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Radiation

APBI for Improved Breast Appearance in Breast Cancer

Phase 2

Recruiting

Led By Jose G Bazan

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Patients must have pathologic Tis or T1 disease

Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-apbi qd

Awards & highlights

Study Summary

This trial tests a shorter course of radiation therapy (APBI) on breast cancer patients for improved appearance.

Who is the study for?

This trial is for women over 40 with early-stage, hormone-sensitive breast cancer who've had surgery with clear margins and no lymph node involvement. They must not be pregnant, breastfeeding, or have had prior cancer treatments. Participants need to agree to birth control use and understand English or Spanish.Check my eligibility

What is being tested?

The study tests a once-daily accelerated partial breast irradiation (APBI) regimen over consecutive business days for five treatments. APBI targets only the affected area of the breast rather than the whole breast, aiming for better cosmetic outcomes in low-risk patients.See study design

What are the potential side effects?

While specific side effects are not listed here, APBI may include skin changes like redness or irritation, fatigue, discomfort at the treatment site, and potential long-term changes in breast size or shape.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in the earliest stage.

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I had breast surgery with all cancer removed, confirmed by tests.

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My biopsy shows my cancer responds to hormones.

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I am 40 years old or older.

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I am female.

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My cancer is of the epithelial type, not lymphoma or sarcoma.

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My breast cancer is at an early stage (stage 0 or IA).

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I can read and understand either English or Spanish.

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My biopsy shows my cancer is not HER2 positive according to specific guidelines.

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My doctor rated my appearance as good or excellent after my lumpectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-apbi qd

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-apbi qd

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-apbi qd for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")

Secondary outcome measures

Cosmetic outcome assessed by the physician post-APBI QD

Cosmetic outcome by the patient post-APBI QD

Disease-free survival

+6 more

Side effects data

From 2021 Phase 2 trial • 200 Patients • NCT02526498

22%

Musculoskeletal and connective tissue disorders

20%

Injury, poisoning and procedural complications

18%

Reproductive system and breast disorder

15%

Breast Pain

14%

Dermatitis radiation

14%

Fibrosis deep connective tissue

10%

Superficial soft tissue fibrosis

Seroma

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (APBI Using HDR Brachytherapy)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (APBI)Experimental Treatment1 Intervention

Patients undergo APBI QD on consecutive business days for 5 treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Accelerated Partial Breast Irradiation

2015

Completed Phase 2

~200

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,612 Total Patients Enrolled

43 Trials studying Breast Cancer

6,649 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,118 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Jose G BazanPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

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

Is there a risk of harm associated with the use of APBI as a form of supportive care?

"Our team at Power gave Supportive care (APBI) a score of 2 as it is currently in Phase 2. This means that there is evidence backing the safety profile, yet no data demonstrating effectiveness."

Answered by AI

Are applications currently being accepted for this research initiative?

"According to records on clinicaltrials.gov, this medical investigation is not actively accepting participants. It has been since August 18th of 2023 that the trial was last modified and posted on September 9th of 2023. Despite this inactivity, there are still 4784 other trials currently seeking candidates for their research projects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer

2023. "Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008158.