NCT05472792 · UNC Lineberger Comprehensive Cancer Center
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
(CAMERAN)
What this study is about
The aim of this forward-looking study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomly assigned to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy.
View original scientific description
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.
Interventions
RADIATION
Accelerated Partial Breast Irradiation (APBI)
Radiation treatment delivered to the lumpectomy cavity.
DRUG
tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Adjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient.
Primary outcome measures
Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Time frame: 1 year
To compare quality of life at 1 year after breast conserving surgery in those who receive adjuvant accelerated partial breast irradiation alone versus adjuvant endocrine therapy alone as measured by the EORTC QLQ-C30. Raw scores are linearly converted to a 0-100 scale with higher symptom scales reflecting increased levels of symptom burden.
Patient reported outcomes assessed by EORTC QLQ-BR45
Time frame: 1 year
To compare quality of life at 1 year after breast conserving surgery in those who receive adjuvant accelerated partial breast irradiation alone versus adjuvant endocrine therapy alone as measured by the EORTC QLQ-BR45. Raw scores are linearly converted to a 0-100 scale with higher symptom scales reflecting increased levels of symptom burden.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chapel Hill, North Carolina
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Frequently asked questions
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations