Is NCT06085742 recruiting in Chicago, IL?

Yes, NCT06085742 is currently recruiting participants at its Chicago, IL location. This breast cancer clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Chicago, 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 Chicago 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 Chicago, IL

Who Can Participate

Inclusion Criteria

I• Age ≥ 18 years of age at time of consent

ECOG performance status 0, 1, or 2

Histologically confirmed invasive breast cancer documented by biopsy or surgical excision.

Underwent potentially curative resection of primary breast tumor(s) with no gross residual local-regional disease (patients with microscopically positive margins are eligible if adjuvant radiotherapy is planned), with most recent breast or axillary surgery \< 90 days prior to date of signed consent.

No evidence of distant metastatic disease

No prior systemic therapy for this cancer other than pre-operative endocrine therapy

Treating Oncologist recommends adjuvant chemotherapy without concurrent biologic/targeted therapy. Patients may receive a CDK4/6 inhibitor after completion of all study treatment, concurrently with adjuvant endocrine therapy. Patients with a germline pathogenic/likely pathogenic variant in a DNA homologous repair gene (e.g. BRCA1, BRCA2, PALB2) may receive adjuvant PARP inhibitor therapy after completion of all study treatment.

Tumor is estrogen receptor (ER)-positive (\> 10% by IHC) and/or progesterone receptor (PR)-positive (\> 10% by IHC), HER2-negative by IHC or FISH according to 2018 ASCO-CAP guidelines.

AJCC pathologic stage: o pT1-3/pN0-2 based on sentinel lymph node biopsy or axillary dissection

High risk gene expression profile (either luminal B on MammaPrint/BluePrint, or Recurrence Score \> 25 on Oncotype Dx). Study participants are not required to have a high-risk gene expression profile if they have a clinical high-risk tumor, defined as: Age \< 50 and any of the following:

Involvement of 1-3 axillary lymph nodes with metastatic carcinoma (pN1mic/N1)

grade 1 tumor \> 3 cm; or grade 2 tumor \> 2 cm; or grade 3 tumors \> 1 cm (size based on pathological assessment of the maximal dimension of the invasive component of the tumor)

pT1c-T2 and Ki-67 \> 20%

Presence of lymphovascular invasion stage IIIA (pT3/pN1 or pT1-3/pN2) Age \> 50 and any of the following:

Primary tumor \> 5 cm (pT3)

stage IIIA (pT3/pN1 or pT1-3/pN2)

Adequate organ function as defined in Table 1. All screening labs to be obtained within 30 days prior to registration.

Patients with synchronous bilateral primary breast tumors or multiple ipsilateral primary breast tumors are eligible if the treating Oncologist determines that the CMC regimen is appropriate therapy for all primary tumors requiring chemotherapy.

Able to provide written informed consent and HIPAA authorization for release of personal health information.

Women of childbearing potential must agree to use 2 methods of birth control, at least one being a barrier form of contraception if they are sexually active with a male partner unless they are considered highly unlikely to conceive as defined in section 8.6, and cannot be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.

As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Patients with history of HIV/AIDS (acquired immunodeficiency syndrome) are eligible for this study if they are receiving anti-retroviral therapy and it does not include any medications known to alter metabolism or tolerability of component drugs in the CMC regimen (see Appendix), and either of the following criteria are met:

Patients without a history of AIDS-defining opportunistic infections.

Patients with a history of AIDS-defining opportunistic infections, but they have not had an opportunistic infection within the past 12 months.

Patients with Hepatitis B (HBV): chronic carriers of HBV infection (HBsAg-positive) or individuals who have serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HBc-positive) are eligible if they are receiving appropriate suppressive antiviral therapy that does not include medications known to alter metabolism or tolerability of component drugs in CMC (see Appendix) prior to initiation of cancer therapy, and liver function tests meet study eligibility criteria.

Patients with Hepatitis C (HCV): patients with a history of HCV infection who have completed curative antiviral treatment are eligible if the HCV RNA viral load is below the limit of quantification within 90 days of study enrollment. Patients on concurrent HCV treatment must have HCV RNA viral load below the limit of quantification within 30 days of study enrollment. Patients must also meet liver function test eligibility requirements and antiviral therapy does not include medications known to alter metabolism or tolerability of component drugs in CMC.

Exclusion Criteria

Subjects meeting any of the criteria below are ineligible for this study:

Prior cytotoxic chemotherapy for this breast cancer

Any investigational agents administered during or within 2 weeks prior to start of CMC chemotherapy

AJCC stage IIIB-IIIC or stage IV

Active infection requiring systemic therapy

Untreated HIV/AIDS

Documented DYPD deficiency

Pregnant or nursing

Require anticoagulation with warfarin. Anticoagulation with low molecular weight heparins, heparin, or direct oral anticoagulants (DOACs) is permitted.

Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.

Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.

Other major comorbidity (e.g. advanced cardiopulmonary disease, uncontrolled diabetes mellitus) that may affect the safety or efficacy assessment of this investigational regimen, as determined by study PI

Inability to swallow pills

Any medical condition interfering with absorption of oral medications

Any contraindication for any chemotherapy drug used in the CMC regimen

Active and ongoing use of medicines known to alter metabolism or tolerability of component drugs in CMC.

Unable or unwilling to take a large number of oral pills

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 Chicago?

Yes, this clinical trial (NCT06085742) has an active research site in Chicago, IL 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 Chicago, IL

If you're searching for breast cancer treatment options in Chicago, IL, this clinical trial (NCT06085742) 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 Chicago 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 Chicago, IL

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About This Breast Cancer Study in Chicago