Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase III trial studies standard or comprehensive radiation therapy in
treating patients with early-stage breast cancer who have undergone surgery. Radiation
therapy uses high-energy x rays to kill tumor cells. It is not yet known whether
comprehensive radiation therapy is more effective than standard radiation therapy in treating
patients with breast cancer
Phase
N/A
Funding Agency/Sponsor
National Cooperative Group
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- The patient must have signed and dated an Institutional Review Board (IRB)-approved
consent form that conforms to federal and institutional guidelines
- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1
- Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before
neoadjuvant therapy); clinical axillary nodal involvement can be assessed by
palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission
tomography (PET) scan, or PET/CT scan
- Patient must have had pathologic confirmation of axillary nodal involvement at
presentation (before neoadjuvant therapy) based on either a positive fine needle
aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy
(demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be
performed either by palpation or by image guidance; documentation of axillary nodal
positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
- Patients must have had estrogen receptor (ER) analysis performed on the primary breast
tumor before neoadjuvant therapy according to current American Society of Clinical
Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for
hormone receptor testing; if negative for ER, assessment of progesterone receptor
(PgR) must also be performed according to current ASCO/CAP guideline recommendations
for hormone receptor testing (http://www.asco.org)
- Patients must have had HER2 testing performed on the primary breast tumor before
neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations
for human epidermal growth factor receptor 2 testing in Breast Cancer
(http://www.asco.org); patients who have a primary tumor that is either HER2-positive
or HER2-negative are eligible
- Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy
consisting of an anthracycline and/or taxane-based regimen
- For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of
intended chemotherapy may be administered but must be completed before randomization;
(if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose
and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note:
It is preferred that all intended chemotherapy be administered in the neoadjuvant
setting
- Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy
(either with all or with a portion of the neoadjuvant chemotherapy regimen), unless
medically contraindicated
- At the time of definitive surgery, all removed axillary nodes must be histologically
free from cancer; acceptable procedures for assessment of axillary nodal status at the
time of surgery include:
- Axillary node dissection
- Sentinel node biopsy alone or
- Sentinel node biopsy followed by axillary node dissection
- Note: Patients are eligible whether there is residual invasive carcinoma in the
surgical breast specimen or whether there is evidence of pathologic complete
response; patients who are found to be pathologically node-positive at the time
of surgery, based on sentinel node biopsy alone, are candidates for A011202, a
study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202
is open at the investigator's institution, patients should be approached about
participating in the A011202 study
- Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note:
Postneoadjuvant therapy is designated with a "yp" prefix.)
- Patient who have undergone either a total mastectomy or a lumpectomy are eligible
- For patients who undergo lumpectomy, the margins of the resected specimen or
re-excision must be histologically free of invasive tumor and DCIS as determined by
the local pathologist; additional operative procedures may be performed to obtain
clear margins; if tumor is still present at the resected margin after re-excision(s),
the patient must undergo total mastectomy to be eligible; (patients with margins
positive for lobular carcinoma in situ [LCIS] are eligible without additional
resection)
- For patients who undergo mastectomy, the margins must be histologically free of
residual (microscopic or gross) tumor
- The interval between the last surgery for breast cancer (including re-excision of
margins) and randomization must be no more than 70 days; also, if adjuvant
chemotherapy was administered, the interval between the last chemotherapy treatment
and randomization must be no more than 70 days
- The patient must have recovered from surgery with the incision completely healed and
no signs of infection
- If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may
interfere with delivery of radiation therapy should have resolved
Exclusion Criteria:
- Definitive clinical or radiologic evidence of metastatic disease
- T4 tumors including inflammatory breast cancer
- Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node
biopsy alone
- N2 or N3 disease detected clinically or by imaging
- Patients with histologically positive axillary nodes post neoadjuvant therapy
- Patients with microscopic positive margins after definitive surgery
- Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with
synchronous and/or previous contralateral LCIS are eligible)
- Any prior history, not including the index cancer, of ipsilateral invasive breast
cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous
or previous ipsilateral LCIS are eligible)
- History of non-breast malignancies (except for in situ cancers treated only by local
excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
to randomization
- Any radiation therapy for the currently diagnosed breast cancer prior to randomization
- Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone
replacement therapy; patients are eligible if these medications are discontinued prior
to randomization
- Prior breast or thoracic radiation therapy (RT) for any condition
- Active collagen vascular disease, specifically dermatomyositis with a creatinine
phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus
erythematosus, or scleroderma
- Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be
performed within 2 weeks prior to randomization according to institutional standards
for women of childbearing potential)
- Other non-malignant systemic disease that would preclude the patient from receiving
study treatment or would prevent required follow-up
- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements