A trial investigating different treatment plans of the medication nab-Paclitaxel, a chemotherapeutic agent in patients with breast cancer that has spread to other parts of the body.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 258

Inclusion Criteria

• Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
• Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
• Female aged 18 years or older.
• Life expectancy > 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
• If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
• Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
• Normal hematologic status. Must meet all criteria: absolute neutrophil count = 1500/mm3 (1.5 x 109/L), platelets = 100 x 109/L and hemoglobin = 9 g/dL (= 90 g/L)).
• Normal renal function (serum creatinine = 1.5 ULN or calculated creatinine clearance = 50mL/min according to the Cockcroft and Gault formula).
• Normal liver function. Must meet all criteria: ALT (SGPT) and AST (SGOT) = 3 × upper limit of normal (ULN) (without liver metastases; total bilirubin = 1.5 mg/dL;. Exceptions: If the patient has liver metastases, ALT (SGPT) and AST (SGOT) must be = 5 × ULN; total bilirubin = 1.5 mg/dL. If the patient has Gilbert’s disease higher bilirubin is acceptable (= 3 mg/dL)
• Normal cardiac function defined as left ventricular ejection fraction within the institutional range of normal as measured by MUGA or echocardiogram.
• Women of child bearing potential must have documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug. If for any reason the administration of first dose of trial treatment is not within 2 weeks of the pregnancy test, a second pregnancy test should be performed within two weeks of day 1 of cycle 1.
• Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
• Completed baseline Quality of Life Form.
• The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
• Availability of an FFPE block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
• Written consent to pathology material submission, indicating the patient has been informed of and agrees to tissue material use, transfer and handling, must be signed and dated by the patient and the Investigator prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 212
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

• Any prior chemotherapy for metastatic breast cancer.
• Presence of CNS metastasis.
• Peripheral neuropathy grade 2 or higher (CTCAE version 4).
• Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
• Pregnant or lactating.
• Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
• Any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
• Contraindications or known hypersensitivity to the study medication or excipients.
• The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
• Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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