Is NCT03936478 recruiting in Madison, WI?

Yes, NCT03936478 is currently recruiting participants at its Madison, WI location. This breast cancer clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Madison, 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 Madison 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 Madison, WI

About This Breast Cancer Study in Madison

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

Sponsor: University of Wisconsin, Madison

Who Can Participate

Inclusion Criteria

For all participants

Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.

Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.

Pregnancy test negative in women of child bearing potential (WOCBP).

The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.

Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. For participants with Invasive Carcinoma

Age: \>=50 years

Margins: Negative by at least 2 mm

T Stage: Tis or T1

Cautionary:

Age: 40-49 years

Margins: Negative by at least 2 mm

T Stage: Tis or T1 OR

Age: \>=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)

Pathologic Factors:

Size 2.1-3.0 cm (size of the invasive component)

Close margins (\<2 mm)

Limited/focal Lymphovascular Space Invasion (LVSI)

Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).

Invasive lobular histology

Extensive Intraductal Component (EIC) \<=3 cm For participants with DCIS

Suitable Criteria, DCIS allowed if all of the following are met:

Screen-detected

Low to intermediate nuclear grade

Size \<=2.5 cm

Resected with margins negative at \>=3mm OR

Cautionary Criteria:

Pure DCIS \<=3 cm if "suitable" criteria not fully met

Exclusion Criteria

(unsuitable criteria) :

Men are not eligible for this study.

BRCA1/2 mutation positivity.

Age \< 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).

Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).

Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.

Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.

Non-epithelial breast malignancies such as sarcoma or lymphoma.

Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).

Pure DCIS \>3 cm in size (ASTRO Unsuitable Criteria).

Presence of extensive intraductal component \>30mm (ASTRO Unsuitable Criteria).

Paget's disease of the nipple.

History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)

Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.

Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.

Breast implants.

Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.

Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.

Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.

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 Madison?

Yes, this clinical trial (NCT03936478) has an active research site in Madison, WI 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 Madison, WI

If you're searching for breast cancer treatment options in Madison, WI, this clinical trial (NCT03936478) 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 Madison 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 Madison, WI

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