Know Cancer

or
forgot password

An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer


Inclusion Criteria:



- Breast cancer diagnosis node-positive or high risk node negative

- Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.

Exclusion Criteria:

- Metastatic breast cancer

- Clinically significant cardiac disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20040137

NCT ID:

NCT00261313

Start Date:

December 2005

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Doses dense chemotherapy
  • Growth factor support
  • Adjuvant Breast Cancer
  • Breast Neoplasms

Name

Location