Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without atezolizumaB as first-line treatment in advanced triple negative Breast cancer - Triple-B study

BOOG Study Center0 sites304 target enrollmentApril 18, 2013

ConditionsMetastatic breast cancer MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsEndoxan Avastin Carboplatine Sandoz Taxol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic breast cancer
Sponsor: BOOG Study Center
Enrollment: 304
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 18, 2013

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BOOG Study Center

Eligibility Criteria

Inclusion Criteria

•\-Metastasized or locally advanced incurable triple negative breast cancer; patients with stage IV at diagnosis are eligible as well. If the primary lesion is the only measurable lesion according to RECIST criteria, every locoregional treatment must be mentioned to the investigators.
•\-Histologically confirmed triple negative breast cancer (ER: \< 10% nuclear staining of tumor cells on IHC; HER2: either score 0 or 1 at immunohistochemistry or negative at in situ hybridization \[CISH or FISH] in case of score 2 or 3 on IHC) 47
•\-Histological confirmation of triple negative breast cancer of a metastatic lesion is
•recommended
•\-Histological or cytological confirmation of metastatic breast cancer is required in case of
•normal CA 15\.3 levels, unless according to the principal investigators there is no doubt that the metastatic disease concerns triple negative breast cancer origin based on the course of the disease. In case patient has bone\-only disease, a bone\-biopsy of a metastatic lesion should be taken. A patient is only eligible if there is measurable or evaluable disease according to RECIST v1\.1 (bone metastases with soft tissue masses measuring \= 10mm).
•\-Primary tumor or metastasis tissue (tumor blocks, or 10 x10 µm blank slides FFPE tumor material) sent to NKI\-AVL for BRCA\-like testing
•\-Pretreatment histological biopsy of a metastatic lesion for the translational research questions (tumor tissue from bone metastases cannot be used). In case patient has metastatic lesions that are too risky to take a biopsy from according to the principal investigators or radiologist (including but not limited to mediastinal lymph nodus with EBUS) or the biopsy failed, patient could be included without a pretreatment biopsy of a metastatic lesion.
•\-No previous cytotoxic therapy for metastatic disease
•\-Disease\-free interval of at least 12 months after completion of (neo)adjuvant paclitaxel or (neo)adjuvant platinum compound

Exclusion Criteria

•\-Receptor conversion to hormone receptor positive(\= 10% ER positive tumor cells 44 or HER2 positive
•\-Diagnosis of any other active malignancy prior to randomization, except those that are not believed to influence the patient’s prognosis and do not require further treatment. This includes, but is not limited to adequately treated basal cell or squamous cell skin cancer and carcinoma in situ of the cervix
•\-Other antitumor therapy within the previous 21 days,with the exception of recently started(within 21 days of randomization)endocrine therapy
•\-Radiotherapy with palliative intent within the previous 7 days before start of study treatment. After 7 days patients may be included under the condition that at least one measurable/evaluable lesion was not irradiated.If radiation is needed on bone with an extensive amount of bone marrow, the interval between treatment and randomization might be longer(at the physician’s discretion)
•\-Known CNS disease except for treated brain metastases.Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging during the screening period and no ongoing requirement for systemic corticosteroids.Anticonvulsants(stable dose)are allowed.Treatment for brain metastases may include whole brain radiotherapy, radiosurgery(gamma knife, LINAC or equivalent)or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 2 weeks prior to randomization will be excluded
•\-Use of denosumab;Patients who are receiving denosumab must discontinue denosumab use and replace it with a bisphosphonate instead while on study.There is no required minimum washout period for denosumab
•\-Uncontrolled serious medical or psychiatric illness
•\-Pre\-existing peripheral neuropathy\>grade 1(NCI\-CTC AE(version 4\.03\))at inclusion
•\-Severe infection within 4 weeks prior to randomization
•\-Received antibiotics within 2 weeks prior to cycle 1,day 1,for a severe infection(in need of hospitalization or in need of i.v. antibiotics)