Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first

Secondary Outcomes (3)

Recurrence-Free Survival (RFS)
Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers
Overall Survival (OS)
Time between the date of randomization and date of death
Distant Disease-Free Survival (DDFS)
Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first

Study Arms (3)

A

ACTIVE COMPARATOR

Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)

Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile

B

EXPERIMENTAL

Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile

C

EXPERIMENTAL

Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

Interventions

epidoxorubicine, ciclophosphamide, methotrexate, fluorouracileDrug

Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)

epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracileDrug

Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
epidoxorubicine, docetaxel, cyclophosphamide
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 70 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically proven breast cancer at the first diagnosis with \> or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 \[at least 1/10\], M0)
Ages ≥ 18 years and ≤ 70 years for patients who will be randomized to arm A and B. Ages ≥ 18 years and ≤ 65 years for patients who will be randomized to arm C

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis Administrative Office

Milan, Italy

MeSH Terms

Conditions

Breast Neoplasms

Interventions

MethotrexateDocetaxelCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-Ring

Study Officials

Georges Paizis, MD
Sanofi
STUDY DIRECTOR

Enrollment

998 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

December 1997

Date type not reported

This date has not been verified as actual or estimated.

Study of Docetaxel in Breast Cancer Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

A

B

C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

A

B

C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations