What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as tamoxifen and aromatase inhibitors, have a range of side effects. Tamoxifen, a selective estrogen receptor modulator, often causes hot flushes, vaginal discharge, and a slight increase in thromboembolic events. Aromatase inhibitors, used in postmenopausal women, can lead to loss of bone density, fractures, and cardiovascular risks. Both treatments aim to manage hormone receptor-positive breast cancer but come with their own profiles of adverse effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer, particularly focusing on endocrine therapies for hormone receptor-positive breast cancer. Fulvestrant (Faslodex) is a well-known selective estrogen receptor degrader (SERD) that has been approved for use in postmenopausal women with hormone receptor-positive metastatic breast cancer. Additionally, aromatase inhibitors like letrozole (Femara) and anastrozole (Arimidex) are commonly used in this setting. Other notable FDA-approved treatments include tamoxifen, a selective estrogen receptor modulator (SERM), and CDK4/6 inhibitors like palbociclib (Ibrance) and ribociclib (Kisqali), which are often used in combination with endocrine therapies.

What other types of research exist?

Promising novel alternatives to OP-1250 for breast cancer patients in 2024 include: 1) Elacestrant (a SERD) which has shown efficacy in clinical trials for ER-positive, HER2-negative breast cancer. 2) Ribociclib and Alpelisib, which are being studied in combination with other agents for their potential benefits in hormone receptor-positive breast cancer. 3) Newer nonhormonal agents and PARP inhibitors like Olaparib and Rucaparib, especially for patients with BRCA mutations. These alternatives offer targeted approaches with varying mechanisms of action and are in different stages of clinical development and approval.

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PI3K Inhibitor

Combo Therapy for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Olema Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, OP-1250, combined with either ribociclib or alpelisib in cancer patients. It aims to see if these combinations are safe and can better stop cancer growth.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic HR+/HER2- breast cancer, who've had no more than one prior chemo and up to two hormone therapies. They should have a life expectancy of at least 6 months and be able to follow the study plan. Exclusions include other cancers, heart disease, liver disease not in early stages, recent serious blood clots or stroke, lung conditions like pneumonitis, or HIV.

What is being tested?

The study tests OP-1250 combined with either ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2). It's an open-label Phase 1b trial meaning both researchers and participants know which treatment is given. The goal is to assess safety and effectiveness of these combinations in treating breast cancer.

What are the potential side effects?

Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Liver function issues could occur due to oral medication absorption. Heart rhythm abnormalities are also possible along with general discomfort from taking the medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 when administered with ribociclib, alpelisib, or everolimus

Dose Limiting Toxicities (DLTs)

Pharmacokinetics (PK) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), or everolimus (Treatment Group 3).

Secondary study objectives

Evaluate clinical benefit rate (CBR) of OP-1250 when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3)

Evaluate duration of response (DoR) of OP-1250 when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3)

Preliminarily assess the anti-tumor activity (ORR) of OP-1250 when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), as assessed by the investigator using RECIST v1.1.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: OP-1250 with RibociclibExperimental Treatment2 Interventions

Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).

Group II: OP-1250 with EverolimusExperimental Treatment2 Interventions

Treatment Group 3: OP-1250 in combination with everolimus

Group III: OP-1250 with AlpelisibExperimental Treatment2 Interventions

Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

2010

Completed Phase 4

~1510

Alpelisib

2018

Completed Phase 3

~960

Ribociclib

2018

Completed Phase 3

~2420

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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 hormone receptor pathways, crucial for hormone receptor-positive breast cancers. Selective Estrogen Receptor Degraders (SERDs) like OP-1250 work by binding to estrogen receptors, leading to their degradation and preventing estrogen from promoting cancer cell growth. Aromatase inhibitors, another common treatment, reduce estrogen production, thereby limiting the hormone's availability to cancer cells. Chemotherapy, used for more aggressive or resistant cancers, kills rapidly dividing cells, including cancer cells. Understanding these mechanisms helps tailor treatments to individual patients, improving efficacy and minimizing side effects.

Overcoming recurrence risk: extended adjuvant endocrine therapy.