Is NCT06099769 recruiting in Basking Ridge, NJ?

Yes, NCT06099769 is currently recruiting participants at its Basking Ridge, NJ location. This metastatic breast cancer clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Basking Ridge, 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 Basking Ridge 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 Basking Ridge, NJ

About This Metastatic Breast Cancer Study in Basking Ridge

The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Screening Cohort (non-MSK patients only):

Age ≥18 years at time of consent

signed the pre-screening informed consent document to allow for AR testing as part of study screening Treatment Cohort:

Female or male

Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic

TNBC (ER/PgR \<1%) or ER-low defined as:

ER and PgR 1-10%

HER2 negative per American Society of Clinical Oncology/College of American Pathologists guidelines

Local testing for ER/PgR and HER2 is acceptable for eligibility.

Tumor must be AR positive. AR is considered positive by IHC if ≥10% of cell nuclei are immunoreactive. °AR testing performed locally must use protocol specified methodology to be acceptable for eligibility. Central testing is an option for those unable to perform local testing per this methodology. Please refer to the Section entitled "Treatment Plan" for AR testing methodology or refer to the laboratory manual.

Evaluable or measurable disease per RECIST version 1.1; subjects with no evaluable AND no measurable disease (e.g., malignant effusions or bone marrow as the only manifestations of disease) are not eligible for enrollment.

Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, paclitaxel, or carboplatin), as per investigator assessment.

A representative, formalin-fixed, paraffin-embedded tumor specimen that enables the diagnosis of breast cancer, with adequate viable tumor cells in a tissue block (preferred) or 15 freshly cut unstained slides and 1 H\&E slide. Tissue from a metastatic site is preferred. If not available, tissue from the primary site may be obtained.

Patients may have received up to 2 prior lines of chemotherapy for metastatic breast cancer.

Patients with ER-low breast cancer may receive any number of lines of endocrine therapy +/- targeted therapy (i.e., CDK4/6 inhibitors, PI3K inhibitors).

Patients with PD-L1 positive breast cancer (CPS ≥ 10) should have received prior treatment with a checkpoint inhibitor setting unless there is a contraindication to checkpoint inhibitor therapy.

Patients may receive bisphosphonate or denosumab.

ECOG performance status 0-2.

Age ≥18 years.

Able to understand and the willingness to provide informed consent.

Patients must not have another active malignancy that requires treatment.

Women of child-bearing potential and men must agree to use 2 forms of adequate contraception (i.e., barrier contraception, abstinence, intrauterine device, or sterilization method) during study period and for 7 months following treatment end. Women must not breast feed while on study and for at least 3 months after final drug administration.

Ability to swallow intact enzalutamide and mifepristone.

Patient must be recovered from any recent major surgery. Radiation must have completed 14 days prior to study start. If treated in the second-line setting, the last chemotherapy or investigational anticancer therapy dose must be at least 14 days prior.

Adequate organ and marrow function, as defined below:

ANC ≥1000, hemoglobin ≥9 g/dL, platelets ≥100,000

Total bilirubin ≤1.5x upper limit of normal (ULN), except for patients with known Gilbert syndrome; AST/ALT ≤3x ULN (≤5x ULN if liver metastases); creatinine ≤ 1.5x ULN.

Cortisol within normal limits

Patients must agree to research biopsy at study entry until 40 patients randomized to Arm A and 40 patients randomized to Arm B and 20 patients randomized to Arm C have been biopsied.

Biopsy requirement may be waived in consultation with the study PI (Drs. Traina or Nanda) if not medically feasible.

Exclusion Criteria

Seizure disorder or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months.

History of brain metastases or leptomeningeal disease.

Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors).

Other concurrent investigational anticancer agents.

Confirmed QT interval with Fridericia correction (QTcF) \> 480 msec.

Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or that interferes with the patient's ability to participate in the study requirements.

Pregnant patients are not eligible for study.

Women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma are excluded from study.

An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, uncontrolled celiac disease).

Use of concurrent or chronic daily corticosteroid use. Topical or inhaled corticosteroids are permitted.

Use of concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4. Patients may be switched to alternative medications for eligibility purposes. A list of CYP3A4 substrates, inducers, and/or inhibitors

Hypersensitivity reaction to the active pharmaceutical ingredient or any of the tablet components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.

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 Basking Ridge?

Yes, this clinical trial (NCT06099769) has an active research site in Basking Ridge, NJ 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 Basking Ridge, NJ

If you're searching for metastatic breast cancer treatment options in Basking Ridge, NJ, this clinical trial (NCT06099769) 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 Basking Ridge research site is actively enrolling participants for this phase 2 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 Basking Ridge, NJ

Expert Care in Basking Ridge

IRB Approved

No-Cost Care

Apply for This Basking Ridge Location

Why Participate?

Simple Process