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Without drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection.

cfDNA was detected by dPCR

peng yuan, Prof

YiRan Si, Dr.

Dr. yuan, Prof

This was a prospective, single-center clinical study. The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and clinical response in patients with recurrent or metastatic breast cancer.

Patients were divided into two groups according to ctDNA HER2 amplification status by dPCR method. Group A consisted of patients with positive HER2 amplification at the time of enrollment. Plasma HER2 amplification status was measured by dPCR during dynamic monitoring. GroupB consists of patients with negative HER2 amplification when enrolled. Plasma samples were collected before treatment and breast cancer hotspot mutations were detected with NGS, According to the NGS test results, patient's specific mutations were analyzed and selected, which and plasma HER2 amplification status were measured by dPCR during dynamic monitoring.

The study was designed to investigate the relationship between plasma HER2 amplification or specific mutations abundance and imaging assessment in patients with recurrent or metastatic breast cancer. And also to investigate the proportion of predicting in advance the treatment efficacy of recurrent or metastatic breast cancer by plasma HER2 ctDNA, as well as the median time difference between predicted clinical efficacy by changes in abundance of plasma HER2 amplification specific mutations and medical imaging evaluation in patients.

The study only focus on ctDNA detection and does not involve any interventions.

Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

Detection of HER2 Amplification Status and Dynamic Monitoring of Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

Questgenomics

Chinese Academy of Medical Sciences

Principal Investigator

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.

Daehwa Pharmaceutical Co., Ltd.

Intravenous administration of Reference1613

Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)

SPARC1613

Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)

Reference1613

SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.

The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes

Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR	NCT03947736	Recurrent or Me...	cfDNA was detec...	18 Years - 75 Years	ChineseAMS
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy	NCT03315364	Recurrent or Me...	Oral paclitaxel Paclitaxel inje...	19 Years -	Daehwa Pharmaceutical Co., Ltd.
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer	NCT03109249	Recurrent or Me...	SPARC1613 Reference1613	18 Years -	Sun Pharma Advanced Research Company Limited
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer	NCT03109249	Recurrent or Me...	SPARC1613 Reference1613	18 Years -	Sun Pharma Advanced Research Company Limited
Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR	NCT03947736	Recurrent or Me...	cfDNA was detec...	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for recurrent or metastatic breast cancer