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Clinical Trials/EUCTR2017-000220-10-BE
EUCTR2017-000220-10-BE
Active, not recruiting
Phase 1

A randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone receptor positive breast cancer - ICON CA209-9F

Oslo University Hospital0 sites75 target enrollmentMarch 27, 2019
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DrugsYervoy (ipilimumab)Opdivo (nivolumab)Caelyx (Pegylated liposomal doxorubicin)Sendoxande (cyclophosphamide)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Oslo University Hospital
Enrollment
75
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 27, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\.Metastatic hormone receptor positive breast cancer (primary or recurrent), defined as ER\+ \>1% in metastatic biopsy (archival material or study biopsy) or cytology and HER2 negative in the last biopsy or cytology evaluable for HER2\. HER2\-analysis is to be perfomed according to national criteria.
  • •2\.Adequate core or excisional study biopsy of a tumor lesion. Lesions in previously irradiated areas may only be used for the biopsy if the lesion has appeared or progressed after radiation. . No anti\-tumor treatment is allowed between the time point for biopsy and study entry.
  • •3\.Measurable metastatic disease according to RECIST
  • •4\.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •5\.Signed Informed Consent Form
  • •6\.Women or men aged \= 18 years
  • •7\.A minimum of 12 months from adjuvant/neoadjuvant chemotherapy with antracyclins to relapse of disease.
  • •8\.A maximum of one previous line with chemotherapy in the metastatic setting
  • •9\.Chemotherapy is considered as preferred treatment
  • •10\.Previous endocrine and targeted therapy is allowed

Exclusion Criteria

  • •1\.Malignancies other than breast cancer within 5 years prior to randomization
  • •2\.Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \> 2 weeks prior to randomization
  • •3\.Known CNS disease, except for asymptomatic CNS metastases, provided all of the following criteria in the protocol are met.
  • •4\.Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters are allowed
  • •5\.Uncontrolled tumor\-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to randomization. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain should be considered for loco\-regional therapy if appropriate prior to randomization
  • •6\.Ionized calcium \> 1\.2 x UNL.
  • •7\.Pregnant or breastfeeding
  • •8\.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
  • •9\.Significant cardiovascular disease. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF \< 50% must be on a stable medical regimen that is optimized
  • •10\.Severe infection within 21 days prior to randomization, requiring hospitalization

Outcomes

Primary Outcomes

Not specified

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