Statement: Female patients over 6 months pregnant cannot take part in either the secondary trial or the primary trial
Primary_evidence: Inclusion Criteria:   All subjects must be female.   Postmenopausal status, defined as any one of the following criteria:   Documented history of bilateral oophorectomy.   Age 60 years or more.   Age 45 to 59 and satisfying one or more of the following criteria:   Amenorrhea for at least 12 months and intact uterus.   Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including: patients who have had a hysterectomy and patients who have received hormone replacement.   Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.   Estrogen receptor and/or progesterone receptor positive disease.   Patients must not have received any prior treatment for current or newly diagnosed breast cancer.   Patients must have not received previous treatment with any of the study medications or similar drugs.   No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.   WHO performance status of 0, 1, or 2.   Adequate organ function defined as follows:   Adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal.   Adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal.   Adequate bone marrow function, defined as a WBC greater than 3.0 ml, PLT greater than 75,000/ul, Hb greater than 9 gm/l.   Willing to undergo breast core biopsies as required by the study protocol. - Ability to understand and sign a written informed consent for participation in the trial.   Life expectancy of at least 1 year. Exclusion Criteria:   Premenopausal status.   Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ.   Patients with brain metastasis.   WHO performance status of 3 or 4.   Is judged by the investigator, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.   Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial. - Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.   Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.   Platelet count less than 75,000.   In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.   History of hypersensitivity to castor oil.   Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) - Patients with recurrent breast cancer.   Patients with contralateral second primary breast cancers are eligible.
Secondary_evidence: Inclusion Criteria:   To be included in this study, you must meet the following criteria:   Metastatic breast cancer confirmed by biopsy   No more than one prior chemotherapy regimen for metastatic breast cancer   Able to perform activities of daily living with minimal assistance   Adequate bone marrow, liver and kidney function   Age 18 years or older   Give written informed consent Exclusion Criteria:   You cannot participate in this study if any of the following apply to you:   Moderate to severe peripheral neuropathy   Uncontrolled blood pressure or uncontrolled heart beat irregularities   Diabetes Mellitus with fasting blood sugar greater than 200 mg %   Significant heart disease within the prior 6 months   Severe or uncontrolled medical disease   Active uncontrolled infection   Known chronic liver disease   Known diagnosis of HIV infection   Pregnant or breast feeding females   Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.