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Sequential vs Concurrent Chemotherapy with Radiation for Breast Cancer

Phase 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
Must not have
Received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer
Squamous cell cancer or sarcomas of the breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-7 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received initial treatment with chemotherapy or hormone therapy for my current cancer.
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My breast cancer is either squamous cell or sarcoma.
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I had breast cancer on the same side and have been cancer-free for less than 5 years.
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My cancer is currently active in its original location or nearby.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 3 or 4 short-term toxicity
Secondary study objectives
Recurrent Brain Neoplasm
Long-term grade 3-4 toxicities
Quantify risks and benefits comparison for each arm
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Richard ZellarsLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Breast Cancer
19 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
19 Total Patients Enrolled
1 Trials studying Breast Cancer
19 Patients Enrolled for Breast Cancer

Media Library

Partial Breast Irradiation Clinical Trial Eligibility Overview. Trial Name: NCT01928589 — Phase 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 2
Partial Breast Irradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01928589 — Phase 2
~7 spots leftby Oct 2025
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