Oral Paclitaxel Efficacy Safety and PK in Recurrent and metAstatic Breast Cancer

Inclusion Criteria:

1. Subjects who are ≥18 years of age on the date of written informed consent.

2. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on
histopathology examination

3. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in
situ hybridization (ISH) assessment of tumor samples

4. Subjects who have received up to 3 lines of therapy for advanced disease, without
prior exposure to taxane in the advanced stage setting

5. Subjects who have a life expectancy of ≥12 weeks.

6. Subjects who are able to take oral medication.

7. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group
(ECOG) scale.

8. Subjects who have measurable disease according to the Response Evaluation Criteria in
Solid Tumors Version 1.1 (RECIST version 1.1).

9. Subjects who have adequate organ functions

10. Subjects who are willing and able to comply with scheduled visits, treatment plans,
laboratory tests, and procedures.

11. Subjects who have voluntarily agreed to participate by giving written informed
consent.

12. Women of childbearing potential who have negative pregnancy test results

Exclusion Criteria:

1. Subjects who have history of severe hypersensitive reaction to the active ingredient
or any excipients of DHP107 or IV paclitaxel.

2. Subjects who have received prior taxane therapy in the metastatic setting

3. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was
completed within 6 months prior to entry into the study.

4. Subjects who received radiation therapy within 2 weeks of randomization (C1D1)

5. Subjects who were diagnosed with New York Heart Association (NYHA) Class II congestive
heart failure or have clinically significant arrhythmia not controlled by medication
prior to study entry.

6. Subjects who developed cardiovascular disease within 24 weeks prior to study entry,
which is deemed to be clinically significant by the Investigator.

7. Subjects with known active hepatitis B or C infection, or hepatobiliary disease, or
known history of immunodeficiency virus infection.

8. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry

9. Subjects with uncontrolled medical or mental illness that, in the Investigator's
judgement, could affect treatment tolerability or compliance.

10. Subjects diagnosed with other malignant primary tumor

11. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at
the time of screening.

12. Subjects who are currently receiving prescription or non prescription medications or
other products known to be moderate or potent inhibitors/inducers of CYP3A4, P-gp, or
CYP2C8.

13. Subjects who cannot tolerate oral administration as determined by the Investigator

14. Pregnant or breastfeeding women.

15. Subjects who have received any investigational drugs or devices within 4 weeks before
the first day of study treatment (C1D1).