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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 : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Zellars, Indiana University School of Medicine

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.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial of 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: PBI
270 cGy (centigray) x 15
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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 1st tumor recurrence [ Time Frame: 6-7 months ]
    Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study.

  2. Long-term grade 3-4 toxicities [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ]
    Evaluate long term toxicity with concurrent chemotherapy and compare between arms of the study.

  3. Time to tumor recurrence [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ]
    Evaluate and compare Ipsilateral Breast Tumor Recurrence (IBTR), local recurrence, distant recurrence, and disease free survival.

  4. Quantify risks and benefits comparison for each arm [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ]
    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
Criteria

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 and Trastuzamab (TCH) prior to registration. 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 therapy. 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 or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient has other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in sity cervical cancer, or any other cancer from which the patient has been disease-free for less than 5 years.

Patient is pregnant. Patient has a serious medical or physciatric 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.


Information from the National Library of Medicine

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


Contacts
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Contact: Kathryn Lauer 317-962-3172 KLauer@iuhealth.org
Contact: Amy Miller 317-944-1242 amym@iu.edu

Locations
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United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Ruth Chamberlain    202-660-6420    rchamb13@jhmi.edu   
Principal Investigator: Victoria Croog, MD         
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: Amy Miller    317-944-1242    amym@iu.edu   
Principal Investigator: Richard Zellars, MD         
Indiana University Health Melvin and Bren Simon 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: Samuel Durham    765-838-6885    sdurham1@iuhealth.org   
Principal Investigator: Matthew Orton, MD         
United States, Maryland
Suburban Hospital Active, not recruiting
Bethesda, Maryland, United States, 20814
United States, Pennsylvania
Reading Hospital Active, not recruiting
West Reading, Pennsylvania, United States, 19611
York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Debi Oxenberg, RN    717-741-8124    doxenberg@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: Richard Crownover, MD         
Sponsors and Collaborators
Richard Zellars
Investigators
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Principal Investigator: Richard Zellars, MD Indiana University School of Medicine, Indiana University Simon Cancer Center

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Responsible Party: Richard Zellars, Professor and Chairman of the Department of Radiation Oncology, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT01928589     History of Changes
Other Study ID Numbers: J13104
First Posted: August 26, 2013    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by Richard Zellars, Indiana University School of Medicine:
Cyclophosphamide
Doxorubicin
Docetaxel
Carboplatin
Herceptin
Partial Breast Irradiation
Concurrent Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type