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Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility


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

Thank you

Trial Information

Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility


Inclusion Criteria:



- adenocarcinoma breast cancer

- ECOG performance status of 0 or 1

- peripheral neuropathy less than or equal to 1

- discontinued hormonal therapy as a chemoprevention while onstudy

- LVEF by MUGA > 55%?

- Absolute neutrophil count (ANC)> 1000/µL)

- platelet count > 100,000/µL)

- SGOT OR SGPT < 92.5 units/L

Exclusion Criteria:

- Stage IV breast cancer

- any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT
breast cancer

- pregnant or lactating patients

- active second malignancy, other than adequately treated non-melanoma skin cancers or
in situ cervical cancer

- previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or
other drugs formulated in Cremophor EL?

- unstable angina, congestive heart failure, current use of digitalis, beta-blockers,
or calcium blockers for therapy of congestive heart failure, arrhythmia requiring
medical therapy, or a history of a myocardial infarction within 12 months

- psychiatric illness that prevents her from understanding the nature of this study and
complying with protocol requirements?

- active, unresolved infections

- sensitivity to E. coli derived proteins

- prior chemotherapy with an anthracycline

- prior Herceptin therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

cardiac saftey

Outcome Description:

LEVF by Muga scan

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Chau Dang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

04-126

NCT ID:

NCT00591851

Start Date:

December 2004

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • breast cancer
  • adenocarcinoma of the breast
  • cardiac safety
  • Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021