Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer
Brief Summary: Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.


Options:
A: Inclusion Criteria:

* Informed consent
* Histologically proven breast carcinoma
* Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition)
* Surgery with clear margins
* Pre-operative medical imaging (at least CT, MRI, and/or PET-scan)

Exclusion Criteria:

* Prior breast or thoracic radiotherapy
* Pregnancy or lactation
* Fertile patients without effective contraception
* Psychiatric or addictive disorders
B: Inclusion Criteria:

* Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with ductal carcinoma in situ \[DCIS\] only); (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy; for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
* Treatment with breast conserving surgery
* Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin; if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a re-excision is strongly encouraged; lobular carcinoma in situ at the final surgical margin will be disregarded
* Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences.
* Female sex.
* Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed)
* If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
* Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of concurrent cytotoxic chemotherapy

Exclusion Criteria:

* Pathologic or clinical evidence for a stage T3 or T4 breast cancer
* Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes
* Clinical or pathologic evidence for distant metastases
* Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
* Current diagnosis of bilateral breast cancer
* History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
* Patients not fluent in English or Spanish (The BCTOS will be available in these two languages)
* Patient is pregnant
C: Inclusion Criteria:

* Required tumor parameters for node positive disease: NOTE: This study will continue to use the American Joint Committee on Cancer (AJCC) 5th edition for TNM classification and staging

  * Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes

    * Node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by hematoxylin and eosin (H\&E)

      * NOTE: Positive nodes refers to H\&E visible nodal metastases; immunohistochemistry (IHC) positive only cells in lymph nodes will not be considered positive nodes
    * One or more positive lymph nodes whose tumors are T1-3, pN1-2, M0 are eligible
    * cN2 disease is not eligible
    * pN2 disease is eligible
    * One positive lymph node by sentinel node biopsy or at least 6 axillary nodes must be examined on axillary node dissection with at least one positive lymph node
    * Metaplastic carcinoma is eligible
  * ER/PgR determination
  * HER-2 positive (pre-entry requirement for registration)

    * FISH must show gene amplification OR
    * IHC assay must show a strong positive (3+) staining score

      * NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification
* Required tumor parameters for high-risk node-negative disease; NOTE: This study will continue to use the AJCC 5th edition for TNM classification and staging

  * Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes

    * Node status may be determined by either axillary node dissection or sentinel node biopsy with H\&E staining; to be considered node negative, either of the following must be true: 1) negative sentinel node biopsy or 2) no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection
    * NOTE: IHC positive only cells in lymph nodes will not be considered positive nodes
    * Tumors \> 2.0 cm (irrespective of hormonal receptor status) or \> 1.0 cm if ER-negative and PR-negative disease
  * ER/PgR determination
  * HER-2 positive (pre-entry requirement for registration)

    * FISH must show gene amplification OR
    * IHC assay must show a strong positive (3+) staining score

      * NOTE: DCIS components should not be counted in the determination of degree of IHC staining or FISH amplification
* =\< 84 days from mastectomy or =\< 84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure; (This timing is per a decision by the Breast Intergroup)
* Surgical resection margins. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy with axillary node dissection

  * Mastectomy: There will be no evidence of gross or microscopic tumor (invasive or DCIS) at the surgical resection margins noted in the final surgery or pathology reports; patients with close margins are eligible
  * Segmental mastectomy (lumpectomy): Margins must be clear of invasive cancer and DCIS
  * Axillary dissection or sentinel node dissection: There will be no gross residual adenopathy
* TAM therapy

  * May have received up to four weeks of TAM therapy, or any other hormonal agent, for this malignancy
  * May have received TAM or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer if lobular carcinoma in situ \[LCIS\]) but must be discontinued before registration on this study
  * May never have received TAM, raloxifene, or any other hormonal agent
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelets (PLT) \>= 100,000/mm\^3
* Total bilirubin =\< 1.5 x upper normal limit (UNL)
* Aspartate aminotransferase (AST) =\< 2.0 x UNL
* Left ventricular ejection fraction (LVEF) within institutional normal range; if LVEF is \> 75%, the investigator should consider performing a second review of the multigated acquisition (MUGA)/echocardiogram or performing a repeat MUGA/echocardiogram prior to registration; such re-reviews or repeat MUGA/echocardiogram are not permitted after registration
* Willingness to discontinue sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to registration and while on study
* Willingness to discontinue any hormonal agent such as raloxifene (Evista) prior to registration and while on study
* Non-breast malignancies that have not recurred within the last 5 years and are deemed to be at low risk for recurrence

EXCEPTIONS: These non-breast malignancies are eligible even if diagnosed =\< 5 years prior to registration:

* Squamous or basal cell carcinoma of the skin that has been effectively treated
* Carcinoma in situ of the cervix that has been treated by surgery only
* Lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast treated by surgery and/or tamoxifen only

  * Patients undergoing breast conservation therapy (i.e., lumpectomy and axillary dissection) must have plans to receive radiation therapy to the breast +/- regional lymphatics following completion of the chemotherapy; for patients treated with mastectomy, the use of radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy; the use of radiation therapy is at the discretion of the investigator for 0-3 positive lymph nodes but, if used, must be started after the completion of chemotherapy
  * Prior to registration, the physician must designate if it is planned for the patient to receive radiation therapy (for adjuvant radiation therapy post-mastectomy or, less commonly, post-conservative therapy but not primary breast radiation as part of breast conserving treatment)
  * Willing and able to sign an informed consent
  * Gene amplified by FISH or strong positivity (3+) by HercepTest on central review; Note: The patient registers based on community HER-2 testing using FISH or IHC, AC chemotherapy is initiated; the tumor block or slides must be received =\< 2 weeks from time of registration to the North Central Cancer Treatment Group (NCCTG) Operations Office for central HER-2 testing

Exclusion Criteria:

* Any of the following:

  * Pregnant women
  * Nursing women
  * Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, intrauterine device \[IUD\], surgical sterilization, or abstinence, etc.); hormonal birth control methods are not permitted
* Locally advanced tumors (classification T4) at diagnosis including tumors fixed to chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
* Prior history of breast cancer, except LCIS
* Bilateral invasive carcinoma, either metachronous or synchronous (EXCEPTION: Patients diagnosed with unilateral invasive carcinoma and metachronous or synchronous DCIS of the contralateral breast treated with mastectomy are eligible)
* Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
* Active, unresolved infection
* Active cardiac disease

  * Any prior myocardial infarction
  * History of documented congestive heart failure (CHF)
  * Current use of digitalis or beta-blockers for CHF
  * Any prior history of arrhythmia or cardiac valvular disease requiring medications or clinically significant
  * Current use of medications for treatment of arrhythmias or angina pectoris
  * Current uncontrolled hypertension (diastolic \> 100 mmHg or systolic \> 200 mmHg)
  * Clinically significant pericardial effusion
* Prior anthracycline or taxane therapy for any malignancy
* Sensitivity to benzyl alcohol
* Neurology/Neuropathy-Sensory \>= grade 2 per the National Cancer Institute's (NCI's) Common Toxicity Criteria Version 2.0; EXCEPTION: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair
D: Inclusion Criteria:

1. The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
2. Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
3. Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.

Exclusion Criteria:

1. Tumour greater than 5 cm in greatest diameter on pathological examination.
2. The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
3. Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
4. Bilateral malignancy of the breast (synchronous or metachronous).
5. More than one primary invasive tumour in the same breast.
6. Previous surgery for breast cancer.
7. Pathological status of axilla is unknown.
8. Status for adjuvant systemic therapy not determined.
9. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
10. For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
11. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
12. Currently pregnant or lactating.
13. Breast deemed too large to permit satisfactory radiation (ie. separation \> 25 cm).
14. Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \\fIin situ\\fR of the cervix which have been effectively treated.
15. Geographic inaccessibility for follow-up.
16. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Answer: A