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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651610
Recruitment Status : Withdrawn
First Posted : January 11, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Biological: Bavituximab Drug: Taxane Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Taxane
Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
Drug: Taxane
Drug: Taxane Other names: Paclitaxel. Taxotere, Taxotere, Docecad, Taxol
Other Names:
  • Paclitaxel
  • Taxotere
  • Docetaxel
  • Docecad
  • Taxol

Experimental: Bavituximab plus taxane
Bavituximab 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
Biological: Bavituximab
Biological: bavituximab

Drug: Taxane
Drug: Taxane Other names: Paclitaxel. Taxotere, Taxotere, Docecad, Taxol
Other Names:
  • Paclitaxel
  • Taxotere
  • Docetaxel
  • Docecad
  • Taxol




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Safety Measures - Adverse Events and Laboratory Evaluations [ Time Frame: 24 months ]
  2. Efficacy: Disease Control Rate (DCR) [ Time Frame: 24 Months ]
  3. Efficacy: Duration of Response (DOR) [ Time Frame: 24 Months ]
  4. Efficacy: Progression Free Survival (PFS) [ Time Frame: 24 Months ]
  5. Efficacy: Overall Survival [ Time Frame: 24 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651610


Locations
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United States, California
Peregrine Pharmaceuticals Investigational Site
Bakersfield, California, United States, 93309
United States, Illinois
Peregrine Pharmaceuticals Investigational Site
Tinley Park, Illinois, United States, 60487
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
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Study Chair: Kathy Miller, MD Indiana University School of Medicine
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Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651610    
Other Study ID Numbers: PPHM 1401
2015-003780-11 ( EudraCT Number )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by Peregrine Pharmaceuticals:
PPHM 1401
bavituximab
Peregrine
Breast Cancer
HER-2 Negative
HER2 Negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Taxane
Bavituximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological