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

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

Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women With Early Stage Breast Cancer (PBI 3.0)

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: Review the eligibility criteria below.

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

Age range: 18 Years to 100 Years

๐Ÿงช Interventions in This Study

  • PBI with sequential chemotherapy (OTHER)
  • PBI with concurrent chemotherapy (OTHER)

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

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.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—