Chapel Hill, NCNCT05472792Now EnrollingIRB Ready

Breast Cancer Clinical Trial in Chapel Hill, NC

Access cutting-edge breast cancer treatment through this phase 2 clinical trial at a research site in Chapel Hill. Study-provided care at no cost to qualified participants.

Sponsored by UNC Lineberger Comprehensive Cancer Center

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Expert Care in Chapel Hill

Access breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related breast cancer treatment provided free

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Check if you qualify for this breast cancer clinical trial in Chapel Hill, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Chapel Hill

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chapel Hill site if eligible
  4. 4Begin participation

About This Breast Cancer Study in Chapel Hill

The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

Sponsor: UNC Lineberger Comprehensive Cancer Center

Who Can Participate

Inclusion Criteria

Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.
Pathological T1 (pT1) stage
Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining)
Human epidermal growth factor receptor 2 (HER2) - according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization \[ISH\])
Grade 1 or 2 overall tumor grade
Clinical or pathological N0
No lymphovascular space invasion (LVSI)
Final surgical margins ≥ 2 mm as per APBI criteria
Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
Suitable for APBI as deemed by the treating radiation oncologist
Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

Exclusion Criteria

Pre- or post-operative systemic chemotherapy while on this study.
Current ongoing treatment with anti-hormonal agents. If previously on anti-hormonal agents and planning to stop, the subject must discontinue within 30 days of randomization.
Hormonal replacement therapy (eligible if discontinued within 30 days of randomization).
Multifocal or multicentric tumor.
Receipt of tissue rearrangement in the lumpectomy cavity.
Synchronous bilateral breast cancer.
Clinical or imaging evidence of distant metastases.
Prior breast or thoracic radiation.
Autoimmune conditions with associated radiation risks.
Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.

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 Chapel Hill?

Yes, this clinical trial (NCT05472792) has an active research site in Chapel Hill, NC 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 Chapel Hill, NC

If you're searching for breast cancer treatment options in Chapel Hill, NC, this clinical trial (NCT05472792) 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 Chapel Hill 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.

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