Clinical Trials /

Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

NCT02651610

Description:

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
  • Official Title: An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: PPHM 1401
  • SECONDARY ID: 2015-003780-11
  • NCT ID: NCT02651610

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
BavituximabBavituximab plus taxane
TaxanePaclitaxel, Taxotere, Docetaxel, Docecad, TaxolTaxane

Purpose

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast cancer.

Detailed Description

      This is an open-label randomized trial in patients with HER2-negative metastatic breast
      cancer. Patients will be treated with either taxane alone (investigator choice of paclitaxel
      or docetaxel) or taxane with bavituximab. Paclitaxel will be given 3 of 4 weeks, docetaxel
      will be given once every 3 weeks, and bavituximab will be given weekly. All therapy will
      continue until disease progression, toxicity, withdrawal or consent, investigator decision,
      or study termination. Efficacy (overall response rate) is the primary endpoint while safety
      is the secondary endpoint.
    

Trial Arms

NameTypeDescriptionInterventions
TaxaneActive ComparatorDocetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
  • Taxane
Bavituximab plus taxaneExperimentalBavituximab 3 mg/kg weekly PLUS Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
  • Taxane

Eligibility Criteria

        Inclusion Criteria

          1. Written informed consent obtained prior to screening.

          2. Females or males at least 18 years of age.

          3. Histologically or cytologically documented metastatic HER2-negative breast cancer.

          4. Measurable disease per RECIST 1.1 (Phase II); evaluable disease (Phase III)

          5. ECOG performance status of 0 or 1.

          6. Adequate hematologic function: absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9
             g/dL; platelets ≥100,000/µL.

          7. Adequate renal function: serum creatinine ≤1.8 mg/dL or calculated creatinine
             clearance >50 mL/min using the Cockcroft-Gault equation.

          8. Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum
             albumin ≥3.0 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
             ≤1.5 × ULN. ALT and/or AST may be ≤5 × ULN if due to liver metastases. If ALT or AST
             is >1.5 and ≤5 × ULN in patients with liver metastases, alkaline phosphatase must be
             ≤2.5 × ULN. Patients with Gilbert's syndrome are allowed if total bilirubin is ≤2 ×
             ULN and direct bilirubin is ≤ULN.

          9. Prothrombin time (PT) and/or international normalized ratio (INR) ≤1.5 × ULN and
             activated partial thromboplastin time (aPTT) ≤1.5 × ULN if patient is not on
             anticoagulant therapy (a therapeutic PT and/or INR and aPTT is acceptable if the
             patient is on anticoagulants).

         10. Patients must have a negative serum human chorionic gonadotropin test within 1 week of
             Day 1 (pregnancy test not required for patients with bilateral oophorectomy and/or
             hysterectomy or for those patients who are >1 year postmenopausal).

         11. All patients of reproductive potential (ie, not surgically sterile or postmenopausal)
             must agree to use a highly effective method of contraception (<1% failure rate per
             year) during and 3 months after end of study treatment (female) or during and 6 months
             after the end of study treatment (male).

        Exclusion Criteria

          1. HER2-positive breast cancer.

          2. Less than 6 months since last dose of prior adjuvant non-taxane regimen.

          3. Less than 12 months since last dose of prior adjuvant taxane-containing regimen.

          4. Any chemotherapy regimen for MBC within 3 weeks before Day 1.

          5. Known history of bleeding diathesis or coagulopathy (eg, von Willebrand disease or
             hemophilia).

          6. Bleeding:

               -  Clinically significant bleeding, such as gross hematuria, gastrointestinal
                  bleeding, and hemoptysis within the 6 months before screening, unless the cause
                  has been identified and adequately treated (eg, cystitis, ulcer).

               -  Minor biopsy-related bleeding lasting <24 hours and resolved at least 1 week
                  before Day 1 is allowed.

          7. Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial
             thrombosis) within 6 months before screening.

          8. Grade 2 or higher peripheral neuropathy (eg, numbness, tingling, and/or pain in distal
             extremities).

          9. Radiotherapy within 1 week preceding Day 1; ongoing acute toxicity from prior
             radiotherapy.

         10. Either symptomatic or clinically active brain metastases (ie, requiring ongoing
             treatment). Patients are eligible if brain metastases are adequately treated. Patients
             must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily
             prednisone (or equivalent).

         11. Major surgery within 4 weeks of Day 1.

         12. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease, active
             infections).

         13. Autoimmune disease, being treated with immunosuppressive drugs (eg, methotrexate or
             biological agents), or other conditions requiring immunosuppressive therapy (eg, prior
             allotransplantation).

         14. History of hypersensitivity to bavituximab, docetaxel, paclitaxel, or to any of their
             excipients.

         15. Symptomatic coronary artery disease, cerebrovascular accident or transient ischemic
             attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6
             months of screening.

         16. Currently pregnant, nursing, or planning a pregnancy during the study.

         17. Investigational therapy within 28 days prior to Day 1.

         18. Patient has a condition or is in a situation which, in the investigator's opinion, may
             put the patient at significant risk, may confound the study results, or may interfere
             significantly with the patient's participation in the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Safety Measures - Adverse Events and Laboratory Evaluations
Time Frame:24 months
Safety Issue:
Description:
Measure:Efficacy: Disease Control Rate (DCR)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Efficacy: Duration of Response (DOR)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Efficacy: Progression Free Survival (PFS)
Time Frame:24 Months
Safety Issue:
Description:
Measure:Efficacy: Overall Survival
Time Frame:24 Months
Safety Issue:
Description:

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:Peregrine Pharmaceuticals

Trial Keywords

  • PPHM 1401
  • bavituximab
  • Peregrine
  • Breast Cancer
  • HER-2 Negative
  • HER2 Negative

Last Updated

July 7, 2017