Know Cancer

or
forgot password

A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer


Inclusion Criteria:



- 18 years of age or older adult women

- Instrumentation measurable lesions with histologically confirmed advanced (recurrent
or metastatic) breast cancer

- ECOG 0-2

- Advanced breast cancer in the past, patients who did not receive chemotherapy

- Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more
than 6 months until the patient

- life expectancy more than 3 months

- Agree in writing before the party to participate in a clinical trial to patients

Exclusion Criteria:

- immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients

- Severe infections requiring antibiotic therapy

- Clinically significant heart disease

- Pregnant or lactating woman

- Uncontrolled symptoms in the central nervous system (CNS) metastases

- Patients diagnosed with malignant tumors of other organs

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

response rate

Outcome Time Frame:

one year

Safety Issue:

Yes

Authority:

South Korea: Institutional Review Board

Study ID:

2011-GIRBA-2566

NCT ID:

NCT01784120

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • breast cancer
  • doxorubicin
  • genexol-PM
  • paclitaxel
  • Breast Neoplasms

Name

Location