What side effects are associated with this type of intervention?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, and endocrine therapy. Surgery can lead to pain, infection, and lymphedema. Chemotherapy often causes nausea, hair loss, fatigue, and increased risk of infection. Endocrine therapy may result in hot flashes, mood swings, and bone thinning. For radiation therapy, typical side effects include skin irritation, fatigue, and breast swelling. Specifically, for shortened radiation therapy with increased dose per session, patients may experience more intense skin reactions, greater fatigue, and a higher risk of long-term skin changes and fibrosis.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including radiation therapy, which is a cornerstone in managing the disease, especially post-surgery. Traditional radiation therapy typically involves lower doses over a longer period. However, recent studies and clinical trials are exploring shorter course radiation therapy, which involves higher doses per session to reduce the overall treatment time. This approach aims to maintain efficacy while improving patient convenience and reducing side effects. While specific FDA approvals for this exact regimen are still under investigation, the concept aligns with the broader trend of optimizing radiation therapy protocols for better patient outcomes.

What other types of research exist?

Promising novel alternatives to shortened radiation therapy for breast cancer patients include: 1) Accelerated Partial Breast Irradiation (APBI) using techniques like brachytherapy or 3D conformal radiotherapy, which target only the tumor bed and reduce treatment time. 2) Intensity-Modulated Radiation Therapy (IMRT) for more precise targeting of cancer cells while sparing healthy tissue. 3) Hypofractionated radiation therapy, which involves fewer, higher-dose treatments over a shorter period. 4) Proton therapy, which offers precise radiation delivery with minimal damage to surrounding tissues. These alternatives have shown efficacy in clinical trials and may provide better cosmetic outcomes and reduced toxicity.

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Radiation

Shorter Course Radiation for Breast Cancer

Phase 2

Waitlist Available

Led By Christine Fisher, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology

The patient must have an ECOG performance status of 0 or 1 (KPS >70%)

Must not have

Patients with prior ipsilateral thoracic or breast radiation

Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, quicker way to give radiation therapy to breast cancer patients who have had surgery and have cancer cells in their lymph nodes. The treatment aims to deliver the same total amount of radiation in less time, which has been shown to be safe and effective for breast tissue but needs more testing for larger areas. Recent trials have shown that these methods are safe and effective for breast tissue.

Who is the study for?

This trial is for adult women with breast cancer who've had surgery and found cancer in their lymph nodes. They must be under 50, may have had chemo, and should not have severe side effects from past treatments. Their last surgery or chemo should be within the past 180 days, they need to understand and agree to the study by signing a consent form.

What is being tested?

The study tests a shorter radiation treatment schedule for breast cancer that has spread to lymph nodes after surgery. It aims to see if this quicker method is as effective as traditional longer courses of radiation therapy.

What are the potential side effects?

While specific side effects are not listed here, typical ones from radiation may include skin irritation at the treatment site, fatigue, mild swelling in treated area, and changes in breast texture.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult woman with breast cancer, had surgery, and my lymph nodes were affected.

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I am fully active or able to carry out light work.

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I have had either a total mastectomy or a lumpectomy.

Exclusion Criteria

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

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I have had radiation therapy on the same side of my chest or breast before.

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I have an active collagen disease like lupus, scleroderma, or dermatomyositis with symptoms.

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I have had another type of cancer besides skin cancer within the last 5 years.

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I am a male.

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I am a woman with advanced breast cancer.

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I have chosen not to have or haven't had surgery for my condition.

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I am a woman who had cancer cells found at the edge of the tissue removed during my first surgery.

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My breast cancer has not spread to my lymph nodes.

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My cancer has not been confirmed to spread to my lymph nodes.

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My cancer has spread to lymph nodes in a way that surgery can't easily remove.

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I have cancer in both breasts at the same time.

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My cancer has spread far, or I've been told I have less than 5 years to live.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants reporting shoulder stiffness as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C3014) and breast-cancer module (BR23)

Lymphedema

Number of participants with new development of ischemic heart disease as measured by EKG

+2 more

Secondary study objectives

Number of participants with a change in quality of life score as measured by the EORTC QLQ-C3014 and breast-cancer module (BR23)

Number of participants with disease recurrence

Number of participants with local-regional failure free survival

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adjuvant Hypofractionated RadiationExperimental Treatment1 Intervention

Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.

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

Breast cancer treatments work through various mechanisms to eliminate cancer cells and prevent recurrence. Surgery physically removes the tumor, while radiation therapy uses high-energy rays to destroy remaining cancer cells in the breast or surrounding tissues. Chemotherapy employs cytotoxic drugs to kill rapidly dividing cells throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapy attacks specific molecules involved in cancer growth. Shortened radiation therapy, which delivers higher doses per session over a shorter period, is significant for patients as it reduces the overall treatment time, potentially improving convenience and adherence while maintaining efficacy.

High-dose therapy for breast cancer - a case of suspended animation.