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SCCA Breast Cancer Clinical Trials

Whole Breast Irradiation with Hypofractionation versus standard Whole Breast Irradiation (RTOG 1005)
A Phase III clinical trial of Accelerated Whole Breast Irradiation with Hypofractionation plus concurrent boost versus standard Whole Breast Irradiation plus sequential boost for early-stage breast cancer.
Status Conditions Phase Study ID
Closed Breast cancer Phase III RTOG 1005
NCT01349322
Summary

The current study proposes to establish a hypofractionation schedule (with a concurrent boost) that delivers a dose in only 3 weeks that can be applied to a broader patient population than enrolled in the existing hypofractionation studies (high-risk, large breasted, and those requiring chemotherapy) seen routinely in everyday practice. Patient inclusion criteria will be defined to include patients at higher than average risk for local recurrence who could most benefit from the addition of a tumor bed boost - age < 50 years (even with DCIS), node positive breast cancer, lymphovascular space invasion, presence of an EIC with close (< 2mm) resection margins, focally positive margins, and/or non-hormone sensitive breast cancer. If the proposed regimen were proven to provide equivalent low control even in these higher-risk patients, the impact on the treatment of the majority of breast cancer patients would be practice changing.


Investigator
George Laramore, MD
Location    
Seattle Cancer Care Alliance 800-804-8824 Refer Patient
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)

PATIENT CHARACTERISTICS:

PRIOR CONCURRENT THERAPY:

  • 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:

      • Age < 50 years
      • Positive axillary nodes
      • Lymphovascular space invasion (LVI)
      • More than 2 close resection margins (> 0 mm to ≤ 2 mm)
      • One close resection margin and extensive in-situ component (EIC)
      • Focally positive resection margins
      • Non-hormone-sensitive breast cancer (estrogen-receptor negative (ER-) and progesterone-receptor (PR-) negative)
      • Grade III histology
      • Oncotype recurrence score > 25
    • Stage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years

      • No DCIS and age > 50 years
      • No DCIS and age < 50 years and nuclear grade 1 or 2
  • Resected by lumpectomy after neoadjuvant systemic therapy
  • 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:

    • Negative margins defined as no tumor at the resected specimen edge
    • Close resection margins > 0 mm to ≤ 2 mm as follows:

      • One close resection margin and EIC
      • Two or more close resection margins
    • A focally positive resection margin
  • Allowable options for mandatory axillary staging include:

    • 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:

      • Microscopic sentinel node (SN) positive (pN1mic)
      • One or two SNs positive (pN1) without extracapsular extension AND pT1 or pT2 AND no LVI AND at least one additional negative SN
    • SN biopsy followed by axillary dissection with a minimum total of 6 axillary nodes if any of the following exist:

      • > 2 positive SN
      • Solitary SN that is positive without other sentinel nodes dissected
      • Clinically (by either imaging or examination) T3 disease
      • Presence of one or more positive SNs with extracapsular extension, clinically node-positive disease, or LVI in the primary tumor
    • 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:

    • History/physical examination, including breast exam and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
    • Bilateral mammogram within 6 months prior to study entry
  • No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
  • No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast cancer
  • Must not have two or more breast cancers that are not resectable through a single lumpectomy incision
  • 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:

    • ≥ 70 years old, T1, N0, ER/PR+
    • > 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
    • ANC ≥ 1,800/mm³
    • Platelet count ≥ 75,000/mm³
    • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
    • Negative serum pregnancy test within 14 days of study entry
    • Women of childbearing potential must not be pregnant or nursing and willing to use medically acceptable form of contraception during radiotherapy
    • No prior invasive non-breast malignancy (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to registration
    • No severely active co-morbidity, defined as follows:

      • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
      • Transmural myocardial infarction within the past 6 months
      • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
      • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
      • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
      • Acquired Immune-Deficiency Syndrome (AIDS) based upon current CDC definition

        • HIV testing is not required for entry into this protocol
    • No active systemic lupus, erythematosus, or any history of scleroderma or dermatomyositis with active rash
    • Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
    • See Disease Characteristics
    • Study entry must be within 42 days of last breast/axillary surgery and/or last chemotherapy
    • No treatment plan that includes regional node radiotherapy
    • No prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
    • No intention to administer concurrent chemotherapy for current breast cancer
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.