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Sequential vs Concurrent Chemotherapy with Radiation for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Richard Zellars, MD

Research Sponsored by Richard Zellars

Eligibility Criteria Checklist

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

Must have

Medical Oncology consult with the recommendation of chemotherapy

Recommended regimens: Cyclophosphamide and Doxorubicin (AC), Taxotere, Doxorubicin and Cyclophosphamide (TAC), Taxotere and Cyclophosphamide (TC), or Taxotere, Carboplatin with Trastuzamab (TCH) prior to registration; or Paclitaxel and Trastuzumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-7 months

Awards & highlights

Study Summary

This trial is testing whether giving partial breast irradiation and chemotherapy at the same time has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times.

Who is the study for?

This trial is for women over 18 who've had breast cancer surgery with no remaining margins, have a performance status indicating they can carry out light activity, and need chemotherapy. They must not be pregnant, use effective birth control if of child-bearing potential, and have invasive adenocarcinoma of the breast treatable with specific chemo regimens.Check my eligibility

What is being tested?

The study compares two methods: partial breast irradiation (PBI) given at the same time as chemotherapy versus PBI followed by chemotherapy. Women will be randomly assigned to one of these treatments in a larger ratio favoring the new concurrent method.See study design

What are the potential side effects?

Side effects may include those typically associated with radiation therapy such as skin changes or fatigue, and those related to chemotherapy like nausea, hair loss, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My oncologist has recommended chemotherapy for me.

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I have been treated with specific chemotherapy regimens before joining.

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I am 18 years old or older.

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My breast cancer is confirmed to be invasive adenocarcinoma.

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My surgery removed all visible cancer without leaving any behind.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My breast cancer is in an early stage, with a small tumor and few affected lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-7 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Grade 3 or 4 short-term toxicity

Secondary outcome measures

Recurrent Brain Neoplasm

Long-term grade 3-4 toxicities

Quantify risks and benefits comparison for each arm

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PBI with chemotherapyExperimental Treatment1 Intervention

270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice

Group II: PBIActive Control1 Intervention

270 cGy (centigray) x 15

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Richard ZellarsLead Sponsor

1 Previous Clinical Trials

41 Total Patients Enrolled

1 Trials studying Breast Cancer

41 Patients Enrolled for Breast Cancer

Richard Zellars, MDPrincipal Investigator - Indiana University School of Medicine, Indiana University Simon Comprehensive Cancer Center

IU Health Methodist Hospital

Johns Hopkins University School Of Medicine (Medical School)

University Of Mi Hosps (Residency)

1 Previous Clinical Trials

41 Total Patients Enrolled

1 Trials studying Breast Cancer

41 Patients Enrolled for Breast Cancer

Media Library

Partial Breast Irradiation Clinical Trial Eligibility Overview. Trial Name: NCT01928589 — Phase 1 & 2

Breast Cancer Research Study Groups: PBI, PBI with chemotherapy

Breast Cancer Clinical Trial 2023: Partial Breast Irradiation Highlights & Side Effects. Trial Name: NCT01928589 — Phase 1 & 2

Partial Breast Irradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01928589 — Phase 1 & 2

Frequently Asked Questions

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

Does this research exclude patients who are octogenarians?

"This trial is open to patients aged 18-100. There are significantly more trials for older age brackets, with 2601 studies conducted on patients over 65 and only 76 focused on those under 18."

Answered by AI

Can you name all of the places where this research is being conducted?

"Currently, there are 6 sites across the United States enrolling patients for this clinical trial. They are located in York, Indianapolis, San Antonio and 3 other locations. To limit travel if you choose to enroll, please select the location nearest to you."

Answered by AI

Are people with the required conditions still able to join this experiment?

"That is right, the clinicaltrials.gov website indicates that this trial is actively seeking patients. The listing was created on September 1st 2013 and updated most recently on August 25th, 2020. There are 159 total spots available at 6 different hospitals or research centres."

Answered by AI

Is this study open to every patient or are specific inclusion criteria necessary?

"This study is recruiting 159 participants with breast cancer. Inclusion Criteria: Age ≥ 18 years. Patient must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma of the breast. Primary tumor ≤ 4cm and 0-3 positive axillary lymph nodes (T1-2, N0-1, M0). Margin negative surgery. For subjects with two breasts, they must have had a bilateral mammogram prior to surgery. Patient must have a Medical Oncology consult with the recommendation of chemotherapy. Recommended regimens are as follows: Cyclophosphamide and Dox"

Answered by AI

How many people are subjects in this experiment?

"That is correct. The online clinicaltrials.gov database shows that this research is currently looking for participants. This study was first advertised on September 1st, 2013 and the details were last updated on August 25th, 2022. They are hoping to enroll 159 individuals at 6 sites total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer

Richard Zellars 2014. "Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01928589.

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