Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

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NCT07085767 · readout ≤ 865 d

Sponsored by Olema Pharmaceuticals, Inc. (industry) · OLMA — their whole pipeline →. With Novartis Pharmaceuticals.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Triple · Treatment

Enrollment

1,000estimated

Sites

181

Countries

Australia, Austria, Belgium +20

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-11-03

actual

When the study began enrolling

Primary completion

Dec 2028

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jan 2032

estimated

The whole study's end, after follow-up

First posted

2025-07-25

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-17

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Breast Cancer
Locally Advanced Breast Cancer
Metastatic Breast Cancer
ER Positive Breast Cancer
HER2 Negative Breast Carcinoma

Interventions

Drug: Palazestrant — also filed as OP-1250
Drug: Letrozole-matching placebo
Drug: Ribociclib
Drug: Letrozole
Drug: Palazestrant matching-placebo

Primary outcome

what the primary-completion date above is the date OF

Progression-Free Survival (PFS)

measured From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)

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