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Breast

A MULTICENTER PHASE III RANDOMIZED TRIAL COMPARING DOCETAXEL IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE (TAC) VERSUS DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY DOCETAXEL (AC->T) AS ADJUVANT TREATMENT OF OPERABLE BREAST CANCER HER2NEU NEGATIVE PATIENTS WITH POSITIVE AXILLARY LYMPH NODES.

Unique Data Set IDBreast_SanofiU_2000_118
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients3298Comparator (Control) Arm Enrolled Patients1650RandomizationYesClinicalTrial.gov IDNCT00312208ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00312208?term=GMA+301&rank=3
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

A MULTICENTER PHASE III RANDOMIZED TRIAL COMPARING DOCETAXEL IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE (TAC) VERSUS DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY DOCETAXEL (AC->T) AS ADJUVANT TREATMENT OF OPERABLE BREAST CANCER HER2NEU NEGATIVE PATIENTS WITH POSITIVE AXILLARY LYMPH NODES.

Trial Summary and Conditions

Methodology: Prospective, non-blinded randomized phase III trial. Three thousand one hundred and thirty patients (3,130) were to be post-surgically stratified at inclusion according to center, number of axillary lymph nodes involved (1 to 3; 4 and more) and hormonal receptor status (estrogen and/or progesterone receptor status positive versus negative). They were randomly assigned to receive either: TAC x 6: Docetaxel 75 mg/m2 as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. (Sequence of administration: doxorubicin followed by cyclophosphamide followed by docetaxel.) OR as treatment AC x 4 to T x 4: Doxorubicin 60 mg/m2 as an IV bolus in combination with cyclophosphamide 600 mg/m2 as IV followed by docetaxel 100 mg/m2 as 1 hour IV infusion on day 1 every 3 weeks. Efficacy endpoints: Primary, Disease-Free Survival (time from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first. Secondary: Overall Survival (time from the date of randomization to the date of death of any cause). Safety: Adverse events reported by the patient or noted by the investigator; standard hematology and blood chemistry. Quality of life: Patient self-completion of 3 types of questionnaires (EORTC QLQ-C30 (version 3.0), EORTC QLQ-BR23 (version 1.0), EUROQOL EQ-5D. Pathologic and molecular marker: Investigation of the following markers: ER, PR, p53, MIB-1 and if indicated, investigation of MUC1, of the Bcl family (Bcl-2, bax, Bcl-X and Bag-1), and the tubulin isoforms (II, III, IV and Tau) were planned to be done.Socio-economic study: Patient self-completion of productivity and time loss questionnaire in 3 countries (Canada, Germany and USA), which was not analyzed.

Data Summary

Datasets contain the 1650 de-identified subjects assigned to the AC to T arm. Demographic, baseline information, safety, efficacy datasets, medication, dosing and quality of life datasets were included amongst others. Source data is raw data.

Study Objectives

Objectives: Primary objective: To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to doxorubicin and cyclophosphamide followed by docetaxel (AC->T) in operable adjuvant breast cancer HER2 negative patients with positive axillary lymph nodes. Secondary objectives: 1)To compare overall survival between the 2 above mentioned arms. 2) To compare toxicity and quality of life between the 2 above-mentioned arms. 3) To evaluate pathologic and molecular markers for predicting efficacy. 4) An independent socioeconomic study was planned in parallel with the clinical study but it was not analyzed

Outcome Measures

Primary Outcome Measures: Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) [ Time Frame: Median follow-up 65 months ] The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. Secondary Outcome Measures: Death From Any Cause (Overall Survival) [ Time Frame: Median follow-up of 65 months ] The considered event is death from any cause. The analysis is performed on the time from randomization to this event.

Available Downloads:

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

PROTOCOL: sanofi_xrp6976_tax_gma_301_study_protocol.pdf

CRF: sanofi_xrp6976_tax_gma_301_CRF.pdf

DATA DICTIONARY: sanofi_XRP6976_TAX_GMA_301_data_descriptors.xls

DATA (COMPARATOR ARM): XRP6976_TAX_GMA_Data.zip