Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Recruiting
Phase 3
Interventional Study
Breast Cancer
Locally Advanced Breast Cancer
Metastatic Breast Cancer
ER Positive Breast Cancer
HER2 Negative Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,000 (estimated)
- Sponsor
- Olema Pharmaceuticals, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult female or male participants.
* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
* De novo advanced breast cancer or with disease recurrence occu…
Contacts