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A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative 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. Identifier: NCT02685306
Recruitment Status : Withdrawn
First Posted : February 18, 2016
Last Update Posted : March 9, 2017
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 early- stage Triple Negative Breast Cancer followed by Standard- of- Care surgery

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Neoplasms Triple-Negative Breast Neoplasm Triple-Negative Breast Cancer Triple Negative Breast Cancer ER-Negative PR-Negative HER2-Negative Breast Neoplasms ER-Negative PR-Negative HER2-Negative Breast Cancer Biological: Bavituximab Drug: Taxane Phase 2

Detailed Description:
This is an open-label randomized trial in patients with early- stage Triple Negative Breast Cancer. Patients will be treated with either paciltaxel alone or paclitaxel with bavituximab. Paclitaxel will be given weekly, and bavituximab will be given weekly. All therapy will continue for up to twelve doses of treatment followed by standard of care definitive surgical resection.

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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: A Phase II Study to Determine the Pathological Complete Response Rate and Immunomodulatory Effects of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: Taxane
Taxane (Paclitaxel) weekly on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
Drug: Taxane
12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
Other Name: Paclitaxel

Experimental: Bavituximab plus Taxane
Bavituximab 3 mg/kg weekly PLUS Taxane (Paclitaxel) on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
Biological: Bavituximab
12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78

Drug: Taxane
12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
Other Name: Paclitaxel

Primary Outcome Measures :
  1. Pathological Complete Response (pCR) rate of neoadjuvant paclitaxel in combination with bavituximab in patients with early- stage triple- negative breast cancer (TNBC) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Safety Measures - Adverse Events and Laboratory Evaluations [ Time Frame: approximately 24 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Written informed consent has been obtained prior to screening.
  2. Target Population

    1. Female or male at least 18 years of age.
    2. Invasive breast cancer confirmed by pathology evaluation of core biopsy.
    3. Early-stage TNBC according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage I (T1c, > 1.5 cm), Stage II or Stage III invasive breast cancer.
    4. Tumors must be ER/PgR status negative (IHC < 1%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH < 2.2) as described in the NCCN Guidelines.
    5. Patient must consent to a minimum of 1 tumor-containing formalin fixed paraffin embedded core (or archival tissue) or baseline research biopsy.
  3. Eastern Cooperative Oncology Group Performance Status 0 or 1.
  4. Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin > 9 g/dL, platelets > 100,000/µL.).
  5. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation).
  6. Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x ULN.
  7. Prothrombin time and/or international normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time ≤ 1.5 x ULN, if patient is not on anticoagulant therapy.
  8. Female 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
  9. Women of childbearing potential must avoid becoming pregnant and men must avoid fathering a child during and for 3 months after the end of study treatment.

Exclusion Criteria:

  1. Surgically unresectable, inflammatory, or metastatic breast cancer.
  2. Any prior treatment for current breast cancer including chemotherapy, hormonal therapy, radiation, or other experimental therapy.
  3. Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
  4. Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding before screening (if clinically significant bleeding has occurred within 6 months of screening, but the cause has been identified and adequately treated [e.g., cystitis, ulcer], then this exclusion criterion does not apply. Minor biopsy-related bleeding lasting < 24 hours and resolved at least 1 week before Day 1 is allowed.
  5. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or arterial thrombosis) occurring within 6 months before screening.
  6. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease, active infections).
  7. Autoimmune disease requiring treatment with chronic systemic immunosuppressive therapy. Prior allotransplantation.
  8. History of hypersensitivity to any of the excipients of paclitaxel (e.g., Cremaphor).
  9. Has an active infection requiring systemic therapy.
  10. Major surgery within 4 weeks prior to Day 1
  11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  12. Investigational therapy within 28 days prior to Day 1.
  13. Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial.
  14. Has a known history of human immunodeficiency virus (HIV) (HIV1/2 antibodies) or active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., hepatitis C virus RNA [qualitative] is detected.

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 identifier (NCT number): NCT02685306

Sponsors and Collaborators
Peregrine Pharmaceuticals
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Principal Investigator: David Page, MD Providence Portland / Robert W. Franz Cancer Research Center

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Responsible Party: Peregrine Pharmaceuticals Identifier: NCT02685306     History of Changes
Other Study ID Numbers: PPHM 1502
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs