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Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer


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

Thank you

Trial Information

Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer


Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin +
Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation
therapy after completion of chemotherapy. Patients with positive estrogen and/or
progesterone receptors will begin anti-estrogen therapy after the last course of
chemotherapy.


Inclusion Criteria:



To be included in this study, you must meet the following criteria:

- Histologically proven breast cancer

- Females, age greater than 18 years

- Ability to perform activites of daily living with minimal assistance

- Normal cardiac function

- Adequate bone marrow, liver and kidney

- Signed informed consent prior to beginning specific protocol procedures

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Prior systemic anticancer therapy for breast cancer

- Prior anthracycline or taxane based chemotherapy for any malignancy

- Pregnant or breast-feeding women.

- Pre-existing moderate to severe motor or sensory neurotoxicity

- Other serious illness or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

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:

Treatment-related toxicities

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 69

NCT ID:

NCT00193115

Start Date:

March 2004

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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