Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country25 target enrollmentMarch 27, 2013

ConditionsUntreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 25
Locations: 1
Primary Endpoint: Response rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).

Registry

clinicaltrials.gov

Start Date

March 27, 2013

End Date

December 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent
•Female patients aged 18 years or older.
•Histologically or confirmed untreated invasive carcinoma of the breast
•Previous treated invasive breast carcinoma or ductal carcinoma in situ are allowed, assuming there is no evidence of disease at the moment of the inclusion in the protocol, and patients are not on any current treatment
•Candidates for breast conserving surgery: patients with a minimum size of 11 mm measured by breast US. Bilateral and multifocal tumors are allowed, assuming the biopsies pre- and post-treatment are performed in the same target lesion.
•HER2-positive (defined as either immunohistochemistry \[immuno-histochemistry \] 3+ or in situ hybridization \[ISH\] positive) as assessed by local laboratory on primary tumor (ISH positivity is defined as a ratio of 2.2 or greater for the number of HER2 gene copies to the number of signals for abnormality on chromosome 17 (CEP17), or for single probe tests, a HER2 gene count greater than 4) and/or by PCR.
•No evidence of metastatic disease
•Eastern Cooperative Oncology Group (ECOG) performance status 0/
•Left ventricular ejection fraction (LVEF) of at least 50%
•Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).

Exclusion Criteria

•Patients non-candidate for initial breast surgery or patient's candidate for neoadjuvant chemotherapy ;
•Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, anti-HER2 treatment other than trastuzumab, endocrine treatment, or radiotherapy ;
•Known hypersensibility to trastuzumab ;
•Serious uncontrolled concomitant disease that would contraindicate the use of trastuzumab or that would put the patient at high risk for treatment-related complications ;
•Inadequate organ function, evidenced by the following laboratory results:
•Absolute neutrophil count \<1,500 cells/mm3
•Platelet count \<100,000 cells/mm3
•Hemoglobin \<9 g/dL
•Total bilirubin greater than the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
•Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \>2.5 x ULN

Outcomes

Primary Outcomes

Response rate

Time Frame: assessed after 6 weeks

The response after 2 cycles of 3-weekly trastuzumab will be assessed as per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria and will be correlated with biomarkers.