RecruitingPhase 2NCT05472792

Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

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


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

90 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for older women with early-stage breast cancer after a lumpectomy (breast-conserving surgery): hormone therapy alone versus a short course of targeted radiation to the tumor area (accelerated partial breast irradiation, or APBI). **You may be eligible if...** - You are a woman aged 65 or older - You have been newly diagnosed with early-stage (T1), hormone receptor-positive (ER+/PR+), HER2-negative invasive breast cancer - Your tumor is grade 1 or 2 (slower growing) - You had clear surgical margins (no cancer cells at the edges) after a lumpectomy - You have no lymph node involvement and no signs of lymphovascular invasion **You may NOT be eligible if...** - You received chemotherapy before or after surgery - You are pregnant - Your cancer has HER2 overexpression - You have had prior radiation to the chest area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONAccelerated Partial Breast Irradiation (APBI)

Radiation treatment delivered to the lumpectomy cavity.

DRUGtamoxifen, 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(1)

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT05472792


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