Actively Recruiting
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Led by Olema Pharmaceuticals, Inc. · Updated on 2026-04-16
1000
Participants Needed
85
Research Sites
321 weeks
Total Duration
On this page
Sponsors
O
Olema Pharmaceuticals, Inc.
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
CONDITIONS
Official Title
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer not suitable for curative therapy.
- Measurable disease per RECIST 1.1 or bone-only disease.
- New advanced breast cancer or recurrence after 12 months of completing adjuvant endocrine therapy.
- ECOG performance status of 0 or 1.
- Adequate blood, liver, and kidney function.
- Female participants can be pre-, peri-, or postmenopausal.
- Male and pre- or peri-menopausal female participants must agree to take a GnRH or LHRH agonist.
You will not qualify if you...
- Disease recurrence during adjuvant endocrine therapy.
- Currently receiving or previously received systemic anti-cancer therapy for advanced ER+, HER2- breast cancer.
- Previous treatment with fulvestrant, elacestrant, or investigational endocrine therapy.
- History of allergic reactions to study drugs.
- Contraindications to letrozole or ribociclib.
- Symptomatic brain metastases, carcinomatous meningitis, leptomeningeal disease, or spinal cord compression requiring immediate treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 85 locations
1
Clinical Trial Site
Hot Springs, Arkansas, United States, 71913
Active, Not Recruiting
2
Clinical Trial Site
Santa Barbara, California, United States, 93105
Active, Not Recruiting
3
Clinical Trial Site
Denver, Colorado, United States, 80220
Actively Recruiting
4
Clinical Trial Site
Peoria, Illinois, United States, 61615
Active, Not Recruiting
5
Clinical Trial Site
Ames, Iowa, United States, 50010
Active, Not Recruiting
6
Clinical Trial Site
Scarborough, Maine, United States, 04074
Actively Recruiting
7
Clinical Trial Site
Annapolis, Maryland, United States, 21401
Active, Not Recruiting
8
Clinical Trial Site
Kansas City, Missouri, United States, 64132
Actively Recruiting
9
Clinical Trial Site
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
10
Clinical Trial Site
Columbus, Ohio, United States, 43219
Actively Recruiting
11
Clinical Trial Site
Horsham, Pennsylvania, United States, 19044
Active, Not Recruiting
12
Clinical Trial Site
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
13
Clinical Trial Site
Knoxville, Tennessee, United States, 37909
Active, Not Recruiting
14
Clinical Trial Site
Tennessee City, Tennessee, United States, 37203
Active, Not Recruiting
15
Clinical Trial Site
Denton, Texas, United States, 76201
Active, Not Recruiting
16
Clinical Trial Site
El Paso, Texas, United States, 79902
Active, Not Recruiting
17
Clinical Trial Site
Houston, Texas, United States, 77024
Active, Not Recruiting
18
Clinical Trial Site
San Antonio, Texas, United States, 78229
Active, Not Recruiting
19
Clinical Trial Site
Salt Lake City, Utah, United States, 84106
Not Yet Recruiting
20
Clinical Trial Site
Olympia, Washington, United States, 98502
Active, Not Recruiting
21
Clinical Trial Site
Vancouver, Washington, United States, 98684
Active, Not Recruiting
22
Clinical Trial Site
Sydney, New South Wales, Australia, 2109
Actively Recruiting
23
Clinical Trial Site
Waratah, New South Wales, Australia, 2298
Actively Recruiting
24
Clinical Trial Site
South Brisbane, Queensland, Australia, 4101
Active, Not Recruiting
25
Clinical Trial Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
26
Clinical Trial Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
27
Clinical Trial Site
Geelong, Victoria, Australia, 3220
Actively Recruiting
28
Clinical Trial Site
Heidelberg, Victoria, Australia, 03084
Actively Recruiting
29
Clinical Trial Site
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
30
Clinical Trial Site
Toronto, Ontario, Canada, M2J 1V1
Actively Recruiting
31
Clinical Trial Site
Bobigny, France, 93000
Active, Not Recruiting
32
Clinical Trial Site
Athens, Pireas, Greece, 18547
Active, Not Recruiting
33
Clinical Trial Site
Thessaloniki, Thessaloniki, Greece, 57001
Active, Not Recruiting
34
Clinical Trial Site
Hong Kong, Hong Kong, Hong Kong, 999077
Active, Not Recruiting
35
Clinical Trial Site
Hong Kong, Kowloon, Hong Kong, 999077
Actively Recruiting
36
Clinical Trial Site
Hong Kong, Pok Fu Lam, Hong Kong, 999077
Actively Recruiting
37
Clinical Trial Site
Milan, Milano, Italy, 20132
Active, Not Recruiting
38
Clinical Trial Site
Ipoh, Ipoh Perak, Malaysia, 30450
Active, Not Recruiting
39
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
Active, Not Recruiting
40
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
Active, Not Recruiting
41
Clinical Trial Site
George Town, Pulau Pinang, Malaysia, 10450
Actively Recruiting
42
Clinical Trial Site
Kota Kinabalu, Sabah, Malaysia, 88996
Actively Recruiting
43
Clinical Trial Site
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
44
Clinical Trial Site
Petaling Jaya, Selangor, Malaysia, 46050
Active, Not Recruiting
45
Clinical Trial Site
Putrajaya, Wilayah PE, Malaysia, 62250
Actively Recruiting
46
Clinical Trial Site
Apeldoorn, Gelderland, Netherlands, 7334 DZ
Active, Not Recruiting
47
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
Active, Not Recruiting
48
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, Poland, 35-922
Active, Not Recruiting
49
Clinical Trial Site
Brzozów, Woj Podkarpackie, Poland, 36-200
Active, Not Recruiting
50
Clinical Trial Site
Cluj-Napoca, Cluj, Romania, 400641
Actively Recruiting
51
Clinical Trial Site
Iași, Iaşi, Romania, 700106
Active, Not Recruiting
52
Clinical Trial Site
Timișoara, Timiș County, Romania, 300239
Active, Not Recruiting
53
Clinical Trial Site
Busan, Busan Metropolitan City, South Korea, 49201
Active, Not Recruiting
54
Clinical Trial Site
Daegu, Daegu Metropolitan City, South Korea, 41404
Active, Not Recruiting
55
Clinical Trial Site
Goyang-si, Gyeonggi-do, South Korea, 10408
Active, Not Recruiting
56
Clinical Trial Site
Seongnam-si, Gyeonggi-do, South Korea, 13620
Active, Not Recruiting
57
Clinical Trial Site
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
58
Clinical Trial Site
Yongin-si, Gyeonggi-do, South Korea, 16499
Active, Not Recruiting
59
Clinical Trial Site
Seoul, Seoul, South Korea, 02841
Active, Not Recruiting
60
Clinical Trial Site
Seoul, Seoul, South Korea, 03080
Actively Recruiting
61
Clinical Trial Site
Seoul, Seoul, South Korea, 03722
Active, Not Recruiting
62
Clinical Trial Site
Seoul, Seoul Special City, South Korea, 05505
Active, Not Recruiting
63
Clinical Trial Site
Seoul, Seoul Special City, South Korea, 08308
Active, Not Recruiting
64
Clinical Trial Site
Alicante, Alicante, Spain, 3010
Active, Not Recruiting
65
Clinical Trial Site
Barcelona, Barcelona, Spain, 08028
Actively Recruiting
66
Clinical Trial Site
Barcelona, Barcelona, Spain, 08036
Active, Not Recruiting
67
Clinical Trial Site
Granada, Granada, Spain, 18012
Active, Not Recruiting
68
Clinical Trial Site
Madrid, Madrid, Spain, 28040
Actively Recruiting
69
Clinical Trial Site
Murcia, Murcia, Spain, 30120
Active, Not Recruiting
70
Clinical Trial Site
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
71
Clinical Trial Site
Chang-hua, Chang Hua, Taiwan, 50006
Active, Not Recruiting
72
Clinical Trial Site
Kaohsiung City, Sanmin, Taiwan, 80756
Actively Recruiting
73
Clinical Trial Site
Taipei, Special Municipality, Taiwan, 11217
Actively Recruiting
74
Clinical Trial Site
Taipei, Special Municipality, Taiwan, 11490
Active, Not Recruiting
75
Clinical Trial Site
Taipei, Taipei City, Taiwan, 100
Active, Not Recruiting
76
Clinical Trial Site
Taipei, Taipei City, Taiwan, 10449
Active, Not Recruiting
77
Clinical Trial Site
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
78
Clinical Trial Site
Dusit, Bangkok, Thailand, 10300
Actively Recruiting
79
Clinical Trial Site
Ban Phaeo, Changwat Samut Sakhon, Thailand, 74120
Actively Recruiting
80
Clinical Trial Site
Hat Yai, Changwat Songkhla, Thailand, 90110
Actively Recruiting
81
Clinical Trial Site
Chiang Mai, Chiang Mai, Thailand, 50200
Actively Recruiting
82
Clinical Trial Site
Brighton, England, United Kingdom, BN2 5BE
Actively Recruiting
83
Clinical Trial Site
London, England, United Kingdom, WC1E 6AG
Active, Not Recruiting
84
Clinical Trial Site
London, Greater London, United Kingdom, EC1M 6BQ
Active, Not Recruiting
85
Clinical Trial Site
Guildford, Surrey, United Kingdom, GU2 7XX
Active, Not Recruiting
Research Team
O
Olema Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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