Neoplasms

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Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

* 28 days (4 weeks) will be set as one cycle of administration and Liporaxel® will be administered for 3 weeks, twice a day, every morning and evening (D1, D8, D15) and will take a week off on 4th week.
* Liproaxel® 200mg/m2 will be orally administered twice a day (morning, evening) 1 hour after meal for D1, D8, D15 of every cycle. 10 hour-interval is recommended for between each administration.

* 28 days (4 weeks) will be set as one cycle and for every 3 week administration, 1 week off dose period will be given.
* Taxol® 80mg/m2 will be administered via IV and it must be diluted before drip administration. Dilute with 0.9% sodium chloride injection solution to make final concentration of 0.3-1.2 mg/mL.

Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Oral paclitaxel

Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Paclitaxel injection

Sung-bae Kim, M.D., Ph.D

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

1. Phase II clinical trial

   * Multicenter, Open-label, Single arm, Simon's optimal two-stage design
2. Phase III clinical trial

   * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization to End of treatment(EOT).

To evaluate changes versus baseline using the EQ-5D.

Spots Global Cancer Trial Database for firstline chemotherapy