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:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00349934
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage IV breast adenocarcinoma, histologically proven by biopsy of the primary tumor and/or a metastasis.
* Female not pregnant (or with negative pregnancy test) or male.
* Fertile patients must use effective contraception during and for 3 months after drug administration.
* 18 years or above.
* ECOG performance status 0-1.
* Expected survival longer than three months.
* Resolution of toxicity of prior therapy to grade \< 2 (except alopecia).
* With or without prior adjuvant or neoadjuvant chemotherapy (authorized).
* With or without hormone therapy in adjuvant and/or the advanced setting (authorized).
* Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
* Biphosphonate therapy must have started at least 4 weeks prior to first dosing of the study drug.
* Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required.
* Total white cell count ≥ 3.109/L.
* Platelet count ≥ 100.109/L.
* Hemoglobin \> 9 g/dL or \> 5.58 mmol/L.
* Serum creatinine \< 160 µmol/L.
* Total bilirubin \< 20 mmol/L, except for familial cholemia (Gilbert's disease).
* Serum ASAT and ALAT \< 3 times the upper limit of normal or \< 5 times upper limit of normal if liver metastases are present.
* Able to give written informed consent and to comply with the protocol.
Exclusion Criteria:
* Prior chemotherapy for metastatic breast adenocarcinoma.
* Disease-free interval \< 12 months from last dose of adjuvant chemotherapy.
* Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
* Inflammatory carcinoma.
* Systemic chemotherapy, hormone or endocrine therapy given as breast cancer therapy within 30 days prior to first dosing of the study drug.
* Any investigational drug within 30 days prior to first dosing of the study drug.
* Candidate for treatment with trastuzumab or administration of trastuzumab within 30 days prior to first dosing of the study drug.
* Known cerebral or leptomeningeal metastases.
* Pregnancy or breast feeding.
* Serious intercurrent infection within the 30 days prior to first dosing of the study drug.
* Motor or sensory peripheral neuropathy ≥ 2 according to the National Cancer Institute criteria.
* Congestive heart failure.
* Active acute or chronic infection.
* Active autoimmune disease requiring immunosuppressive therapy.
* Known HIV positivity.
* Life threatening illness unrelated to cancer.
* Previous malignancies within the last two years other than breast carcinoma, successfully treated squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated with cone biopsy.
* Previous history of major psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide informed consent or to comply with the protocol.
* Corticosteroids unless used as substitutive therapy or before each injection of paclitaxel.
* Past history of severe allergic episodes and/or Quincke edema.
* Past or present history of any organic disorder likely to modify absorption, distribution or elimination of the study drug.
* Alcohol or substance abuse disorder.
* Radiotherapy within the 30 days prior to first dosing of the study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00349934
Study Brief:
Protocol Section:
NCT00349934