Breast CancerPhase 2CAMERANNCT05472792
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
A Phase 2 study testing Accelerated Partial Breast Irradiation (APBI) and tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene in people with Breast Cancer and Quality of Life, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life
- What is being tested?
- Accelerated Partial Breast Irradiation (APBI) and tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 15 Apr 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Dana Casey, MD, 984-974-0400, dana_casey@med.unc.edu
About this study
Official title: Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)
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.
- Conditions
- Breast Cancer, Quality of Life
- Being tested
- Accelerated Partial Breast Irradiation (APBI), tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
- Keywords
- Radiation Therapy, Endocrine Therapy, Partial Breast Irradiation, Elderly, Health Related Quality of Life, Patient Reported Outcomes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Partial Breast Irradiation (APBI)Radiation
Radiation treatment delivered to the lumpectomy cavity.
tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifeneDrug
Adjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Endocrine Therapy | Active comparator | Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Receives: Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene |
| Accelerated Partial Breast Irradiation (APBI) | Experimental | APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Receives: Radiation: Accelerated Partial Breast Irradiation (APBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
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.
Measured: 1 year
Patient reported outcomes assessed by EORTC QLQ-BR45
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.
Measured: 1 year
Secondary outcomes (2)
Disease-free survival
To assess the 2-year outcome of disease-free survival, including DCIS (DFS-DCIS), in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery
Measured: 2 years
Overall survival
To assess the 2-year overall survival (OS) in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start17 May 2022
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Casey, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472792
- Sponsor's protocol ID
- LCCC2104-DCT
- Acronym
- CAMERAN
- Status last verified
- May 2026
- First submitted
- 18 Jul 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)
- ClinicalTrials.gov ID
- NCT05472792
- Acronym / sponsor ID
- CAMERAN / LCCC2104-DCT
- Conditions
- Breast Cancer, Quality of Life
- Keywords
- Radiation Therapy, Endocrine Therapy, Partial Breast Irradiation, Elderly, Health Related Quality of Life, Patient Reported Outcomes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2032 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrine Therapy | Active comparator | Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifeneEndocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. |
| Accelerated Partial Breast Irradiation (APBI) | Experimental | Radiation: Accelerated Partial Breast Irradiation (APBI)APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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])
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Partial Breast Irradiation (APBI)Radiation treatment delivered to the lumpectomy cavity. | Radiation | Accelerated Partial Breast Irradiation (APBI) |
| tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifeneAdjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient. | Drug | Endocrine Therapy |
Primary outcome
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.
2 secondary outcomes
Disease-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dana Casey, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accelerated Partial Breast Irradiation (APBI) and tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene in people with Breast Cancer and Quality of Life, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Stravers (+1 919-966-4432, lori_stravers@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.