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APBI vs Endocrine Therapy for Breast Cancer (CAMERAN Trial)

Phase 2

Recruiting

Led By Dana Casey, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Grade 1 or 2 overall tumor grade

Final surgical margins ≥ 2 mm as per APBI criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

CAMERAN Trial Summary

This trial is testing whether accelerated partial breast irradiation (APBI) is better than endocrine therapy in terms of quality of life for elderly patients with low-risk breast cancer.

Who is the study for?

This trial is for women over 65 with early-stage, low-risk breast cancer (small tumors under 2cm, not aggressive, and no spread to lymph nodes). Participants should be healthy enough for hormone therapy or radiation and have a positive hormone receptor status. They must not have other cancers that could affect the study or serious uncontrolled medical conditions.Check my eligibility

What is being tested?

The CAMERAN study compares two treatments after lumpectomy in older women with low-risk breast cancer: one group receives accelerated partial breast irradiation (APBI) alone, while another gets endocrine therapy alone. The goal is to see which treatment offers better quality of life without compromising disease control.See study design

What are the potential side effects?

Potential side effects from APBI include skin changes like redness and soreness at the treatment site, fatigue, and rare risks associated with radiation. Endocrine therapies may cause hot flashes, mood swings, bone thinning or joint pain.

CAMERAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at an early stage (grade 1 or 2).

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My cancer surgery removed all visible cancer with at least 2 mm of clear tissue around it.

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My cancer is in the early stage (stage 1).

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My cancer is HER2-negative according to specific guidelines.

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My cancer has not spread to nearby lymph nodes.

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My cancer is at least 10% positive for both estrogen and progesterone receptors.

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I've had surgery to remove part of my breast, possibly with lymph node removal.

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I am a woman aged 65 or older with a new breast cancer diagnosis.

CAMERAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient reported outcomes assessed by EORTC QLQ-BR45

Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30

Other outcome measures

Disease

Endocrine therapy adherence

Overall survival

CAMERAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Accelerated Partial Breast Irradiation (APBI)Experimental Treatment1 Intervention

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

Group II: Endocrine TherapyActive Control1 Intervention

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,243 Total Patients Enrolled

51 Trials studying Breast Cancer

27,896 Patients Enrolled for Breast Cancer

Dana Casey, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

2 Previous Clinical Trials

284 Total Patients Enrolled

Media Library

Accelerated Partial Breast Irradiation (APBI) Clinical Trial Eligibility Overview. Trial Name: NCT05472792 — Phase 2

Breast Cancer Research Study Groups: Endocrine Therapy, Accelerated Partial Breast Irradiation (APBI)

Breast Cancer Clinical Trial 2023: Accelerated Partial Breast Irradiation (APBI) Highlights & Side Effects. Trial Name: NCT05472792 — Phase 2

Accelerated Partial Breast Irradiation (APBI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472792 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool expanding for this medical research?

"Yes, according to clinicaltrials.gov, this research project is actively recruiting individuals for participation. This trial was made public on May 17th 2022 and the last update occurred on October 12th of that same year with 90 participants being sought from 1 medical centre."

Answered by AI

Is enrollment for this trial currently open to participants?

"Clinicaltrials.gov evidences that this trial is actively seeking volunteers, having initially been posted on May 17th 2022 and most recently updated October 12th of the same year."

Answered by AI

Has the FDA approved Accelerated Partial Breast Irradiation (APBI) for use in patients?

"Our internal assessment at Power rated Accelerated Partial Breast Irradiation (APBI) as a 2 on the 1-3 scale. This is due to existing data backing its safety, but none which have looked into its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dana Lynne Casey 2022. "Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05472792.

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