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Clinical Trials/NL-OMON52986
NL-OMON52986
Recruiting
Phase 2

Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without Bevacizumab as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study);Title after protocol amendment August 12, 2017: 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) - TRIPLE-B study

BOOG Study Center0 sites304 target enrollmentTBD
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Conditionsbreast cancertriple negative breast cancer10006291

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
breast cancer
Sponsor
BOOG Study Center
Enrollment
304
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
BOOG Study Center

Eligibility Criteria

Inclusion Criteria

  • •\- Histologically confirmed triple negative metastasized or locally advanced
  • •incurable breast cancer. See protocol section 5\.2 for more details.
  • •\- Histological confirmation of triple negative breast cancer of a metastatic
  • •recommended
  • •\- Histological or cytological confirmation of metastatic breast cancer is
  • •required in case of
  • •normal CA 15\.3 levels. Exception: see protocol section 5\.2 for details.
  • •\- Primary tumor or metastasis tissue sent to NKI\-AVL for BRCA\-like testing
  • •\- Pretreatment histological biopsy of a metastatic lesion for the
  • •translational research

Exclusion Criteria

  • •\- Receptor conversion to hormone receptor positive (defined as \>\= 10% ER
  • •positive tumor cells) or HER2 positive
  • •\- 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
  • •study medication (see protocol 5\.3 for details)
  • •\- Known CNS disease except for treated brain metastases (see protocol 5\.3 for
  • •\- Pre\-existing peripheral neuropathy \> grade 1 (NCI\-CTC AE (version 4\.03\) at
  • •\- Use of denosumab is not allowed. See protocol section 5\.3 for details.
  • •\- Severe infection in the last 4 weeks.

Outcomes

Primary Outcomes

Not specified

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