Neoadjuvant Herceptin in Patients With Breast Cancer | NCT00133796

Studies
Neoadjuvant Herceptin in Patients With Breast Cancer

NCT00133796

Sponsor

Mothaffar Rimawi

Status

Terminated

Last Update Posted

Feb 7, 2017Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

BREAST CANCER

Interventions

Herceptin

Countries

United States

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closed to accrual 4/19/2006 / Study doesn't qualify for reporting.

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Sep 2005Actual

Completion Date

Apr 2007Actual

First Submitted Date

Aug 22, 2005

First Submission Date that Met QC Criteria

Aug 23, 2005

First Posted Date

Aug 24, 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

Feb 3, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Name	Class
Genentech, Inc.	INDUSTRY

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

The purposes of this study are to better understand how Herceptin causes tumors to become smaller and to find out how effective Herceptin, together with chemotherapy, is in treating advanced breast cancer.

Detailed Description

We want to determine the effects of Herceptin and to determine its efficacy in women with HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of an array of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin.

The other aim of this study would be to determine clinical response to therapy with Herceptin and Taxotere.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
Heceptin	Experimental	Herceptin administered to enrolled subjects	Drug: Herceptin

Name	Type	Description	Arm Group Labels	Other Names
Herceptin	Drug	IV	Heceptin	Trastuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer	A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin	1 year

Secondary Outcomes

Measure	Description	Time Frame
To determine clinical response to therapy with Herceptin and Taxotere		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients must be female.
Informed consent must be signed.
Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive.
Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
Performance status (World Health Organization [WHO] scale) < 2 and life expectancy > 6 months.
Age > 18.
No metastatic disease without concomitant primary breast cancer.
No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
Severe underlying chronic illness or disease.
Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) < 50%.
Patients on other investigational drugs while on study.
Severe or uncontrolled hypertension defined as blood pressure (BP) > 180/100 on three separate occasions.
History of congestive heart failure.
History of coronary arterial disease.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins