Standard Neoadjuvant Chemotherapy Versus Genomic Driven C... | NCT01180335

Studies
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer

NCT01180335

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

303Actual

Phase

Phase 3

Conditions

Breast Cancer

Interventions

Chemotherapy
Genomic driven chemotherapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Aug 10, 2010

First Posted Date

Aug 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Name	Class
Institut Curie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

Detailed Description

After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy	Active Comparator	4 cycles FEC followed by 4 cycles docetaxel	Drug: Chemotherapy
Genomic driven chemotherapy	Experimental	High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.	Drug: Genomic driven chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy	Drug	4 cycles FEC followed by 4 cycles docetaxel	Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete response rate based on the histology		Tumoral assessment at 4 and 8 cycles

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Invasive breast cancer not eligible for conservative surgery
Her2 negative
Amount of tumor cells >30% on HES slides
RIN>6 and amount of RNA>1 ug
No metastases
Subject, age > 18 years and <65 years old
Signed written informed consent
PS 0-1
No previous treatment for breast cancer
Adequate organ function
FEVG >50%

Exclusion Criteria:

In situ carcinoma
Multifocal cancers
Her2+
Presence of metastasis
Genomic testing not feasible because of tumor cells <30%, RIN<6, insufficient amount of RNA
Organ dysfunction that contraindicates chemotherapy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florence LEREBOURS, MD	Centre René Huguenin	Principal Investigator
Jean-Yves PIERGA, MD	Institut Curie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94800	France

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided