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Radiation Therapy

Targeted Radiation Therapy for Breast Cancer (Second Chance Trial)

Phase 2
Recruiting
Led By John Ng, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
No synchronous distant metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year from completion of radiation treatment
Awards & highlights

Second Chance Trial Summary

This trial is testing a new way to give radiation therapy that may help women who have had a breast recurrence after a lumpectomy.

Who is the study for?
This trial is for adults who've had breast cancer return in the same breast after lumpectomy and radiation. They should have a small, single tumor (less than 2-3 cm) without skin involvement or distant spread, up to three positive lymph nodes, clear margins from surgery, and it must be at least a year since their first treatment.Check my eligibility
What is being tested?
The study tests partial breast irradiation focused on the surgical bed with some margin around it. The aim is to see if this can offer another chance at preserving the breast in patients who've had previous lumpectomy and radiotherapy but now face recurrence.See study design
What are the potential side effects?
While specific side effects are not listed here, generally speaking, radiation therapy can cause skin changes like redness and irritation, fatigue, swelling of the treated breast (lymphedema), and sometimes may affect nearby organs such as the heart or lungs.

Second Chance Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have up to 3 lymph nodes with cancer but no spread beyond their capsule.
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My cancer has not spread to distant parts of my body.
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I am 18 years old or older.
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I have a single breast tumor on one side.
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I have been diagnosed with breast cancer.
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My tumor is smaller than 3 cm and does not affect the skin.

Second Chance Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year from completion of radiation treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year from completion of radiation treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of treatment related adverse events as graded by CTCAE version 5.0
Secondary outcome measures
Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS)
Change in number of participants with skin changes
Disease free survival (DFS) will be measured
+4 more

Second Chance Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation TherapyExperimental Treatment1 Intervention
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT).

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,468 Total Patients Enrolled
29 Trials studying Breast Cancer
27,156 Patients Enrolled for Breast Cancer
John Ng, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
380 Total Patients Enrolled
1 Trials studying Breast Cancer
380 Patients Enrolled for Breast Cancer

Media Library

Partial Breast Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04371913 — Phase 2
Breast Cancer Research Study Groups: Radiation Therapy
Breast Cancer Clinical Trial 2023: Partial Breast Irradiation Highlights & Side Effects. Trial Name: NCT04371913 — Phase 2
Partial Breast Irradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04371913 — Phase 2

Frequently Asked Questions

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

What is the current sample size of this medical research?

"Affirmative. Clinicaltrials.gov reports that this clinical trial is actively seeking enrolment, having first gone live on June 30th 2020 and updated for the last time on July 29th 2022. The study needs to enroll 60 patients from 3 distinct sites in order to complete its objectives."

Answered by AI

What are the dangers associated with administering this treatment to patients?

"Our experts at Power rated this treatment's safety, on a scale of 1 to 3, as 2. This is due to the fact that only Phase 2 trial data exists for the drug, and it shows some evidence of safety features but none concerning its efficacy."

Answered by AI

Is enrollment for this experiment currently taking place?

"Affirmative. As of July 29th 2022, clinicaltrials.gov data shows that this medical trial is still seeking participants. It was initially posted on June 30th 2020 and seeks to enlist 60 individuals from 3 different sites."

Answered by AI

Am I eligible to join the research project?

"For this clinical trial, 60 individuals with breast cancer between the ages of 19 and 90 are being admitted. In addition to meeting these age requirements, participants must have had at least 12 months since their initial breast conserving treatment (surgery plus radiotherapy) before recurrence; be devoid of synchronous distant metastases; possess an isolated ipsilateral unifocal lesion that is under 2-3 cm in size without skin involvement; and present technical feasibility."

Answered by AI

Is this trial open to those under 85 years of age?

"This trial only enrolls patients aged 19 to 90. Conversely, for those younger than 18 and older than 65 there are 52 studies and 1334 studies respectively available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
2020. "Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04371913.
~18 spots leftby Dec 2025
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