PREDICTION OF RESPONSE AND TOXICITY IN PATIENTS WHO RECEIVE PACLITAXEL AND AVASTIN FOR BREAST CANCER. A CORRELATIVE, MULTICENTRIC, GENOMIC, PROTEOMIC AND PHARMACOGENIC STUDY

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-009-08
• Lead Sponsor: HOSSIER ONCOLOGY GROUP,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Written informed consent and HIPAA authorization to release personal health information.
• Planned chemotherapy regimen with placitaxel and Avastin for the treatment of metastatic breast cancer of the patient.
• ECOG functional status scale from O to 1.
• Histological and cytologic confirmation of breast adenocarcinoma with measurable, locally recurrent, locally advanced disease (which is not receptive to resection with curative intent), or metastatic.
• Total neutrophil count> 1200 / mm3
• Platelet count> 100,000 / mm3
• Total bilirubin <1.5 mg / dL
• SGOT (AST) <2x of normal upper limit (<5x of normal upper limit in patients with known liver involvement)
• PTT <1.5x of normal upper limit
• INR <1.5x of normal upper limit
• Women of 18 years.
• Patients must agree to have a biopsy performed to obtain fresh tissue or can identify a block of FFPE tissue in which tissue samples can be obtained to complete the test for this study.

Exclusion Criteria

• Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer.
• Hormone therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks before entry into the study.
• Patients should not have had adjuvant or neoadjuvant taxane therapy within 12 months before entry into the study.
• Patients with breast cancer HER-2 overexpression (gene amplification by FISH or overexpression 3+ by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin.
• Patients should not have had a major surgical procedure within 4 weeks prior to entering the study, (placement of vascular access device, breast biopsy, will not be considered major surgery.)
• Patients should not have had a minor surgical procedure, access device placement, or fine needle aspiration within 7 days of initiating protocol therapy.
• Patients must not have received radiation within 2 weeks before entering the study, xx O´IW.
• The previously irradiated area (s) should not be the only place of illness for study entry.
• Patients should not have a history of bleeding diathesis or have had anticoagulant therapy within 10 days prior to study entry, (low-dose anticoagulant therapy is allowed to maintain evidence of a vascular access device.)
• Patients with a prior history of deep vein thrombosis or pulmonary embolism are not eligible.
• Use of aspirin (> 325 mg / day) or another nonsteroidal anti-inflammatory drug known to inhibit platelet function daily is not allowed within 10 days of study entry.
• Patients who are using any of the medications known to inhibit platelet function are not eligible; dipiridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pietal).
• Clinically significant cardiovascular or cerebrovascular disease including previous myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II or greater peripheral vascular disease, Grade II congestive heart failure or greater according to the Heart Association of New York City (NYHA), hypertensive crisis, hypertensive encephalopathy or uncontrolled hypertension (PS> 150, PD> 100).
• Patients should not have a history of TIA (Transient Ischemic Attack) or CVA (Vascular Brain Injury) within 6 months prior to the study.
• Patients should not have a history of radiological evidence of CNS metastasis including brain lesions previously treated, extracted or asymptomatic or leptomeningeal compromise (a CT or MRI should be obtained within 6 months prior to study entry)
• Patients should not have a wound or fracture that does not heal.
• Patients should not have hypersensitivity to placitaxel or to medications that use Cremophor as a vehicle, Chinese hamster ovarian cell products or other recombinant human antibodies.
• Women should not be pregnant or breastfeeding.
• Women of childbearing age should use an accepted and effective method of contraception (hormonal or barrier method of birth control, abstinence) while on treatment and for a period of 3 months thereafter.
• Women of childbearing age should use a negative pregnancy test within 7 days prior to their registration for protocol therapy. Patients are not considered to have fertile potential if they have been surgically sterilized (they have had a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are menopausal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified