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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Palazestrant — DRUG
  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.
• Fulvestrant — DRUG
  Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
• Anastrozole — DRUG
  Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
• Letrozole — DRUG
  Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
• Exemestane — DRUG
  Participants will be treated with exemestane once daily on a 4 week (28 day) cycle

Study Details

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Key Dates

Start date

Nov 16, 2023

Status verified

Aug 2025

Primary completion

Jun 30, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

510 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Palazestrant (OP-1250)
  Participants will receive Palazestrant
• Active Comparator: Standard of Care Endocrine Therapy
  Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

Primary Outcome Measure

Dose-Selection Part: Incidence of adverse events [ Time Frame: From Date of Randomization up to 16 weeks ]

Central Contacts

• Olema Pharmaceuticals, Inc.
  415-651-7206
  [email protected]

Locations (47)

Find similar trials in Tucson, AZ

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