Randomized clinical trial to evaluate the predictive accuracy of a geneexpression profile-based test to select patients for preoperativetaxane/anthracycline chemotherapy for stage I-III breast cancer

• Conditions: Patients with histologically confirmed stage I-III invasive carcinoma of the breastfor whom adjuvant chemotherapy is indicated.

• Registration Number: EUCTR2005-000403-33-ES
• Lead Sponsor: GRUPO ESPAÑOL DE INVESTIGACIÓN EN CÁNCER DE MAMA (GEICAM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

Inclusion Criteria:
- Patients with histologically confirmed stage I-III invasive carcinoma of the breast
for whom adjuvant chemotherapy is indicated.
- Patients must have intact or measurable residual cancer (by mammogram, ultra
sonogram or physical exam) in the breast.
- Histological confirmation of invasive tumor needs to be performed on tissue
obtained by either core needle biopsy or by partial surgical excision of the tumor.
Routine estrogen, progesterone and HER-2 receptor determination must be
requested on the initial diagnostic specimen.
- Patients with a prior history of breast cancer are eligible.
- Patients with bilateral breast cancers are eligible if willing to undergo
pretreatment fine needle aspiration of both tumors.
- Women of childbearing potential must have a negative pregnancy test (serum or
urine beta HCG) prior to initiation of chemotherapy.
- Patients should have adequate organ function to tolerate chemotherapy, as
defined by:
peripheral granulocyte count of > 1,500/mm3,
platelet count > 100,000/mm3,
billirubin within normal values,
transaminase (SGPT) < 3.0 x upper limit of normal (ULN)
alkaline phosphatase (AlkP) < 4 x ULN
serum creatinine < 2.0 mg/dL
- Patients must sign an informed consent indicating that they are willing to
complete 18-24 weeks of chemotherapy before surgery and willing to undergo a
one-time pretreatment fine needle aspiration of the primary tumor in the breast.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have completed lumpectomy, segmental mastectomy or modified
radical mastectomy and, therefore no longer have any measurable cancer left in
their breast are not eligible.

Patients with stage IV, metastatic breast cancers are not eligible.
Patients for whom anthracycline or paclitaxel chemotherapies are
contraindicated, for example:
- hypersensitivity reactions to any of the medications
- uncompensated congestive heart failure
- myocardial infarction within the past 12 month
- pre-existing peripheral neuropathy > grade 2
- prior anthracycline therapy with > cumulative dose of 240 mg/m2

Patients who are pregnant or lactating are not eligible.

Women of childbearing potential who are not willing to use a contraceptive
method during the study are not eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified