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Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.


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

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Trial Information

Phase II Study of Dimethyldiguanide Combined With AI Compared to AI in Postmenopausal HR(+) Metastatic Breast Cancer.


The addition of dimethyldiguanide might increase the efficacy of AI in patients with
metastatic breast cancer after the failure of the first line endocrine therapy.


Inclusion Criteria:



- postmenopausal HR positive breast cancer patients;

- inoperable locally advanced or metastatic breast cancer patients;

- candidate for endocrine therapy;

- ECOG equal to or less than 1;

- adequate bone marrow function(Hb>=90g/L, WBC >=3.5×10^9/L,ANC>=1.5×10^9/L,
PLT>=80×10^9/L; adequate renal function(Ccr<=ULN);adequate liver
function(ALT,AST,AKP<=2.5*ULN,or <=5*ULN if liver metastases)

- life expectancy >=12weeks;

- no severe history disease of liver,heart,lung or kidney;

- written informed consent form;

Exclusion Criteria:

- Her-2 overexpression;

- patients who has visceral endocrisis;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Xichun Hu, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

Fudan BR2012-12

NCT ID:

NCT01654185

Start Date:

July 2012

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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