Is NCT05846789 recruiting in Indianapolis, IN?

Yes, NCT05846789 is currently recruiting participants at its Indianapolis, IN location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Indianapolis?

To join this clinical trial in Indianapolis, 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 Indianapolis 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.

Breast Cancer Clinical Trial in Indianapolis, IN

Who Can Participate

Inclusion Criteria

≥ 18 years old at the time of informed consent

Ability to provide written informed consent and HIPAA authorization

Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-positive (ER and PR ≤ 1% weak staining)

For patients with TNBC

Received up to 2 prior therapies for metastatic disease

Prior (neo)adjuvant chemotherapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of completion of (neo)adjuvant therapy.

Patients with TNBC whose tumors are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.

Patients who received (neo)adjuvant IO therapy and progress while on or within 12 months of completion of (neo)adjuvant IO therapy may participate without additional IO treatment.

Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting.

PD-L1 status is not required for patients beyond the first line setting.

Participation in this protocol as either first, second and third-line therapy is allowed

For patients with ER- positive, HER2-negative breast cancer

Must have received prior hormone therapy + CDKi in the adjuvant or metastatic setting. There is no limit on the number of prior hormone therapy regimens.

May have received up to 3 prior chemotherapies for metastatic disease.

Prior (neo)adjuvant chemotherapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of completion of (neo)adjuvant therapy.

Participation in this protocol as either first, second, third, or fourth-line therapy is allowed

Planned standard of care chemotherapy based on NCCN guidelines.

Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.

Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other chemotherapy agents.

Measurable disease based on RECIST 1.1 criteria.

ECOG PS 0 or 1

Patients with treated, asymptomatic CNS disease may participate if the patient is \> 4 weeks from completion of CNS therapy (radiation and/or surgery), is clinically stable at the time of study entry, and is receiving stable or decreasing dose of corticosteroids. Brain MRI or head CT is required at screening for patients with known brain metastases.

Adequate organ function as indicated by:

Total bilirubin \< ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL)

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 x ULN

Creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula

Absolute neutrophil count (ANC) \> 1.2 K/mm3

Platelets \> 75 K/ mm3

Hgb \> 9.0 g/dL

Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:

Has undergone a hysterectomy or bilateral oophorectomy; or

Has been naturally amenorrheic for at least 24 consecutive months.

Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment. NOTE: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).

Exclusion Criteria

Prior treatment with or known contraindication to treatment with tocilizumab biosimilar or other IL-6/IL-6R targeted agent

Active infection requiring parenteral antibiotics

Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement

Active or symptomatic CNS disease

Patients with HER2+ disease Note: HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \> 2.0 or \> 6 total HER2 gene copies per cell.

Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded

Radiation therapy within 2 weeks of registration

Hormone therapy within 2 weeks of registration

Planned treatment with Olaparib or other PARP inhibitor.

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 Indianapolis?

Yes, this clinical trial (NCT05846789) has an active research site in Indianapolis, IN 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.

Breast Cancer Treatment Options in Indianapolis, IN

If you're searching for breast cancer treatment options in Indianapolis, IN, this clinical trial (NCT05846789) 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 Indianapolis research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced 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 breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Indianapolis, IN

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About This Breast Cancer Study in Indianapolis