Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01935492
Eligibility Criteria:
Inclusion Criteria:
* Female patients ≥ 18 years old.
* Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.
* Patients with measurable or evaluable-only (RECIST 1.1)
* Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.
* HER2/neu-negative disease
* Patients with an ECOG Performance Status ≤ 2.
* Life expectancy of \> 12 weeks.
* Signature of Informed Consent Form
Exclusion Criteria:
* Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
* Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.
* Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.
* Prior radiotherapy covering more than 30% of marrow-bearing bone.
* Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment.
* Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
* Chronic daily treatment with aspirin
* Chronic daily treatment with corticosteroids, with the exception of inhaled steroids.
* Current or recent treatment with another investigational drug or participation in another investigational study.
* Inadequate bone marrow, liver, renal function
* INR \> 1.5 or an aPTT \> 1.5 x ULN within 7 days prior to first study treatment.
* Known CNS disease, except for treated brain metastases.
* Patients with concurrent active malignancy
* Pregnant or lactating
* Women of childbearing potential not using effective, non-hormonal means of contraception
* Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment
* Core biopsy or other minor surgical procedure, within 7 days prior to day 1.
* Significant vascular disease within 6 months prior to day 1.
* Any previous venous thrombo-embolism \> CTC Grade 3.
* History of haemoptysis
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* Uncontrolled hypertension
* Clinically significant (i.e. active) cardiovasculair disease
* LVEF by MUGA or ECHO \< 50%.
* History of abdominal fistula, Grade 4 bowel obstruction or GI perforation, intra-abdominal abscess within 6 months of randomization.
* Serious non-healing wound, peptic ulcer or bone fracture.
* Known hypersensitivity to any of the study drugs or excipients.
* Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
* Psychiatric illness, physical examination or laboratory findings that may interfer with protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01935492
Study Brief:
Protocol Section:
NCT01935492