Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.


Options:
A: Inclusion Criteria:

* Patients must have estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast with measurable recurrent or metastatic carcinoma of the breast
* Baseline measurements and evaluations of involved sites should be performed as close as possible to study entry, but must be within 4 weeks prior to randomization
* Patients with available tissue blocks from either the primary or metastatic site must submit the tissue for EGFR analysis
* All patients must be postmenopausal females defined by:

  * Prior bilateral oophorectomy or bilateral ovarian irradiation
  * No menstrual period for 12 months or longer. If age 55 years or less and on tamoxifen within the prior 6 months, must have an estradiol level in the postmenopausal range
* Patients must not have had more than 2 prior chemotherapy regimens for metastatic disease and no chemotherapy within 3 weeks prior to randomization; no concurrent chemotherapy is allowed while on protocol therapy
* Patients must not have prior hormonal therapy for metastatic disease; no prior therapy in the adjuvant setting with an estrogen receptor down-regulator (e.g. fulvestrant) or an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane, aminoglutethamide); non-protocol concurrent hormonal therapy is not allowed
* Patients must not have had prior therapy with agents that target EGFR
* Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed; patients must not receive trastuzumab (Herceptin) within 3 weeks prior to randomization
* Patients must have ECOG performance status of 0, 1, or 2
* Neutrophils \>= 1500/mm\^3
* Platelets \>= 100,000/mm\^3
* Bilirubin =\< 1.25 x upper limit of normal
* SGPT (ALT) and SGOT (AST) =\< 2.5 x upper limit of normal if no demonstrable liver metastases or =\< 5 times upper limit of normal in the presence of liver metastases
* Calculated creatinine clearance \>= 30ml/min
* INR, PT and PTT within normal range
* Patients must not be receiving therapy with anticoagulants or have other contraindication to i.m. injections
* Patients must not have a history of central nervous system metastasis
* Patients may receive concurrent radiation therapy to painful sites of boney disease or areas of impending fracture as long as the radiation therapy is initiated prior to study entry and sites of measurable disease outside the radiation therapy port are available to follow; patient who have received prior radiation therapy must have recovered from toxicity of the prior radiation therapy
* Patients must not take the following medications that may alter ZD1839 pharmacokinetics while enrolled in this trial: phenytoin, carbamazapine, phenobarbitol, rifampicin, and St. John's Wort, oxcarbazepine, rifapentine, modafinil, and griseofulvin
* Patients age =\< 55 years must not be receiving LHRH agonists or antagonists within 3 months prior to randomization
* Patients who have an ocular inflammation or infection should be fully treated before entry into the trial; patients with a neuropathic keratopathy or diabetes or those with anterior basement membrane disease must be advised of the need for frequent opthalmalogic exams
* Patients who continue to wear contact lenses must be advised that they have an increased risk of ocular events; the decision to wear contact lenses should be discussed with the patient's treating oncologist and ophthalmologist
* Patients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities
* Patients must be disease-free of prior invasive malignancies for \> 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
B: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer meeting 1 of the following criteria:

  * Metastatic disease (M1)
  * Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease)
* Measurable or nonmeasurable disease
* No known brain or CNS metastases
* Hormone receptor status:

  * Estrogen-receptor positive\* AND/OR
  * Progesterone-receptor positive\* NOTE: \*Positivity defined as estrogen binding of \> 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry

PATIENT CHARACTERISTICS:

Age

* Not specified

Sex

* Female

Menopausal status

* Postmenopausal, as defined by 1 of the following:

  * Prior bilateral oophorectomy
  * More than 12 months since last menstrual period with no prior hysterectomy
  * At least 55 years of age with prior hysterectomy
  * Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause

Performance status

* Zubrod 0-2

Life expectancy

* Not specified

Hematopoietic

* No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)

Hepatic

* INR ≤ 1.6

Renal

* Not specified

Other

* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior immunotherapy for recurrent or metastatic disease

Chemotherapy

* No prior chemotherapy for recurrent or metastatic disease
* More than 12 months since prior adjuvant or neoadjuvant chemotherapy
* No concurrent chemotherapy for malignancy

Endocrine therapy

* Prior adjuvant hormonal therapy allowed
* At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues

  * Menstrual periods must not have resumed since LHRH therapy
* More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)
* More than 12 months since prior fulvestrant
* No prior hormonal therapy for recurrent or metastatic disease
* No other concurrent hormonal therapy for malignancy
* No concurrent hormone replacement therapy

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No long-term anticoagulant therapy (except antiplatelet therapy)
C: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the breast

  * Locally advanced or metastatic disease
* Metastatic disease must be measurable or evaluable

  * Patients with bone only metastases are eligible provided there is an evaluable site of bone metastasis that can be followed by x-ray, MRI, or CT scan
* Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase inhibitor (NSAI)\*, meeting either of the following criteria:

  * NSAI given as adjuvant therapy that lasted ≥ 12 months
  * Achieved an objective complete response, partial response, or stable disease that lasted ≥ 6 months after prior first-line therapy with NSAI for locally advanced or metastatic disease

    * Chemotherapy as part of the first-line therapy given before initiation of NSAI allowed NOTE: \*Patients are required to continue to take NSAI until beginning of study treatment.
* No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse hepatic involvement)
* Hormone receptor status:

  * Estrogen receptor (ER) and/or progesterone receptor positive tumor
  * No ER-unknown disease

PATIENT CHARACTERISTICS:

Sex

* Female

Menopausal status

* Postmenopausal, as defined by 1 of the following criteria:

  * Age 60 and over
  * Age 45 to 59 AND ≥ 12 months since last menstrual period with no prior hysterectomy
  * Any age with prior bilateral oophorectomy

Performance status

* WHO 0-2

Life expectancy

* More than 3 months

Hematopoietic

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

  * No thrombocytopenia
* Hemoglobin ≥ 10 g/dL

Hepatic

* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN (unless due to bone metastases)
* No liver disease

Renal

* Creatinine \< 1.97 mg/dL

Other

* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Chemotherapy

* See Disease Characteristics
* Prior neoadjuvant or adjuvant chemotherapy allowed

Endocrine therapy

* See Disease Characteristics
* Prior tamoxifen as neoadjuvant or adjuvant therapy allowed
* No systemic corticosteroids that lasted \> 15 days within the past 4 weeks

Other

* More than 4 weeks since prior investigational drugs
* Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy has been established for ≥ 6 months

  * Concurrent initiation of bisphosphonate allowed provided patient has soft tissue or visceral metastases as the measurable or evaluable target lesion
* No concurrent anticoagulant therapy
* No concurrent unlicensed noncancer investigational agents
D: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast.
* Metastatic disease must be measurable or evaluable
* Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
* NSAI given as adjuvant therapy that lasted ≥ 12 months OR
* Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
* Female postmenopausal patients

Exclusion Criteria:

* Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
* Prescribed Tamoxifen for metastatic disease
* Rapidly progressive visceral disease
* Patients with malignancies within the last 5 years.

Answer: B