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ClinicalTrial.gov Identifier : NCT01506609

The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer

    Status Active, not recruiting
    Related Conditions
    Metastatic Breast Cancer

Enrollment Details

294 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M12-895

Brief summary

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The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 4

0
Toronto, ON
1
Montreal, QC
2
Quebec, QC
3
Montreal, QC
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Investigator)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
    • Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
    • Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
    • If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
    • Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
    • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
    • Subject must have adequate bone marrow, renal and hepatic function.
    • Subject must not be pregnant or plan to conceive a child.
    • Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1
    • More than 2 prior lines of cytotoxic chemotherapy
    • Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
    • Prior taxane therapy for metastatic breast cancer.
    • A history of or evidence of brain metastases or leptomeningeal disease.
    • A history of uncontrolled seizure disorder
    • Pre-existing neuropathy from any cause in excess of Grade 1
    • Known history of allergic reaction to cremophor/paclitaxel
    • Clinical significant uncontrolled conditions â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
    • Pregnant or breastfeeding

More on this trial

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