Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy (CAMERAN)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Breast Cancer
• Intervention / Treatment: Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene; Radiation: Accelerated Partial Breast Irradiation (APBI)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lori Stravers; Phone Number: +1 919-966-4432; Email: lori_stravers@med.unc.edu
• Study Contact Backup: Name: Jessica Buddenbaum; Phone Number: 919-966-4432; Email: jessica_buddenbaum@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: Dana Casey, MD; Phone Number: 984-974-0400; Email: dana_casey@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.
3. Pathological T1 (pT1) stage
4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry [IHC] staining)
5. 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])
6. Grade 1 or 2 overall tumor grade
7. Clinical or pathological N0
8. No lymphovascular space invasion (LVSI)
9. Final surgical margins ≥ 2 mm as per APBI criteria
10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
11. Suitable for APBI as deemed by the treating radiation oncologist
12. 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.
13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial

Exclusion Criteria:

1. Pre- or post-operative systemic chemotherapy while on this study.
2. 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.
3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization).
4. Multifocal or multicentric tumor.
5. Receipt of tissue rearrangement in the lumpectomy cavity.
6. Synchronous bilateral breast cancer.
7. Clinical or imaging evidence of distant metastases.
8. Prior breast or thoracic radiation.
9. Autoimmune conditions with associated radiation risks.
10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endocrine Therapy; Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient.	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.
Experimental: Accelerated Partial Breast Irradiation (APBI); APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity.	Radiation: Accelerated Partial Breast Irradiation (APBI); Radiation treatment delivered to the lumpectomy cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocrine therapy adherence	To measure the adherence to the planned endocrine therapy in the endocrine therapy alone arm using a medication usage questionnaire	5 years
Disease-free survival	To assess 5-year DFS-DCIS in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.	5 years
Overall survival	To assess 5-year OS in subjects who receive accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.	5 years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Dana Casey, MD, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2032

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Radiation Therapy; Patient Reported Outcomes; Endocrine Therapy; Health Related Quality of Life; Partial Breast Irradiation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Benzene Derivatives; Nitriles; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Triazoles; Stilbenes; Benzylidene Compounds; Letrozole; Fulvestrant; Anastrozole; Tamoxifen; Toremifene; exemestane
• Other Study ID Numbers: LCCC2104-DCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No