Study of the Efficacy and Safety of Letrozole Combined Wi... | NCT00171847

Studies
Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

NCT00171847

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Mar 31, 2010Estimated

Enrollment

93Actual

Phase

Phase 4

Conditions

Metastatic Breast Cancer

Interventions

Letrozole
Trastuzumab plus Letrozole
Letrozole

Countries

Germany

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

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Oct 2008Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

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 30, 2010

Last Update Posted Date

Mar 31, 2010Estimated

Name	Class
Roche - Prof. Dr. Jens Huober et al.	UNKNOWN

Description Module

Brief Summary

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A - HER-2 +ve patients with Femara alone	Experimental	Drug: Letrozole
B - HER-2 +ve patients with Femara + Herceptin	Experimental	Drug: Trastuzumab plus Letrozole
C - HER-2 -ve patients with Femara alone	Experimental	Drug: Letrozole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Letrozole	Drug		A - HER-2 +ve patients with Femara alone
Trastuzumab plus Letrozole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months		3 months

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate/Clinical Benefit rate		3 months
Time to treatment failure		3 months
Duration of response/clinical benefit during treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal
Her-2 overexpression and ER and/or PgR positive
Metastatic Breast Cancer

Exclusion Criteria:

Previous treatment with trastuzumab
Significant Liver or renal impairment
Erbb2 negative and/or ER and PgR negative

Other protocol-defined inclusion / exclusion criteria may apply.

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
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Tübingen			Germany

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077289	Letrozole
D000068878	Trastuzumab

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided