๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-05

Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer (NCT01928589)

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Richard Zellars

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (1 items).

Location: Sibley Memorial Hospital โ€” Washington D.C., District of Columbia

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer. Patients with squamous cell cancer or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient with a prior ipsilateral breast cancer (invasive or non-invasive) from which the patient has been disease free for less than 5 years. Patient is pregnant. Patient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatment. Study team (PI, Co-I, and or research nurse) may deny enrollment if in the study team's opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-ups.

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • Sibley Memorial Hospital โ€” Washington D.C., District of Columbia
  • Parkview Regional Medical Center โ€” Fort Wayne, Indiana
  • Indiana University Health Hospital โ€” Indianapolis, Indiana
  • Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center โ€” Indianapolis, Indiana
  • IU Health Arnett โ€” Lafayette, Indiana
  • John Hopkins University โ€” Baltimore, Maryland
  • Suburban Hospital โ€” Bethesda, Maryland
  • Reading Hospital โ€” West Reading, Pennsylvania
  • York Cancer Center โ€” York, Pennsylvania
  • University of Texas-San Antonio โ€” San Antonio, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—