Partial Breast Irradiation With Concurrent Chemotherapy for Women With Breast Cancer (PBI 3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01928589
First received: August 21, 2013
Last updated: June 16, 2014
Last verified: June 2014
  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 Trial of Partial Breast Irradiation (PBI) and Sequential vs. Concurrent Chemotherapy in Women With ER Negative Early Stage Breast Cancer (PBI 3.0)"

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

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 and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Patient must be older than 18 years of age
  • Patients must have histologically confirmed (by routine H&E staining) ER-negative invasive adenocarcinoma of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes (pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or sarcomas of the breast cancer are NOT eligible.
  • Patient must have a history and physical within six weeks prior to the start of any protocol therapy.
  • Patient must have had a bilateral mammogram prior to surgery.
  • Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal carcinoma. Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question could not be improved.
  • Patient must have a Medical Oncology consult and be recommended to receive one of the following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin and Trastuzumab (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.
  • Patients must be registered such that patients in the concurrent therapy arm begin their radiation no more than 7 days prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). The concurrent cohort patients must start chemotherapy and radiation less than 10 weeks from the last breast surgical procedure.
  • Patients must NOT have received any neo adjuvant chemotherapy or neo adjuvant hormonal therapy for the current cancer.
  • Patients must have a performance status 0 or 1 by ECOG (Eastern Cooperative Oncology Group) criteria
  • Patients must not have received prior radiation therapy to the involved breast at any time for any reason.
  • Any patient with active local-regional disease prior to registration is not eligible.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years.
  • Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy. Women of child-bearing potential must also have a negative pregnancy test within six weeks prior to start of protocol therapy.
  • Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
  • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
  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: Richard Zellars, MD 410-502-1421 zellari@jhmi.edu
Contact: Shirley DiPasquale, RN 410-614-1598 sdipasq1@jhmi.edu

Locations
United States, Maryland
Anne Arundel Medical Center Not yet recruiting
Annapolis, Maryland, United States, 21401
Contact: Elizabeth Egan, RN    443-481-5811    eegan@aahs.org   
Principal Investigator: Mary Young, MD         
The SKCCC at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Zellars, MD    410-502-1421    zellari@jhmi.edu   
Contact: Shirley DiPasquale, RN    410-614-1598    sdipasq1@jhmi.edu   
Sub-Investigator: Nita Ahuja, MD         
Sub-Investigator: Deborah Armstrong, MD         
Sub-Investigator: Fariba Asrari, MD         
Sub-Investigator: Melissa Camp, MD         
Sub-Investigator: Lana De Souza Lawrence, MD         
Sub-Investigator: Leisha Emens, MD         
Sub-Investigator: John Fetting, MD         
Sub-Investigator: Deborah Frassica, MD         
Sub-Investigator: Mehran Habibi, MD         
Sub-Investigator: Julie Lange, MD         
Sub-Investigator: Todd McNutt, PhD         
Sub-Investigator: Lee Myers, PhD         
Sub-Investigator: Antonio Wolff, MD         
Sub-Investigator: Harvey Ziessman, MD         
Suburban Hospital Not yet recruiting
Bethesda, Maryland, United States, 20814
Contact: Julie Ambrozak, RN    301-896-2016    jambrozak@suburbanhospital.org   
Principal Investigator: Susan Stinson, MD         
Sibley Memorial Hospital Not yet recruiting
District of Columbia, Maryland, United States, 20016
Contact: Amanda Moser    202-660-6420    amoser6@jhmi.edu   
Principal Investigator: Victoria Croog, MD         
United States, Pennsylvania
Reading Hospital Not yet recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Pat Weiser, RN    484-628-8193    patricia.weiser@readinghealth.org   
Principal Investigator: Michael Haas, MD         
York Cancer Center Not yet recruiting
York, Pennsylvania, United States, 17403
Contact: Debi Oxenberg, RN    717-741-8124    doxenberg@wellspan.org   
Principal Investigator: Amit Shah, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Richard Zellars, MD The SKCCC at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01928589     History of Changes
Other Study ID Numbers: J13104, NA_00086037
Study First Received: August 21, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Cyclophosphamide
Doxorubicin
Docetaxel
Carboplatin
Herceptin
Partial Breast Irradiation
Concurrent Chemotherapy

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

ClinicalTrials.gov processed this record on July 31, 2014