RECRUITING

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

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Conditions

Breast CancerQuality of LifeRadiation TherapyEndocrine TherapyPartial Breast IrradiationElderlyHealth Related Quality of LifePatient Reported Outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2022-05-17
Study Completion:2032-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05472792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.
  3. 3. Pathological T1 (pT1) stage
  4. 4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining)
  5. 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. 6. Grade 1 or 2 overall tumor grade
  7. 7. Clinical or pathological N0
  8. 8. No lymphovascular space invasion (LVSI)
  9. 9. Final surgical margins ≥ 2 mm as per APBI criteria
  10. 10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
  11. 11. Suitable for APBI as deemed by the treating radiation oncologist
  12. 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. 13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial
  1. 1. Pre- or post-operative systemic chemotherapy while on this study.
  2. 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. 3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization).
  4. 4. Multifocal or multicentric tumor.
  5. 5. Receipt of tissue rearrangement in the lumpectomy cavity.
  6. 6. Synchronous bilateral breast cancer.
  7. 7. Clinical or imaging evidence of distant metastases.
  8. 8. Prior breast or thoracic radiation.
  9. 9. Autoimmune conditions with associated radiation risks.
  10. 10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.

Contacts and Locations

Study Contact

Lori Stravers
CONTACT
+1 919-966-4432
lori_stravers@med.unc.edu
Jessica Buddenbaum
CONTACT
919-966-4432
jessica_buddenbaum@med.unc.edu

Principal Investigator

Dana Casey, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Dana Casey, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-17
Study Completion Date2032-04-15

Study Record Updates

Study Start Date2022-05-17
Study Completion Date2032-04-15

Terms related to this study

Keywords Provided by Researchers

  • Radiation Therapy
  • Endocrine Therapy
  • Partial Breast Irradiation
  • Elderly
  • Health Related Quality of Life
  • Patient Reported Outcomes

Additional Relevant MeSH Terms

  • Breast Cancer
  • Quality of Life