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.

The Project Data Sphere Cancer Research Platform will be unavailable from 5 PM Eastern Time on Friday, 10/20 until 1 AM on Monday, 10/23 for necessary maintenance.

Breast

AN INTERGROUP PHASE III TRIAL TO EVALUATE THE ACTIVITY OF DOCETAXEL, GIVEN EITHER SEQUENTIALLY OR IN COMBINATION WITH DOXORUBICIN, FOLLOWED BY CMF, IN COMPARISON TO DOXORUBICIN ALONE OR IN COMBINATION WITH CYCLOPHOSPHAMIDE, FOLLOWED BY CMF, IN THE ADJUVANT TREATMENT OF NODE POSITIVE BREAST CANCER PATIENTS

Unique Data Set IDBreast_SanofiU_1998_127
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients2886Comparator (Control) Arm Enrolled Patients994RandomizationYesClinicalTrial.gov IDNCT00174655ClinicalTrial.gov URLhttps://clinicaltrials.gov/show/NCT00174655
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, Hormones, RadiationData Set TypeOther

Clinical Trial Title

AN INTERGROUP PHASE III TRIAL TO EVALUATE THE ACTIVITY OF DOCETAXEL, GIVEN EITHER SEQUENTIALLY OR IN COMBINATION WITH DOXORUBICIN, FOLLOWED BY CMF, IN COMPARISON TO DOXORUBICIN ALONE OR IN COMBINATION WITH CYCLOPHOSPHAMIDE, FOLLOWED BY CMF, IN THE ADJUVANT TREATMENT OF NODE POSITIVE BREAST CANCER PATIENTS

Trial Summary and Conditions

Patients will be post-surgically stratified at inclusion according to: participating center, number of axillary lymph nodes involved (1 to 3; 4 and more), age (< 50; >=50), and will be randomly assigned to receive either: Arm A1 4ADM->3CMF; Arm A2 4AC->3CMF;Arm B 3ADM-> 3TXT-> 3CMF; Arm C 4AT ->3CMF Where: ADM = doxorubicin (75), AC = doxorubicin + cyclophosphamide(60/600), TXT = docetaxel (100), AT = doxorubicin + docetaxel(50/75).The first cycle should be administered within 8 days following the randomization date. Dose-reduction and/or treatment delay and treatment discontinuation are planned for the 4 arms in case of severe hematological and/or non hematological toxicity. Hormonotherapy: (for Arms A1, A2, B and C) Tamoxifen 20 mg p.o. daily for 5 years, starting 4 to 5 weeks after day 1 of the last course of chemotherapy, in patients with ER and/or PgR positive tumors (i.e. >=1 per cent cells staining positively for ER and /or PgR with the immunohistochemistry technique, regardless of intensity. Radiotherapy: (for Arms A1, A2, B and C) Radiotherapy will be mandatory in case of breast-conservative surgery; allowed in case of mastectomy , according to the policy in use at each participating center. Each center will specify its own policy before study activation. Radiotherapy will begin 4 to 6 weeks after day 1 of the last course of CMF. Concomitant CMF and radiotherapy will be allowed although not recommended. Prophylactic regimens: Steroids:(only for Arms B and C during treatment with docetaxel). Antibiotics: (only for Arm C during treatment with AT).

Data Summary

Datasets contain the 994 de-identified subjects that did not receive Docetaxel. Demographic, baseline information, safety, efficacy datasets, medication, dosing and socioeconomic datasets were included amongst others. Source data is raw data.

Study Objectives

Primary objectives: 1) To compare disease-free survival of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes. 2)To compare disease-free survival of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: 1)To compare disease-free survival of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. 2)To compare disease-free survival of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes. (sequential mono-chemotherapy versus polychemotherapy) 3) To compare overall survival of treatment arms. 4)To compare toxicity of treatment arms. 5) To evaluate pathologic and molecular markers for predicting efficacy. 6) Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.

Outcome Measures

1) An intention to treat (ITT) analysis will be conducted for all randomized patients. In addition, an analysis will be conducted among the eligible patients. 2) Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. 3) Survival will be measured from the date of randomization up to the date of death of any cause.

Available Downloads:

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

PROTOCOL: sanofi_xrp6976d-RP56976_PR_315_protocol_Redacted.pdf

CRF: sanofi_xrp6976d-RP56976_PR_315-sample-crf.pdf

DATA DICTIONARY: XRP6976_RP56976_PR_315_data_definition.xls

DATA (COMPARATOR ARM): sanofi_XRP6976_RP56976_PR-315.zip