Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer
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ClinicalTrials.gov Identifier: NCT01928589 |
Recruitment Status :
Recruiting
First Posted : August 26, 2013
Last Update Posted : August 26, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Adenocarcinoma of the Breast | Radiation: PBI with sequential chemotherapy Other: PBI with concurrent chemotherapy | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 159 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized trial of Partial Breast Irradiation (PBI) with concurrent or sequential chemotherapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women With Early Stage Breast Cancer (PBI 3.0) |
Study Start Date : | September 2013 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | January 2026 |

Arm | Intervention/treatment |
---|---|
Active Comparator: PBI
270 cGy (centigray) x 15
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Radiation: PBI with sequential chemotherapy
270 cGy x15
Other Name: partial breast irradiation with sequential chemotherapy |
Experimental: PBI with chemotherapy
270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice
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Other: PBI with concurrent chemotherapy
270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice
Other Name: partial breast irradiation with chemotherapy |
- Grade 3 or 4 short-term toxicity [ Time Frame: 6-7 month follow-up ]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.
- 1st tumor recurrence [ Time Frame: 6-7 months ]Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study.
- Long-term grade 3-4 toxicities [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60 ]Evaluate long term skin toxicity with concurrent chemotherapy and compare between arms of the study.
- Time to tumor recurrence [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60 ]Evaluate and compare Ipsilateral Breast Tumor Recurrence (IBTR), local recurrence, distant recurrence, and disease free survival.
- Quantify risks and benefits comparison for each arm [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60 ]Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC); or Taxotere, Carboplatin withTrastuzamab (TCH) prior to registration; or Paclitaxel and Trastuzumab. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the Medical Oncologist. Other primary regimens are possible but the PI must be notified prior to enrollment. 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.
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928589
Contact: Nikki Barrow | 317-944-0260 | nrbarrow@iu.edu | |
Contact: Kathryn Lauer | 317-962-3172 | KLauer@iuhealth.org |
United States, District of Columbia | |
Sibley Memorial Hospital | Active, not recruiting |
Washington, District of Columbia, United States, 20016 | |
United States, Indiana | |
Parkview Regional Medical Center | Recruiting |
Fort Wayne, Indiana, United States, 46845 | |
Contact: Karen Kreiger 260-266-6622 karen.kreiger@parkview.com | |
Contact: Angel Hamman 260-266-7745 angela.hamman@parkview.com | |
Principal Investigator: Wesley Russell, MD | |
Indiana University Health Hospital | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Lauren Irwin 317-944-0310 lauirwin@iu.edu | |
Contact: Nikki Barrow 317-944-0310 nrbarrow@iu.edu | |
Principal Investigator: Richard Zellars, MD | |
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Kathryn Lauer 317-962-3172 KLauer@iuhealth.org | |
Principal Investigator: Richard Zellars, MD | |
IU Health Arnett | Recruiting |
Lafayette, Indiana, United States, 47905 | |
Contact: Julia Keenoy 765-838-6848 jkeenoy@iuhealth.org | |
Principal Investigator: Matthew Orton, MD | |
United States, Maryland | |
John Hopkins University | Active, not recruiting |
Baltimore, Maryland, United States, 21218 | |
Suburban Hospital | Active, not recruiting |
Bethesda, Maryland, United States, 20814 | |
United States, Pennsylvania | |
Reading Hospital | Completed |
West Reading, Pennsylvania, United States, 19611 | |
York Cancer Center | Recruiting |
York, Pennsylvania, United States, 17403 | |
Contact: Erica Zahos 717-741-8124 ezahos@wellspan.org | |
Principal Investigator: Amit Shah, MD | |
United States, Texas | |
University of Texas-San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Carol Jenkins 210-450-5924 jenkinsca@uthscsa.edu | |
Principal Investigator: Mohamad Fakhreddine, MD |
Principal Investigator: | Richard Zellars, MD | Indiana University School of Medicine, Indiana University Simon Comprehensive Cancer Center |
Responsible Party: | Richard Zellars, Professor and Chairman of the Department of Radiation Oncology, Indiana University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01928589 |
Other Study ID Numbers: |
J13104 |
First Posted: | August 26, 2013 Key Record Dates |
Last Update Posted: | August 26, 2022 |
Last Verified: | August 2022 |
Cyclophosphamide Doxorubicin Docetaxel Carboplatin |
Herceptin Partial Breast Irradiation Concurrent Chemotherapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |