Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer

NCT01928589 | Active Not Recruiting DMC

• 1 other identifier: J13104
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Breast Cancer; Adenocarcinoma of the Breast

Keywords

Cyclophosphamide; Doxorubicin; Docetaxel; Carboplatin; Herceptin; Partial Breast Irradiation; Concurrent Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Grade 3 or 4 short-term toxicity

  The primary endpoint will be short term (from baseline to the 6-7 month follow-up) grade 3 or 4 toxicity: confluent moist desquamation, pitting edema, ulceration, hemorrhage or necrosis. Our primary objective is to determine if chemotherapy and PBI can be given concurrently with short term toxicity comparable to standard of care, whole breast radiation (WBR) without chemotherapy, and not inferior to that of PBI plus chemotherapy given sequentially.

  6-7 month follow-up

Secondary Outcomes (4)

• 1st tumor recurrence

  6-7 months

• Long-term grade 3-4 toxicities

  Q6-12M 12-18, 24-30, 36-42, 48-54, 60

• Time to tumor recurrence

  Q6-12M 12-18, 24-30, 36-42, 48-54, 60

• Quantify risks and benefits comparison for each arm

  Q6-12M 12-18, 24-30, 36-42, 48-54, 60

Study Arms (2)

PBI

ACTIVE COMPARATOR

270 cGy (centigray) x 15

Other: PBI with sequential chemotherapy

PBI with chemotherapy

EXPERIMENTAL

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

Other: PBI with concurrent chemotherapy

Interventions

PBI with sequential chemotherapy OTHER

270 cGy x15

Also known as: partial breast irradiation with sequential chemotherapy

PBI

PBI with concurrent chemotherapy OTHER

270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice

Also known as: partial breast irradiation with chemotherapy

PBI with chemotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure. ECOG performance status ≤ 1. Women of child-bearing potential must have a negative (urine or blood) pregnancy test within 6 weeks prior to start of protocol therapy. Women of childbearing potential must also use effective non-hormonal contraception while undergoing radiation treatment and chemotherapy. Note: Women over the age of 70 will not be considered as having child-bearing potential for this study.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Richard Zellars: lead

Study Sites (10)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

IU Health Arnett

Lafayette, Indiana, 47905, United States

Location

John Hopkins University

Baltimore, Maryland, 21218, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

York Cancer Center

York, Pennsylvania, 17403, United States

Location

University of Texas-San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Richard Zellars, MD

  Indiana University School of Medicine, Indiana University Simon Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman of the Department of Radiation Oncology

Model Details: Randomized trial of Partial Breast Irradiation (PBI) with concurrent or sequential chemotherapy

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 26, 2013
• Study Start: January 16, 2014
• Primary Completion: December 12, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (10)