Neoadjuvant GW572016 to Treat Breast Cancer

NCT00206427 | Completed Phase 2 Results DMC

• 2 other identifiers: H 15430Neoadjuvant GW572016
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

We want to learn whether GW572016 is effective in breast cancers that have HER2.

Conditions

Breast Cancer

Keywords

Advanced; Breast; Cancer; Neoadjuvant; HER2

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).

  at the end of week 6.

Secondary Outcomes (2)

• Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2

  Baseline and 6 weeks

• Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3

  Baseline and 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention/Lapatinib (GW572016)

Drug: GW572016; Drug: lapatinib

Interventions

GW572016 DRUG

Lapatinib, 500 mg

Also known as: TyKerb, Lapatinib

Intervention

lapatinib DRUG

Lapatinib 500 mg PO

Also known as: TyKerb, GW572016

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be female.
• Signed informed consent.
• 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 \>/- 5 cm, and/or are deemed surgically inoperable, with Stage IIIb, IIIc, or IV disease.
• HER2 overexpressing tumors defined as HercepTest score of 3+, or \>/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of \>/- 5 (in Dr. Allred's laboratory) or gene amplified.
• 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 the institution's upper limit of normal.
• Performance status (WHO scale) less than 2 and life expectancy greater than 6 months.
• Age greater than 18 years.
• No brain or leptomeningeal disease.
• No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated core-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

You may not qualify if:

• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• Severe underlying chronic illness or disease.
• Cardiomyopathy or baseline LVEF \<50%.
• Other investigational drugs while on study.
• Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded.
• Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• GlaxoSmithKline: collaborator

Study Sites (3)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Web site

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mothaffar Rimawi
• Organization: Baylor Breast Cancer

rimawi@bcm.tmc.edu

713-798-1311

Study Officials

• Mothaffar Rimawi, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: September 29, 2021
• Results First Posted: March 7, 2012

Record last verified: 2021-09

Locations

US (3)