We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) (CAMERAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05472792
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Dana Lynne Casey, UNC Lineberger Comprehensive Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Quality of Life Radiation: Accelerated Partial Breast Irradiation (APBI) Drug: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 17, 2022
Estimated Primary Completion Date : May 17, 2024
Estimated Study Completion Date : May 17, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 years ]
    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. Overall survival [ Time Frame: 2 years ]
    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


Other Outcome Measures:
  1. Endocrine therapy adherence [ Time Frame: 5 years ]
    To measure the adherence to the planned endocrine therapy in the endocrine therapy alone arm using a medication usage questionnaire

  2. Disease-free survival [ Time Frame: 5 years ]
    To assess 5-year DFS-DCIS in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.

  3. Overall survival [ Time Frame: 5 years ]
    To assess 5-year OS in subjects who receive accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05472792


Contacts
Layout table for location contacts
Contact: Jessica Buddenbaum 919-966-4432 jessica_buddenbaum@med.unc.edu
Contact: Julie Maccarone 919-445-4922 julianna_maccarone@med.unc.edu

Locations
Layout table for location information
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dana Casey, MD    984-974-0400    dana_casey@med.unc.edu   
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Dana Casey, MD University of North Carolina, Chapel Hill
Layout table for additonal information
Responsible Party: Dana Lynne Casey, Assistant Professor- Department of Radiation Oncology, UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05472792    
Other Study ID Numbers: LCCC 2104
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dana Lynne Casey, UNC Lineberger Comprehensive Cancer Center:
Radiation Therapy
Endocrine Therapy
Partial Breast Irradiation
Elderly
Health Related Quality of Life
Patient Reported Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Toremifene
Letrozole
Fulvestrant
Anastrozole
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists