Know Cancer

or
forgot password

An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer


Phase 2
20 Years
70 Years
Open (Enrolling)
Female
Recurrent Breast Cancer, Metastatic Breast Cancer

Thank you

Trial Information

An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer


Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes,
platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment
efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter
phase II study was designed to evaluate the response rate, toxicity, progression free
survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast
cancer.


Inclusion Criteria:



1. Women aged : 20~70 years

2. WHO (ECOG) performance status 0-2

3. Patients with measurable lesion assessed by imaging using the RECIST (Response
Evaluation Criteria In Solid Tumor) guideline

4. patients had previously not received chemotherapy of recurrent or metastatic lesion.

5. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

1. Patients with previous chemotherapy for recurrent breast cancer

2. Breast cancer recurrence within 12 months after taxane treatment

3. Her-2/neu expression breast cancer

4. Patients with malignancies (other than breast cancer) within the last 5 years, except
for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell
carcinoma of the skin.

5. Brain metastasis

6. uncontrolled infection, medically uncontrollable heart disease

7. other serious medical illness or prior malignancies

8. Pregnant or lactating women were excluded.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Sehwan Han, MD.PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG008

NCT ID:

NCT01351597

Start Date:

April 2011

Completion Date:

September 2013

Related Keywords:

  • Recurrent Breast Cancer
  • Metastatic Breast Cancer
  • recurrent breast cancer
  • metastatic breast cancer
  • docetaxel
  • oxaliplatin
  • Breast Neoplasms

Name

Location