Is NCT06218303 recruiting in Pittsburgh, PA?

Yes, NCT06218303 is currently recruiting participants at its Pittsburgh, PA location. This ductal carcinoma in situ clinical trial is actively enrolling qualified participants.

How do I join the ductal carcinoma in situ clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, 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 Pittsburgh 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.

Ductal Carcinoma in Situ Clinical Trial in Pittsburgh, PA

About This Ductal Carcinoma in Situ Study in Pittsburgh

Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

Sponsor: Finn, Olivera, PhD

Who Can Participate

Inclusion Criteria

Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.

Capable of providing informed consent and willing to comply with study procedures

Biopsy-proven ER+ DCIS

The signed pathology report from the attending pathologist will be used to determine eligibility

Sufficient amount of DCIS remaining in the diagnostic core biopsy block(s) and available for research

Patients with DCIS suspicious for microinvasion on core biopsy will be eligible because many of these patients will not have invasion on final pathology

Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below

DCIS must be ≥ 1cm based on the extent of calcifications on mammogram, the presence of a mass on ultrasound or enhancement on MRI OR DCIS ≥ 5mm on one single core by pathologic evaluation OR DCIS \< 5mm if identified in ≥ 2 cores

Candidate for selective estrogen receptor modulator or aromatase inhibitor

Surgery planned as part of definitive local therapy

ECOG PS 0-1

Absolute neutrophil count ≥ 1.5 x 109/L

Platelet count ≥ 100 x 109/L

Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L

Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min

Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease

AST and ALT ≤ 2.5X ULN

INR/PT/aPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation

If pre-menopausal, negative urine or serum pregnancy test

Exclusion Criteria

Invasive breast cancer \> 1mm on pathologic evaluation

Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)

Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study

Recurrent ipsilateral DCIS

Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed)

Current Immunomodulator therapy (includes anti-CD20 antibodies)

History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable.

History of immune deficiency

Active infection requiring systemic therapy

Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient's participation for the full duration of the study or compliance with the requirements of the study

Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus RNA positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by PCR.

Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2)

Received a live vaccine within 30 days of the first dose of treatment

History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant

Participation on any investigational vaccine, drug, or device trial within the last 30 days

Pregnant or breastfeeding

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 Pittsburgh?

Yes, this clinical trial (NCT06218303) has an active research site in Pittsburgh, PA 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.

Ductal Carcinoma in Situ Treatment Options in Pittsburgh, PA

If you're searching for ductal carcinoma in situ treatment options in Pittsburgh, PA, this clinical trial (NCT06218303) 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 Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ductal carcinoma in situ 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 ductal carcinoma in situ clinical trials near you to find additional studies recruiting in your area.

Ductal Carcinoma in Situ Clinical Trial in Pittsburgh, PA

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