Clinical trial NCT01009983 (phase 2, status: terminated)
Conditions: breast cancer, recurrent breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: paclitaxel, carboplatin
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion

          -  Pathologically confirmed invasive breast cancer with ER < 10%, PR < 10%, by IHC, HER2
             1+ or 0 or FISH negative

          -  Measurable (>= 1 cm) or assessable disease detectable by imagining or physical exam

          -  Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan

          -  Only one or no prior therapy for metastatic or recurrent breast cancer is allowed

          -  Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should
             elapse prior to study enrollment

          -  Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior
             to study enrollment

          -  Prior therapy with bevacizumab is permitted but at least 28 days should elapse from
             the last bevacizumab treatment prior to study enrollment

          -  ECOG PS or 0-1

          -  Signed protocol specific informed consent prior to registration

          -  Life expectancy greater than 3 months

          -  Please contact study investigator and/or consult the protocol document for specific
             laboratory criteria

          -  Tissue block available from primary breast cancer

          -  Premenopausal women must have a negative serum or urine pregnancy test prior to
             starting on study treatment (post-menopausal is defined as > 6 months of amenorrhea
             prior hysterectomy)

        Exclusion

          -  More than or equal to 2 prior regimens for metastatic breast cancer

          -  Leptomeningeal disease

          -  Brain metastasis except for a solitary lesion that was resected or treated with gamma
             knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI was
             normal with no residual neurologic deficit

          -  History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence
             of interstitial lung disease on baseline chest computerized tomography (CT) scan

          -  History of irreversible neuropathy

          -  Another malignancy other than carcinoma in situ of the cervix or skin cancer

          -  Active uncontrolled bacterial viral or fungal infection

          -  Active pregnancy or breast feeding

          -  Patients with pre-existing neuropathy >= grade 2

          -  History of myocardial infarction, symptomatic congestive heart failure, unstable
             angina pectoris, or cardiac arrhythmia

          -  Patients with previous history of CTCAE grade >= 3 hypersensitivity to paclitaxel or
             Cremophor EL are not eligible