Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193115

Enrollment

Registered

2005-09-19

Start date

2004-03-31

Completion date

2009-01-31

Last updated

2010-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Detailed description

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.

Interventions

DRUGDocetaxel

DRUGDoxorubicin

DRUGCyclophosphamide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Treatment-related toxicities	—

Secondary

Measure	Time frame
Overall survival	—
Overall response rate	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026