Clinical trial · Interventional
Neoadjuvant GW572016 to Treat Breast Cancer
A Neoadjuvant Phase II Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients: Biologic Correlative Study
NCT00206427CI-TRIAL-00054152GWcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We want to learn whether GW572016 is effective in breast cancers that have HER2.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Intervention/Lapatinib (GW572016)
- interventionNames
- Drug: GW572016
- Drug: lapatinib
Primary outcomes (1)
- measure
- Clinical Response
- timeFrame
- at the end of week 6.
- description
- 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).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must be female. 2. Signed informed consent. 3. 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. 4. 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. 5. Negative serum pregnancy test (BHCG) within 7 days of starting study, if of child-bearing potential. 6. Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal. 7. Performance status (WHO scale) less than 2 and life expectancy greater than 6 months. 8. Age greater than 18 years. 9. No brain or leptomeningeal disease. 10. 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. Exclusion Criteria: 1. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential. 2. Severe underlying chronic illness or disease. 3. Cardiomyopathy or baseline LVEF \<50%. 4. Other investigational drugs while on study. 5. Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease. 6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded. 7. Taking any GW572016-prohibited medication (see GW572016 Prohibited Medications List in protocol) within 7 days of first dose of study medications.
References
Publications (0)
Data not yet available
No reference posted for this study.