Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Breast

A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of operable breast cancer patients with positive axillary lymph nodes

Unique Data Set IDBreast_SanofiU_1997_120
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients1491Comparator (Control) Arm Enrolled Patients746RandomizationYesClinicalTrial.gov IDNCT00688740ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/results?term=NCT00688740&Search=Search
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of operable breast cancer patients with positive axillary lymph nodes

Trial Summary and Conditions

Prospective, non-blinded randomized phase Ill trial. Patients will be post-surgically stratified at inclusion first according to the participating institution then according to number of axillary lymph nodes involved (1 to 3; 4 and more) and will be randomly assigned to receive either: TAC: Docetaxel 75 mg/m2 as 1 hour i.v. infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as i.v. bolus on day 1 every 3 weeks. OR FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks. Dose reduction and/or treatment delay and treatment discontinuation are planned for the 2 arms in case of severe hematological and/or non-hematological toxicities. For Both Arms: Tamoxifen 20 mg p.o. daily for 5 years, starting 3 to 4 weeks after the last course of chemotherapy for patients with positive estrogen and/or progesterone receptors unless there is a contraindication for the use of tamoxifen therapy. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy and resolution of any side effect. Postmastectomy radiation therapy, and ipsilateral nodal radiation therapy, may be used at the discretion of the treating radiation oncologist. This will be done according to the guidelines at each institution. All included patients in both arms will receive a fixed number of 6 cycles of treatment.

Data Summary

Datasets contain the 746 de-identified subjects assigned to the Fluoruoracile/Doxorubicin/Cyclophosphamide arm. Demographic, Baseline information, safety, efficacy datasets, medication, dosing and quality of life are amongst datasets that are included.

Study Objectives

Primary Objective: To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) in operable breast cancer patients with positive axillary lymph nodes. Secondary Objectives: To compare overall survival between the 2 above mentioned arms. To compare toxicity and quality of life between the 2 above mentioned arms. To evaluate pathologic and molecular markers for predicting efficacy. An independent socio-economic study will be conducted in parallel with the clinical study.

Outcome Measures

Primary Outcome Measures: Number of Participants With Disease-Free Survival Events Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. Secondary Outcome Measures: Overall Survival - time from the date of randomization up to the date of death of any cause. Number of Participants With Second Primary Malignancies (Toxicity): Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_XRP6976D_TAX316 Amended_Protocol 6_Redacted.pdf

CRF: sanofi_XRP6976_TAX316_crf_Redacted.pdf

DATA DICTIONARY: sanofi_XRP6976_TAX316_data_definition.doc

DATA (COMPARATOR ARM): sanofi_XRP6976_TAX316.zip