This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
• The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information.
The patient must have an ECOG performance status of 0 or 1.
The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.)
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
• Definitive clinical or radiologic evidence of metastatic disease.
pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
Patient had a mastectomy.
Parallel
Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Other interventionPost lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins). Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
DrugEndocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s).
Time to invasive or noninvasive IBTR.
Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)
Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures.
Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)
Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence.
Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free
Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.
Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)
Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer).
Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)
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NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
