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Radiation Therapy

Partial Breast Irradiation for Breast Cancer

Q: In what geographical areas is this trial being conducted?

This trial is presently enrolling patients at 9 sites across the country, with key locations being Harrison, Uniondale and Rockville Centre. To reduce any inconveniences associated travelling to a clinic site, we recommend selecting the closest one to you.

Q: Are volunteers or participants currently being sought for this study?

According to the details available on clinicaltrials.gov, this trial is not recruiting at present. Initially posted in September of 2010 and last updated in October 2022, it does not appear that new participants are being added; however, 2600 other studies are looking for individuals to join their research efforts.

Q: Does the FDA permit physicians to use intensity-modulated or 3D-conformal radiation therapy techniques with multiple beams?

With a score of 2, the safety of multiple beams utilizing either intensity-modulated or 3D-conformal techniques is considered to be moderate. This assessment was based on the fact that this trial is in Phase 2 and has data supporting some level of safety but not yet efficacy.

Phase 2

Waitlist Available

Led By Simon Powell, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Unicentric Stage I (T1N0M0) invasive ductal breast cancer or Grade 1 or II DCIS measuring <2 cm on pathology and/or mammogram that is histologically confirmed at MSKCC

Patients with T1N0(i+) tumors on sentinel lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is comparing two types of radiation therapy given after breast surgery to see if one is better than the other.

Who is the study for?

This trial is for women over 18 with early-stage invasive ductal breast cancer or Grade 1/2 DCIS, measuring less than 2 cm. They must have a performance status indicating they can carry out daily activities without significant restrictions and adequate blood cell counts. Exclusions include prior breast surgeries, psychiatric conditions affecting consent, other ongoing cancer treatments, pregnancy/breastfeeding, certain genetic mutations like BRCA, and uncontrolled medical conditions.Check my eligibility

What is being tested?

The study tests Partial Breast Irradiation (PBI) as an alternative to Whole Breast Irradiation (WBI) in treating early-stage breast cancer post-lumpectomy. PBI targets only the tumor area for two weeks instead of the entire breast for five to seven weeks. The goal is to assess side effects and how effectively PBI prevents cancer recurrence.See study design

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of radiation therapy like PBI may include skin changes similar to sunburns in the treated area, fatigue due to body's repair response to radiation damage, mild swelling or tenderness of the breast tissue.

Eligibility Criteria

Inclusion Criteria

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

Select...

My breast cancer is early stage, small, and confirmed by tests at MSKCC.

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My cancer is in an early stage and was found in a sentinel lymph node but is very small.

Select...

I am 18 years old or older.

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I am fully active or can carry out light work.

Select...

My blood test shows enough granulocytes and platelets for chemotherapy.

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My cancer surgery showed clear margins of 2mm or more, or no cancer in the final tissue removed.

Select...

I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To evaluate the safety of PBI-directed external-beam radiation therapy

Secondary outcome measures

To evaluate breast cosmesis

To evaluate distant control rates

To evaluate local control rates

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation treatmentExperimental Treatment1 Intervention

This is a Phase II single-arm study of PBI with external-beam radiation therapy in which a group of select women with early-stage invasive and noninvasive breast cancer will be given radiation to the partial breast.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,510 Total Patients Enrolled

202 Trials studying Breast Cancer

81,027 Patients Enrolled for Breast Cancer

Simon Powell, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

116 Total Patients Enrolled

1 Trials studying Breast Cancer

116 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

In what geographical areas is this trial being conducted?

"This trial is presently enrolling patients at 9 sites across the country, with key locations being Harrison, Uniondale and Rockville Centre. To reduce any inconveniences associated travelling to a clinic site, we recommend selecting the closest one to you."

Answered by AI

Are volunteers or participants currently being sought for this study?

"According to the details available on clinicaltrials.gov, this trial is not recruiting at present. Initially posted in September of 2010 and last updated in October 2022, it does not appear that new participants are being added; however, 2600 other studies are looking for individuals to join their research efforts."

Answered by AI

Does the FDA permit physicians to use intensity-modulated or 3D-conformal radiation therapy techniques with multiple beams?

"With a score of 2, the safety of multiple beams utilizing either intensity-modulated or 3D-conformal techniques is considered to be moderate. This assessment was based on the fact that this trial is in Phase 2 and has data supporting some level of safety but not yet efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer

2010. "Partial Breast Irradiation (PBI) Using 40 Gy for Select Patients With Early Invasive or Noninvasive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01203839.