Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients with Early-Stage Breast Cancer that was Removed by Surgery

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 11-005483
    • Rochester, Minnesota: 11-005483
    NCT ID: NCT01349322
    Sponsor Protocol Number: RTOG 1005

About this study

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.

PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

DISEASE CHARACTERISTICS:

  • 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 three criteria:
    • pStage I or II breast cancer AND at least one of the following:
      • Age < 50 years or
      • Positive axillary nodes or
      • Lymphovascular space invasion (LVI) or
      • At least 2 close resection margins (> 0 mm to ≤ 2 mm) or
      • One close resection margin and extensive in-situ component (EIC) or
      • Focally positive resection margins or
      • Non-hormone-sensitive breast cancer (estrogen and progesterone receptor negative (ER- and PR-) or
      • Grade III histology or
      • Oncotype recurrence score > 25 or
    • pStage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years or
  • 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
      • Negative SN biopsy after neoadjuvant chemotherapy
    • Axillary node dissection is required following SN biopsy with a minimum total of 6 axillary nodes if any of the following exist:
      • For > 2 positive SN
      • Any positive SN biopsy after neoadjuvant chemotherapy
      • For clinically (by either imaging or examination) T3 disease
      • For extracapsular extension
    • 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 (inspection and palpation of the breasts) and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
    • A mammogram of both right and left breast within only 1 time point of 90 days of the diagnostic biopsy establishing the diagnosis
  • 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
  • Must not be DCIS and ≥ 50 years old
  • Must not be DCIS only (without an invasive component), nuclear grade 1 or 2 and < 50 years old
  • 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
  • Breast implants allowed

PATIENT CHARACTERISTICS:

  • 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 urine or 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 study entry
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Study entry must be within 50 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ivy Petersen, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Ivy Petersen, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20116114

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