Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Randomized Comparing Docetaxel, Doxorubicin and Cyclophosphamide (TAC) vs 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of High Risk Operable Breast Cancer Patients With Negative Axillary Lymph Nodes
Brief Summary: This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

* TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
* FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0)

  * Primary tumor at least 2.1 cm in diameter for node-negative disease
  * Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above
* Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR
* Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)

  * Additional axillary nodes may be obtained provided they are also negative for metastasis
* Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy

  * Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed)
* Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed
* Hormone receptor status:

  * Estrogen receptor status positive, negative, or unknown

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No history of myocardial infarction
* No congestive heart failure
* No significant ischemic or valvular heart disease

Other:

* No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for breast cancer

Endocrine therapy:

* Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
* Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed
* No concurrent tamoxifen or other SERMs

Radiotherapy:

* No prior radiotherapy for this malignancy
* At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ

Surgery:

* See Disease Characteristics
* Less than 84 days since prior surgical procedure to adequately treat primary tumor
B: Inclusion Criteria:

* Written informed consent
* Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.
* Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.
* Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.
* Patients without proven metastatic disease.
* Estrogen and progesterone receptors performed on the primary tumour prior to randomization.
* Age between 18 years and 70 years.
* Karnofsky performance status index \> 80 %.
* Adequate hepatic, renal and heart functions.
* Adequate hematology levels.
* Negative pregnancy test

Exclusion Criteria:

* Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
* Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
* Prior radiation therapy for breast cancer.
* Bilateral invasive breast cancer.
* Pregnant, or lactating patients.
* Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .
* Any T4 or N1-3 or M1 breast cancer.
* Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.
* Other serious illness or medical condition
* Past or current history of neoplasm other than breast carcinoma.
* Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.
* Lobular carcinoma in-situ (LCIS) of the breast.
* Chronic treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose
* Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
* Definite contraindications for the use of corticosteroids.
* Concurrent treatment with other experimental drugs.
* Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
* Concurrent treatment with any other anti-cancer therapy.
* Male patients.
C: Inclusion Criteria:

* Histological proven primary breast cancer
* Tumour size \>0.5 cm and \<5 cm (pT1b-pT2, pN0, M0)
* Axillary lymph nodes tumour free (node-negative disease)
* Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre
* Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision.
* Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review.
* HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive).
* No distant metastasis
* Age \>18 years, \<70 years
* Performance status ECOG \<2 (WHO Performance Status 0-1)
* Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%)
* Adequate bone function (neutrophil count \>1.5 x109 /l and platelet count \>100 x109 /l)
* Adequate renal function (serum creatinine \<120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin \<1 x UNL, ASAT or ALAT (SGOT or SGPT) \<2,5 x UNL)
* Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations

Exclusion Criteria:

* Chemotherapy contraindicated
* Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node.
* Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
* Estimated life-expectancy \<10 years (irrespective of breast cancer diagnosis)
* Patient not accessible for treatment and follow up
* Endocrine treatment not according to the latest standard recommendations of the AGO Kommission "Mamma"
* Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required)
* Surgery more than six weeks ago at the start of chemotherapy
* Pre-existing polyneuropathy
* Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Prior chemotherapy or radiotherapy or endocrine therapy
D: Inclusion Criteria:

1. Female patients greater than or equal to18 years of age.
2. Histologically confirmed invasive unilateral breast cancer (regardless of

   histology).
3. Early-stage breast cancer, defined as:

   * Node-positive disease: \>0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR
   * Node-negative, with primary tumor \>1.0 cm (T1c-T3).
4. Definitive loco-regional surgery must have been completed as specified

   below:
   * Patients must have undergone either breast conservation surgery

     (i.e., lumpectomy) or total mastectomy.
   * Surgical margins of the resected section must be histologically free of

   invasive adenocarcinoma and ductal carcinoma in situ.
   * Surgical margins involved with lobular carcinoma in situ (LCIS) will not

   be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection.
   * Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below:

   Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection.
5. Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above.
6. Patients with synchronous bilateral cancers are eligible only if:

   * All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2-.
   * Eligibility based on the highest stage grouping.
7. HER2 negative tumors. HER2 negativity must be confirmed by one of the

   following:
   * FISH-negative (FISH ratio \<2.2), or
   * IHC 0-1+, or
   * IHC 2-3+ AND FISH-negative (FISH ratio \<2.2).
8. Estrogen receptor negative (\<10% staining by IHC for estrogen receptor).
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
10. Patient must be \<= 84 days from having completed definitive primary breast surgery (either lumpectomy or mastectomy).
11. MammoSite brachytherapy radiation is acceptable if it is performed

    immediately following surgery and prior to chemotherapy. It is recommended that chemotherapy be started no earlier than 2 weeks following the removal of the MammoSite balloon catheter.
12. Adequate hematologic function, defined by:

    * Absolute neutrophil count (ANC) \>1500/mm3
    * Platelet count \>=100,000/mm3
    * Hemoglobin \>9 g/dL
13. Adequate liver function, defined by:

    * AST and ALT \<=2.5 x the upper limit of normal (ULN)
    * Total bilirubin \<=1.5 x ULN (unless the patient has grade 1 bilirubin

    elevation due to Gilbert's disease or a similar syndrome involving slow

    conjugation of bilirubin).
14. Adequate renal function, defined by:

    * Serum creatinine \<=1.5 x ULN
15. Complete staging work-up \<=12 weeks prior to initiation of study treatment

    with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), and either a positron emission tomography (PET) scan or a bone scan.
16. Adequate cardiac function, defined by a left ventricular ejection fraction

    (LVEF) value of \>50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).
17. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery (i.e., sentinel node biopsy, port-acath (placement); at least 3 weeks must have elapsed from the time of a major surgery (i.e., lumpectomy, partial or total mastectomy, axillary lymph node dissection, breast reconstruction procedure).
18. Patients with previous history of invasive cancers (including breast cancer)

    are eligible if definitive treatment was completed more than 5 years prior to

    initiating current study treatment, and there is no evidence of recurrent disease.
19. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
20. Patient must be accessible for treatment and follow-up.
21. Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.
22. All patients must be able to understand the investigational nature of the

study and give written informed consent prior to study entry.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. History of previous diagnosis of invasive breast cancer (unless treated \>5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
3. Any evidence or suspicion of metastatic disease other than ipsilateral

   axillary lymph nodes.
4. Any tumor \>=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer).
5. Previous anthracycline chemotherapy.
6. Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of

   study treatment until the end of treatment with ixabepilone.
7. Previous treatment for this breast cancer (including neoadjuvant

   chemotherapy).
8. Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer).
9. Peripheral neuropathy of \> grade 1 per NCI CTCAE v3.0.
10. Cardiac disease, including: congestive heart failure (CHF) \> Class II per

    New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
11. History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or

    a drug formulated in CremophorEL such as paclitaxel.
12. Use of any investigational agent within 30 days of administration of the first dose of study drug.
13. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
14. Concurrent severe, uncontrolled infection or intercurrent illness including,

    but not limited to, ongoing or active infection, or psychiatric illness/social

    situations that would limit compliance with study requirements.
15. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
16. Inability to comply with study and/or follow-up procedures.

Answer: B