What side effects are associated with this type of intervention?

Common treatments for hormone receptor-positive, HER2-negative breast cancer, such as tamoxifen and aromatase inhibitors, have several known side effects. Tamoxifen can cause hot flushes, vaginal discharge, and an increased risk of thromboembolic events and endometrial carcinoma. Aromatase inhibitors, like anastrozole, are associated with loss of bone density, fractures, and cardiovascular risks. These side effects are important considerations for patients undergoing endocrine therapy for breast cancer.

What prior FDA approvals exist?

The FDA has approved several treatments for hormone receptor-positive, HER2-negative breast cancer, which are similar to the investigational drug OP-1250, a Selective Estrogen Receptor Degrader (SERD). Notable FDA-approved SERDs include fulvestrant, which works by degrading estrogen receptors and is used in postmenopausal women with advanced breast cancer. Additionally, other endocrine therapies such as aromatase inhibitors (e.g., letrozole, anastrozole) and selective estrogen receptor modulators (SERMs) like tamoxifen have been approved for similar indications. These therapies aim to block or reduce the effects of estrogen on breast cancer cells, thereby inhibiting tumor growth.

What other types of research exist?

Promising alternatives to OP-1250 for breast cancer treatment in 2024 include other SERDs like elacestrant, which has shown efficacy in clinical trials. Additionally, oral aromatase inhibitors such as anastrozole and letrozole remain important options. PARP inhibitors like olaparib and rucaparib are also promising, especially for patients with BRCA mutations.

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Hormone Therapy

OP-1250 for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Olema Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Significant cardiovascular disease

Ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 days after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called OP-1250 in adults with a specific type of advanced breast cancer. The drug aims to block certain receptors on cancer cells to stop them from growing. The study will determine the best dose and check for any side effects.

Who is the study for?

This trial is for adults with advanced HR-positive, HER2-negative breast cancer who've had at least one hormonal treatment and six months of continuous endocrine therapy. Participants need good liver and kidney function, haven't had certain therapies recently, are not pregnant or breastfeeding, willing to use contraception, have a stable ECOG status (0 or 1), and no significant heart disease or infections.

What is being tested?

The study is testing different doses of OP-1250 to find the safest and most effective level for treating hormone receptor-positive, HER2-negative advanced breast cancer. It's an open-label trial meaning everyone knows what treatment they're getting.

What are the potential side effects?

While specific side effects aren't listed here, common ones in trials like this may include nausea, fatigue, headache, hot flashes related to hormonal changes; plus potential liver or kidney-related issues due to medication processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had hormone therapy for my advanced cancer for at least 6 months.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I am currently being treated for a serious infection.

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I have a serious kidney condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 days after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 42 days after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days after end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anti-tumor activity of OP-1250

Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250

Dose Limiting Toxicities (DLT)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: OP-1250 Phase IIExperimental Treatment1 Intervention

This portion of the study further explores the clinical activity, safety, and PK of OP-1250 monotherapy at the RP2D and will estimate preliminary anti-tumor efficacy in 3 cohorts. Cohort A will enroll subjects with measurable disease without evidence of CNS metastases; Cohort B will enroll subjects with non-measurable (evaluable) disease without evidence of CNS metastases; and Cohort C will enroll subjects with evaluable disease (measurable and non-measurable) with CNS metastases.

Group II: OP-1250 Phase I Part A (Dose Escalation) and Part B (Dose Expansion)Experimental Treatment1 Intervention

Phase I Part A will evaluate the safety and pharmacokinetics (PK)of a range of OP-1250 doses to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Phase I Part B will evaluate the safety and PK of OP-1250 to confirm the RP2D dose.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments often target specific mechanisms to inhibit tumor growth and progression. Endocrine therapies, such as Selective Estrogen Receptor Degraders (SERDs) like OP-1250, work by binding to estrogen receptors and promoting their degradation, thereby blocking the proliferative action of estrogen on hormone receptor-positive breast cancer cells. Aromatase inhibitors reduce estrogen production, while selective estrogen receptor modulators (SERMs) like tamoxifen block estrogen receptors. Chemotherapy targets rapidly dividing cells, including cancer cells, but can affect normal cells as well. Targeted therapies, such as HER2 inhibitors and CDK4/6 inhibitors, specifically target molecular pathways involved in cancer cell growth and survival. Understanding these mechanisms helps tailor treatments to individual patients, improving efficacy and minimizing side effects.

Overcoming recurrence risk: extended adjuvant endocrine therapy.