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

Primary Purpose

Breast Cancer, Quality of Life

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Accelerated Partial Breast Irradiation (APBI)
tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Radiation Therapy, Endocrine Therapy, Partial Breast Irradiation, Elderly, Health Related Quality of Life, Patient Reported Outcomes

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endocrine Therapy

Accelerated Partial Breast Irradiation (APBI)

Arm Description

Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient.

APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 18, 2022
Last Updated
June 12, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05472792
Brief Title
Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)
Acronym
CAMERAN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 17, 2024 (Anticipated)
Study Completion Date
May 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life
Keywords
Radiation Therapy, Endocrine Therapy, Partial Breast Irradiation, Elderly, Health Related Quality of Life, Patient Reported Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endocrine Therapy
Arm Type
Active Comparator
Arm Description
Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient.
Arm Title
Accelerated Partial Breast Irradiation (APBI)
Arm Type
Experimental
Arm Description
APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity.
Intervention Type
Radiation
Intervention Name(s)
Accelerated Partial Breast Irradiation (APBI)
Intervention Description
Radiation treatment delivered to the lumpectomy cavity.
Intervention Type
Drug
Intervention Name(s)
tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Intervention Description
Adjuvant endocrine therapy (tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene) for duration of 5 years, as tolerated by the patient.
Primary Outcome Measure Information:
Title
Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Description
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.
Time Frame
1 year
Title
Patient reported outcomes assessed by EORTC QLQ-BR45
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
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
Time Frame
2 years
Title
Overall survival
Description
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
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Endocrine therapy adherence
Description
To measure the adherence to the planned endocrine therapy in the endocrine therapy alone arm using a medication usage questionnaire
Time Frame
5 years
Title
Disease-free survival
Description
To assess 5-year DFS-DCIS in subjects who have received accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.
Time Frame
5 years
Title
Overall survival
Description
To assess 5-year OS in subjects who receive accelerated partial breast irradiation alone versus endocrine therapy alone after breast conserving surgery.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Buddenbaum
Phone
919-966-4432
Email
jessica_buddenbaum@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Maccarone
Phone
919-445-4922
Email
julianna_maccarone@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Casey, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Casey, MD
Phone
984-974-0400
Email
dana_casey@med.unc.edu

12. IPD Sharing Statement

Learn more about this trial

Comparison of 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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