Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

RTOG 1005 Phase III Randomized Study of Accelerated Hypofractionated Whole-Breast Irradiation and Concurrent Boost Versus Standard Whole-Breast Irradiation and Sequential Boost in Patients With Early-Stage Breast Cancer After Lumpectomy

Purpose

To determine whether an accelerated course of hypofractionated whole-breast irradiation (WBI) including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients

Patient Inclusion Criteria:

  • Age ≥ 18 years
  • Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole-breast irradiation (WBI) with boost without regional nodal irradiation planned
  • Must meet one of the following criteria:
  • Stage I or II breast cancer AND at least one of the following:
    1. Age < 50 years
    2. Positive axillary nodes
    3. Lymphovascular space invasion (LVI)
    4. At least 2 close resection margins (> 0 mm to ≤ 2 mm)
    5. One close resection margin and extensive in-situ component (EIC)
    6. Focally positive resection margins
    7. Non-hormone-sensitive breast cancer (estrogen-receptor negative (ER-) and progesterone-receptor (PR-) negative)
    8. Grade III histology
    9. Breast implants allowed
    10. Oncotype recurrence score > 25
    11. Stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years
    12. No DCIS and age > 50 years
    13. No DCIS and age < 50 years and nuclear grade 1 or 2
    14. Resected by lumpectomy after neoadjuvant systemic therapy
    15. If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins

  • Breast-conserving surgery with margins defined as follows:
    1. Negative margins defined as no tumor at the resected specimen edge

  • Close resection margins > 0 mm to ≤ 2 mm as follows:
    1. One close resection margin and EIC
    2. Two or more close resection margins
    3. A focally positive resection margin

  • Allowable options for mandatory axillary staging include:
    1. Sentinel node biopsy alone (if sentinel node is negative, pN0, pN0[IHC-,+])

  • Sentinel node biopsy alone, or followed by axillary node dissection, for clinically node-negative patients as described below:
    1. Microscopic sentinel node (SN) positive (pN1mic)
    2. One or two SNs positive (pN1) without extracapsular extension
    3. Negative SN biopsy after neoadjuvant chemotherapy

  • SN biopsy followed by axillary dissection with a minimum total of 6 axillary nodes if any of the following exist:
    1. > 2 positive SN
    2. Solitary SN that is positive without other sentinel nodes dissected
    3. Clinically (by either imaging or examination) T3 disease
    4. Presence of one or more positive SNs with extracapsular extension, clinically node-positive disease, or LVI in the primary tumor
    5. Axillary dissection alone (with a minimum of 6 axillary nodes)

  • CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatment planning
  • Must be able to delineate on CT scan the extent of the target lumpectomy cavity for boost (placement of surgical clips to assist in treatment planning of the boost is strongly recommended)

  • No clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
    1. History/physical examination, including breast exam (inspection and palpation of the breasts) and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
    2. Bilateral mammogram within 90 days prior to study entry
    3. Bilateral or right and left mammography within 90 days prior to neoadjuvant chemotherapy, diagnostic biopsy establishing diagnosis, or last surgery (breast or axilla)

Patient Exclusion Criteria:

  • None of the following allowed:
    1. No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
    2. No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast cancer
    3. Must not have two or more breast cancers that are not resectable through a single lumpectomy incision
    4. No invasive breast cancer and low-risk (see low risk features below) for 5-year in-breast recurrence after lumpectomy with negative margins, defined as:
      1. ≥ 70 years old, T1, N0, ER/PR+
      2. > 50 years old, T1, N0, grade 1-2 breast cancer, ER/PR+

  • No suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
  • No non-epithelial breast malignancies such as sarcoma or lymphoma
  • No Paget disease of the nipple
  • No male breast cancer

To Learn more
Phase

3

Gender

Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

CW ID: 183099

Date Last Changed: July 17, 2013


DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.