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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Doxorubicin

Drug: Cyclophosphamide

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193115

11251 (Registry Identifier)

SCRI BRE 69

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No 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/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.