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

Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472792
• Other study ID #: LCCC 2104
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2022
• Est. completion date: April 15, 2032

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Lori Stravers
• Phone: +1 919-966-4432
• Email: lori_stravers[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 15, 2032
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Intervention

Radiation:
• Accelerated Partial Breast Irradiation (APBI)
Radiation treatment delivered to the lumpectomy cavity.

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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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