial Site, León

24105

RECRUITING

Clinical Trial Site, Kiel

25030

RECRUITING

Clinical Trial Site, Besançon

25198

RECRUITING

Clinical Trial Site, Lleida

27100

RECRUITING

Clinical Trial Site, Pavia

28033

RECRUITING

Clinical Trial Site, Madrid

28050

RECRUITING

Clinical Trial Site, Madrid

30322

RECRUITING

Clinical Trial Site, Atlanta

30450

RECRUITING

Clinical Trial Site, Ipoh

31008

RECRUITING

Clinical Trial Site, Pamplona

32223

RECRUITING

Clinical Trials Site, Jacksonville

32804

RECRUITING

Clinical Trial Site, Orlando

33063

RECRUITING

Clinical Trial Site, Margate

33100

RECRUITING

Clinical Trial Site, Udine

33321

RECRUITING

Clinical Trial Site, Tamarac

33324

RECRUITING

Clinical Trial Site, Plantation

34070

RECRUITING

Clinical Trial Site, Montpellier

37203

RECRUITING

Clinical Trial Site, Nashville

37208

RECRUITING

Clinical Trial Site, Nashville

40138

RECRUITING

Clinical Trial Site, Bologna

40447

RECRUITING

Clinical Trial Site, Taichung

41009

RECRUITING

Clinical Trial Site, Seville

41124

RECRUITING

Clinical Trial Site, Modena

42100

RECRUITING

Clinical Trial Site, Reggio Emilia

42551

RECRUITING

Clinical Trial Site, Velbert

43623

RECRUITING

Clinical Trial Site, Toledo

44805

RECRUITING

Clinical Trial Site, Nantes

45070

RECRUITING

Clinical Trial Site, Zapopan

45409

RECRUITING

Clinical Trial Site, Dayton

46010

RECRUITING

Clinical Trial Site, Valencia

46050

RECRUITING

Clinical Trial Site, Petaling Jaya

47014

RECRUITING

Clinical Trial Site, Meldola

47805

RECRUITING

Clinical Trial Site, Krefeld

48202

RECRUITING

Clinical Trial Site, Detroit

49201

RECRUITING

Clinical Trial Site, Busan

50180

RECRUITING

Clinical Trial Site, Chiang Mai

55426

RECRUITING

Clinical Trial Site, Saint Louis Park

59100

RECRUITING

Clinical Trial Site, Kuala Lumpur

60200

RECRUITING

Clinical Trial Site, Compiègne

60637

RECRUITING

Clinical Trial Site, Chicago

61801

RECRUITING

Clinical Trial Site, Urbana

62250

RECRUITING

Clinical Trial Site, Putrajaya

63011

RECRUITING

Clinical Trial Site, Clermont-Ferrand

64116

RECRUITING

Clinical Trial Site, Monterrey

68020

RECRUITING

Clinical Trial Site, Oaxaca City

70112

RECRUITING

Clinical Trial Site, New Orleans

70809

RECRUITING

Clinical Trial Site, Baton Rouge

72015

RECRUITING

Clinical Trial Site, Le Mans

74120

RECRUITING

Clinical Trial Site, Samut Sakhon

75246

RECRUITING

Clinical Trial Site, Dallas

75390

RECRUITING

Clinical Trial Site, Dallas

76135

RECRUITING

Clinical Trial Site, Karlsruhe

77030

RECRUITING

Clinical Trial Site, Houston

80045

RECRUITING

Clinical Trial Site, Aurora

80218

RECRUITING

Clinical Trial Site, Denver

80230

RECRUITING

Clinical Trial Site, Sinaloa

80401

RECRUITING

Clinical Trial Site, Golden

80756

RECRUITING

Clinical Trial Site, Kaohsiung City

81505

RECRUITING

Clinical Trial Site, Grand Junction

83100

RECRUITING

Clinical Trial Site, Avellino

84405

RECRUITING

Clinical Trial Site, Ogden

85724

RECRUITING

Clinical Trial Site, Tucson

87401

RECRUITING

Clinical Trial Site, Farmington

90027

RECRUITING

Clinical Trial Site, Los Angeles

90110

RECRUITING

Clinical Trial Site, Songkhla

90602

RECRUITING

Clinical Trial Site, Whittier

92093

RECRUITING

Clinical Trial Site, La Jolla

92708

RECRUITING

Clinical Trial Site, Fountain Valley

93586

RECRUITING

Clinical Trial Site, Kuching

94085

RECRUITING

Clinical Trial Site, Villejuif

97239

RECRUITING

Clinical Trial Site, Portland

99204

RECRUITING

Clinical Trial Site, Spokane

99218

RECRUITING

Clinical Trial Site, Spokane

100176

RECRUITING

Clinical Trial Site, Central

200385

RECRUITING

Clinical Trial Site, Craiova

300239

RECRUITING

Clinical Trial Site, Timișoara

400015

RECRUITING

Clinical Trial Site, Cluj-Napoca

410469

RECRUITING

Clinical Trial Site, Oradea

500152

RECRUITING

Clinical Trial Site, Brasov

700106

RECRUITING

Clinical Trial Site, Iași

999077

RECRUITING

Clinical Trial Site, Central

RECRUITING

Clinical Trial Site, Kowloon

RECRUITING

Clinical Trial Site, Hong Kong

RECRUITING

Clinical Trials Site, Hong Kong

06810

RECRUITING

Clinical Trial Site, Danbury

60616-2315

RECRUITING

Clinical Trial Site, Chicago

02111

RECRUITING

Clinical Trial Site, Boston

68510-2496

RECRUITING

Clinical Trial Site, Lincoln

B8000HXM

RECRUITING

Clinical Trial Site, Bahía Blanca

B7600FZN

RECRUITING

Clinical Trial Site, Mar del Plata

Unknown

RECRUITING

Clinical Trial Site, Mar del Plata

RECRUITING

Clinical Trial Site, Leuven

X5000HHW

RECRUITING

Clinical Trial Site, Córdoba

X5008HHW

RECRUITING

Clinical Trial Site, Córdoba

R8500ACE

RECRUITING

Clinical Trial Site, Viedma

S2013DTC

RECRUITING

Clinical Trial Site, Rosario

S2013KDS

RECRUITING

Clinical Trial Site, Rosario

C14626ABP

ACTIVE_NOT_RECRUITING

Clinical Trial Site, Buenos Aires

40050-410

RECRUITING

Clinical Trial Site, Salvador

30150-221

RECRUITING

Clinical Trial Site, Belo Horizonte

50070-480

RECRUITING

Clinical Trial Site, Recife

90035-903

RECRUITING

Clinical Trial Site, Porto Alegre

90050-170

RECRUITING

Clinical Trial Site, Porto Alegre

88301-220

RECRUITING

Clinical Trial Site, Itajaí

18060-105

RECRUITING

Clinical Trial Site, Sorocaba

20560-120

RECRUITING

Clinical Trial Site, Rio de Janeiro

T2N 4N2

RECRUITING

Clinical Trial Site, Calgary

N6A 5W9

RECRUITING

Clinical Trial Site, London

M5G 1X5

RECRUITING

Clinical Trial Site, Toronto

H4A 3J1

RECRUITING

Clinical Trial Site, Montreal

500 12

RECRUITING

Clinical Trial Site, Hradec Králové

741 01

RECRUITING

Clinical Trial Site, Nový Jičín

799 00

RECRUITING

Clinical Trial Site, Olomouc

01012

RECRUITING

Clinical Trial Site, Bourg-en-Bresse

01307

RECRUITING

Clinical Trial Site, Dresden

00144

RECRUITING

Clinical Trial Site, Rome

00168

RECRUITING

Clinical Trial Site, Rome

1081 HV

RECRUITING

Clinical Trial Site, Amsterdam

3083 AN

RECRUITING

Clinical Trial Site, Rotterdam

60-185

RECRUITING

Clinical Trial Site, Skórzewo

20-818

RECRUITING

Clinical Trial Site, Lublin

90-349

RECRUITING

Clinical Trial Site, Lodz

05-400

RECRUITING

Clinical Trial Site, Otwock

36-200

RECRUITING

Clinical Trial Site, Brzozów

35-922

RECRUITING

Clinical Trial Site, Rzeszów

81-519

RECRUITING

Clinical Trial Site, Gdynia

31-501

RECRUITING

Clinical Trial Site, Krakow

50-450

RECRUITING

Clinical Trial Site, Wroclaw

3000-075

RECRUITING

Clinical Trial Site, Coimbra

1099-023

RECRUITING

Clinical Trial Site, Lisbon

1500-473

RECRUITING

Clinical Trial Site, Lisbon

4454-509

RECRUITING

Clinical Trial Site, Matosinhos Municipality

4050-428

RECRUITING

Clinical Trial Site, Porto

00682-6391

RECRUITING

Clinical Trial Site, Mayagüez

014141

RECRUITING

Clinical Trial Site, Bucharest

06080

RECRUITING

Clinical Trial Site, Badajoz

03015

RECRUITING

Clinical Trial Site, Alicante

LE5 4PW

RECRUITING

Clinical Trial Site, Leicester

NG5 1PB

RECRUITING

Clinical Trial Site, Nottingham

TA1 5DA

RECRUITING

Clinical Trial Site, Taunton

LL18 5UJ

RECRUITING

Clinical Trial Site, Bodelwyddan

EC1M 6BQ

RECRUITING

Clinical Trial Site, London

Sponsors
All Listed Sponsors
lead

Olema Pharmaceuticals, Inc.

INDUSTRY