Is NCT05508906 recruiting in Gilbert, AZ?

Yes, NCT05508906 is currently recruiting participants at its Gilbert, AZ location. This metastatic breast cancer clinical trial is actively enrolling qualified participants.

How do I join the metastatic breast cancer clinical trial in Gilbert?

To join this clinical trial in Gilbert, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Gilbert clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Breast Cancer Clinical Trial in Gilbert, AZ

About This Metastatic Breast Cancer Study in Gilbert

This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation). Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus. Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.

Sponsor: Olema Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

Female or male aged \>18 years.

Willing and able to participate and comply with all study requirements.

Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).

ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.

Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.

Life expectancy ≥6 months, as judged by the investigator.

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

Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.

Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.

Exclusion Criteria

Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.

Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.

History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.

History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.

History of pneumonitis or interstitial lung disease.

Leptomeningeal disease or spinal cord compression.

Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.

Known human immunodeficiency virus infection.

Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.

History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.

Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).

Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.

Have received prior treatment with OP-1250.

Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gilbert?

Yes, this clinical trial (NCT05508906) has an active research site in Gilbert, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Breast Cancer Treatment Options in Gilbert, AZ

If you're searching for metastatic breast cancer treatment options in Gilbert, AZ, this clinical trial (NCT05508906) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gilbert research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic breast cancer clinical trials near you to find additional studies recruiting in your area.

Metastatic Breast Cancer Clinical Trial in Gilbert, AZ

Expert Care in Gilbert

IRB Approved

No-Cost Care

Apply for This Gilbert Location

Why Participate?

Simple Process