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

• ClinicalTrials.gov Identifier: NCT05472792
• Recruitment Status: Recruiting
• First Posted: July 25, 2022
• Last Update Posted: October 17, 2022
• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Information provided by (Responsible Party): Dana Lynne Casey, UNC Lineberger Comprehensive Cancer Center

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Jessica Buddenbaum; 919-966-4432; jessica_buddenbaum@med.unc.edu

Contact: Julie Maccarone; 919-445-4922; julianna_maccarone@med.unc.edu

Locations

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

• Principal Investigator: Dana Casey, MD; University of North Carolina, Chapel Hill

More 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
• Last Update Posted: October 17, 2022
• Last Verified: October 2022

• 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

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:

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