What side effects are associated with this type of intervention?

Accelerated Partial Breast Irradiation (APBI) can cause side effects such as skin irritation, redness, breast pain, and fatigue. Long-term effects may include changes in breast appearance and texture. Endocrine Therapy, which includes medications like tamoxifen and aromatase inhibitors, can lead to hot flashes, joint pain, bone density loss, and an increased risk of cardiovascular issues. Both treatments aim to minimize the impact on quality of life while effectively managing breast cancer.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that align with the approaches studied in the CAMERAN trial. For localized radiation therapy, traditional whole-breast irradiation has been a standard, but more recently, techniques like Accelerated Partial Breast Irradiation (APBI) have gained approval for their targeted approach. In terms of endocrine therapy, drugs such as tamoxifen and aromatase inhibitors (e.g., anastrozole, letrozole) have been approved for hormone receptor-positive breast cancer. These therapies work by modulating hormonal pathways to inhibit cancer growth.

What other types of research exist?

Promising novel alternatives to APBI and Endocrine Therapy for breast cancer patients in 2024 include: 1) Immunotherapy, particularly immune checkpoint inhibitors, which have shown efficacy in various cancers including breast cancer. 2) Targeted therapies such as PARP inhibitors for patients with BRCA mutations. 3) Advanced radiation techniques like proton therapy, which may offer more precise targeting with fewer side effects. 4) Combination therapies that integrate novel agents with traditional treatments to enhance efficacy and reduce recurrence.

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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

Must not have

Synchronous bilateral breast cancer

Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two treatments for elderly women with low-risk breast cancer: targeted radiation and hormone-blocking medication. The goal is to see which treatment better improves quality of life while effectively controlling the cancer. The study will include women aged 65 and older with small, low-risk tumors. Recent trials have shown advantages in using newer hormone-blocking medications over the older standard treatment.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer in both breasts at the same time.

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I cannot have hormone or radiation therapy due to uncontrolled health issues.

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I have an autoimmune disease that increases my risk during radiation.

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My cancer has spread to parts of my body far from the original site.

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I had surgery to rearrange tissue in the area where my lump was removed.

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My cancer has multiple tumors in the same area.

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I have had radiation therapy to my chest or breast area before.

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I will receive chemotherapy before or after surgery while in this study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Disease

Endocrine therapy adherence

Overall survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Accelerated Partial Breast Irradiation (APBI) targets the lumpectomy cavity with localized radiation, delivering high doses over a short period to destroy any remaining cancer cells while sparing surrounding healthy tissue. This approach minimizes side effects and shortens treatment time, which can improve the patient's quality of life. Endocrine Therapy, on the other hand, involves hormonal modulation to block or lower estrogen levels, as many breast cancers are estrogen receptor-positive and rely on this hormone to grow. By using medications like tamoxifen or aromatase inhibitors, endocrine therapy reduces the risk of cancer recurrence and progression. Both treatments are crucial as they offer effective, targeted options with potentially fewer side effects, enhancing overall outcomes and quality of life for breast cancer patients.

Adjuvant endocrine therapy for premenopausal women with breast cancer.The breast cancer continuum in hormone-receptor-positive breast cancer in postmenopausal women: evolving management options focusing on aromatase inhibitors.