Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer (PBI 3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Richard Zellars, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT01928589
First received: August 21, 2013
Last updated: August 15, 2016
Last verified: August 2016
  Purpose

Women with ER negative breast cancer have a higher risk of the cancer returning in the breast after whole or partial breast radiation than women with ER positive breast cancer. In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. This combined treatment was safe and women with ER negative breast cancer did just as well as women with ER positive cancer.

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 Intervention Phase
Breast Cancer
Adenocarcinoma of the Breast
Radiation: PBI
Other: PBI with chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Grade 3 or 4 short-term toxicity [ Time Frame: 6-7 month follow-up ] [ Designated as safety issue: Yes ]
    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:
  • 1st tumor recurrence [ Time Frame: 6-7 months ] [ Designated as safety issue: No ]
    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, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: Yes ]
    Evaluate long term 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, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: No ]
    Evaluate and compare Ipsilateral Breast Tumor Recurrence (IBTR), local recurrence, distant recurrence, and disease free survival.

  • Quality of Life assessment [ Time Frame: Q6-12M 12-18, 24-30, 36-42, 48-54, 60-66, 72-78, 84-90, 96-108, 120 ] [ Designated as safety issue: No ]
    Evaluate and compare quality of life.

  • 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 ] [ Designated as safety issue: Yes ]
    Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.


Estimated Enrollment: 108
Study Start Date: September 2013
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PBI
270 cGy (centigray) x 15
Radiation: PBI
270 cGy x15
Other Name: partial breast irradiation
Experimental: PBI with chemotherapy
270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice
Other: PBI with chemotherapy
270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice
Other Name: partial breast irradiation with chemotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928589

Contacts
Contact: Jill Deluca 317-944-1189 jdelucca@iupui.edu

Locations
United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jill Deluca    317-944-1189    jdelucca@iupui.edu   
Principal Investigator: Richard Zellars, MD         
Indiana University Health Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jill Deluca    317-944-1189    jdelucca@iupui.edu   
Principal Investigator: Richard Zellars, MD         
United States, Maryland
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Julie Ambrozak, RN    301-896-2016    jambrozak@suburbanhospital.org   
Principal Investigator: Susan Stinson, MD         
Sibley Memorial Hospital Recruiting
District of Columbia, Maryland, United States, 20016
Contact: Ruth Chamberlain    202-660-6420    rchamb13@jhmi.edu   
Principal Investigator: Victoria Croog, MD         
United States, Pennsylvania
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Leah Ernst    484-628-8194    leah.ernst2@readinghealth.org   
Principal Investigator: Michael Haas, MD         
York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Debi Oxenberg, RN    717-741-8124    doxenberg@wellspan.org   
Principal Investigator: Amit Shah, MD         
Sponsors and Collaborators
Richard Zellars
Investigators
Principal Investigator: Richard Zellars, MD Indiana University School of Medicine, Indiana University Simon Cancer Center
  More Information

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 
Study First Received: August 21, 2013
Last Updated: August 15, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Indiana University:
Cyclophosphamide
Doxorubicin
Docetaxel
Carboplatin
Herceptin
Partial Breast Irradiation
Concurrent Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 24, 2016