Breast Radiation Therapy vs Hormonal Therapy for Elderly Patients
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
Recruiting
Phase 2
Interventional Study
Breast Cancer
Quality of Life
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for women aged 65 and older who have been diagnosed with low-risk breast cancer. Participants will receive either radiation therapy or hormonal therapy after their surgery and will help researchers compare the effects on quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a woman aged 65 or older.
- I have been diagnosed with invasive breast cancer.
- My tumor is 2 cm or smaller.
- My breast cancer is hormone receptor positive.
- I have not had lymph node involvement.
- I have completed breast-conserving surgery.
- I can provide consent to participate in the study.
- I have no lymphovascular space invasion.
You may not be able to join if
- I am currently receiving chemotherapy.
- I am currently taking anti-hormonal agents.
- I have multiple tumors in my breast.
- I have distant spread of my cancer.
- I have had radiation treatment to my breast before.
- I have uncontrolled medical conditions that affect my treatment.
- I have current autoimmune conditions with radiation risks.
- I have bilateral breast cancer occurring at the same time.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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…
Trial Locations
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Eligibility 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) sta…
Contacts