Phase 2
N=49
Neoadjuvant GW572016 to Treat Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00206427 ↗Enrolled (actual)
49
Serious AEs
6.1%
Results posted
Mar 2012
Primary outcome: Primary: Clinical Response — 3; 30; 11; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GW572016 (Drug); lapatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baylor Breast Care Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response |
3; 30; 11; 3 | — |
| SECONDARY Inhibition of HER1 and HER2 Signaling as Determined by EGFR, HER2, and pHER2 |
0; 0; 3; 3; 1.5; 1.5 | — |
| SECONDARY Inhibition of HER1 and HER2 Signaling as Determined by ki67 and CC3 |
71; 49; 1.80; 1.84 | — |
Summary
We want to learn whether GW572016 is effective in breast cancers that have HER2.
Eligibility Criteria
Inclusion Criteria
- 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.
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 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.
Data sourced from ClinicalTrials.gov (NCT00206427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.