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Phase II Study of FTD/TPI (Lonsurf) in Metastatic Breast Cancers With or Without Prior Exposure to Fluoropyrimidines (LONBRECA)

Recruiting
21 - 99 years of age
Both
Phase 1/2

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Overview

This is a single arm, open-label, lead in phase Ib dose confirmation, followed by phase II study with 2 parallel study cohorts.

Description

Phase Ib Patients will be treated with twice-daily dosing of FTD/TPI in a 3+3 dose escalation design Phase II

Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.

2 parallel cohorts of patients will be enrolled : Cohort A : patients with prior exposure to fluoropyrimidines Cohort B : patients without prior exposure to fluoropyrimidines

Eligibility

Inclusion Criteria:

  • Age ≥ 21 years.
  • Histological or cytological diagnosis of breast carcinoma.
  • ECOG 0-2.
  • HER2 negative tumor (IHC 0 -1+ or IHC 2+ and confirmed on HER2 FISH to be negative based on histological report).
  • Patients with HER2 positive tumor may be enrolled if they have failed at least two lines of anti-HER2 based therapies in the metastatic setting, or are intolerant to trastuzumab
  • Any hormone receptor status.
  • Any number of lines of prior palliative endocrine therapy for patients with hormone receptor positive cancer.
  • Has measureable or evaluable disease based on RECIST 1.1 criteria
  • Estimated life expectancy of at least 12 weeks.
  • Has documented progressive disease from last line of therapy.
  • Has recovered from acute toxicities from prior anti-cancer therapies
  • Adequate organ function including the following:
        oBone marrow: (I) Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L (ii)
        Platelets ≥100 x 109/L (ii) Hemoglobin ≥8 x 109/L oHepatic: (I)Bilirubin ≤ 1.5 x upper
        limit of normal (ULN), (ii)ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases) oRenal:
        (I) Creatinine ≤1.5x ULN
          -  Signed informed consent from patient or legal representative.
          -  Able to comply with study-related procedures.
          -  Prior therapy (patients enrolled in phase Ib may be enrolled if they fulfil prior
             therapy criteria for either Cohort A or Cohort B)
               -  Cohort A only: Has received at least 2 lines of palliative systemic therapy,
                  including prior fluropyrimidines (capecitabine, TS-1 or 5-fluorouracil) in the
                  palliative setting, or in the adjuvant setting; patients who have only prior
                  exposure to adjuvant fluoropyrimidines must have relapsed within 12 months of
                  completing adjuvant fluoropyrimidines
               -  Cohort B only: Any number of prior lines of palliative chemotherapy and has not
                  received fluoropyrimidines (capecitabine, TS-1 or 5-fluorouracil) in the
                  palliative setting or in the adjuvant setting; patients who have prior exposure
                  to adjuvant fluoropyrimidines are eligible if they have relapsed 12 months from
                  completion of adjuvant fluoropyrimidines.
        Exclusion Criteria:
          -  Treatment within the last 30 days with any investigational drug.
          -  Concurrent administration of any other tumour therapy, including cytotoxic
             chemotherapy, hormonal therapy, and immunotherapy.
          -  Major surgery within 28 days of study drug administration.
          -  Active infection that in the opinion of the investigator would compromise the
             patient's ability to tolerate therapy.
          -  Pregnancy.
          -  Breast feeding.
          -  Serious concomitant disorders that would compromise the safety of the patient or
             compromise the patient's ability to complete the study, at the discretion of the
             investigator.
          -  Active bleeding disorder or bleeding site.
          -  Non-healing wound.
          -  Poorly controlled diabetes mellitus.
          -  Second primary malignancy that is clinically detectable at the time of consideration
             for study enrollment.
          -  Symptomatic brain metastasis.
          -  History of significant neurological or mental disorder, including seizures or
             dementia.
          -  Unable to comply with study procedures
        Phase Ib lead-in can recruit patients who fulfil criteria for either Cohort A or Cohort B
        AND all other inclusion/exclusion criteria

Study details

Breast Cancer

NCT04280536

National University Hospital, Singapore

25 January 2024

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