Clinical trial NCT02594371 (phase 3, status: active, not recruiting)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: oraxol, iv paclitaxel
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          1. Signed written informed consent

          2. Women ≥18 years of age

          3. Histologically- or cytologically-confirmed breast cancer for whom IV paclitaxel (as
             Taxol or generic) monotherapy has been recommended by their oncologist

          4. Measurable metastatic target lesion disease measurable by CT scan as per RECIST v1.1
             criteria

          5. Adequate hematological status as demonstrated by not requiring granulocyte-colony
             stimulating factor (G-CSF) or transfusion support to achieve the following at
             Screening:

               -  Absolute neutrophil count (ANC) ≥1.5 x 109/L

               -  Platelet count ≥100 x 109/L

               -  Hemoglobin ≥10 g/dL

          6. Adequate liver function as demonstrated by:

               -  Total bilirubin within normal limits (WNL)

               -  Alanine aminotransferase and aspartate aminotransferase ≤3 x upper limit of
                  normal (ULN)

               -  Alkaline phosphatase ≤3 x ULN or ≤5 x ULN if bone metastasis is present

               -  Gamma glutamyl transferase (GGT) ≤5 x ULN

          7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN

          8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          9. Life expectancy of at least 6 months, in the judgement of the investigator

         10. Subjects must be postmenopausal (≥12 months without menses) or surgically sterile (ie,
             by hysterectomy and/or bilateral oophorectomy) or must be using effective
             contraception and agree to used of contraception for 30 days after their last dose of
             assigned study treatment.

         11. Subjects who are of childbearing potential must have a negative screening serum
             pregnancy test.

        Exclusion Criteria:

          1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or
             previous investigational products

          2. If previously treated with a taxane (paclitaxel or docetaxel) as part of
             anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject
             relapsed less than 1 year following treatment

          3. Only evidence of metastatic disease is to bone or other nontarget or nonmeasurable
             lesions (including, for example, ascites or plural effusion) according to RECIST v1.1
             criteria

          4. Central nervous system metastasis, including leptomeningeal involvement

          5. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever
             is longer

          6. Are currently receiving other medications intended for the treatment of their
             malignancy

          7. Received radiation therapy within 2 weeks prior to signing informed consent and those
             for whom radiation therapy is planned within 6 months from the time of signing
             informed consent

          8. Women who are pregnant or breastfeeding

          9. Taking a medication known to be a strong P-gp inhibitor or inducer within 14 days of
             starting treatment

         10. Taking an oral medication with a narrow therapeutic index known to be a P-gp substrate
             within 24 hours prior to start of treatment

         11. Taking a medication known to be a strong cytochrome P450 (CYP) 3A4 inhibitor (eg,
             ketoconazole) or inducer (eg, rifampin or St. John's Wort) within 14 days of starting
             treatment

         12. Taking a medication known to be a strong inhibitor (eg, gemfibrozil) or inducer (eg,
             rifampin) of CYP2C8 within 14 days of starting treatment

         13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, myocardial infarction within the last
             6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease
             requiring oxygen, known bleeding disorders, or any concomitant illness or social
             situation that would limit compliance with study requirements

         14. Major surgery to the upper GI tract, or have a history of GI disease or other medical
             condition that, in the opinion of the Investigator may interfere with oral drug
             absorption

         15. History of significant hypersensitivity-type reactions to paclitaxel or Cremophor EL
             (polyoxyl 35 castor oil, NF) that would contraindicate the use of IV paclitaxel
             formulated with Cremophor EL

         16. Known allergic reaction or intolerance to contrast media

         17. Documented history of true systemic allergic reaction to 3 or more medications

         18. For whom the Investigator believes that participation in this study would not be
             acceptable

         19. Known chronic hepatitis or cirrhosis