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

Peregrine Pharmaceuticals0 sitesMarch 2016

ConditionsBreast 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

InterventionsTaxane Bavituximab

DrugsTaxane

Overview

Phase: Phase 2
Intervention: Taxane
Conditions: Breast Cancer
Sponsor: Peregrine Pharmaceuticals
Primary Endpoint: Pathological Complete Response (pCR) rate of neoadjuvant paclitaxel in combination with bavituximab in patients with early- stage triple- negative breast cancer (TNBC)
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

September 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peregrine Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent has been obtained prior to screening.
•Target Population
•Female or male at least 18 years of age.
•Invasive breast cancer confirmed by pathology evaluation of core biopsy.
•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.
•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.
•Patient must consent to a minimum of 1 tumor-containing formalin fixed paraffin embedded core (or archival tissue) or baseline research biopsy.
•Eastern Cooperative Oncology Group Performance Status 0 or
•Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin \> 9 g/dL, platelets \> 100,000/µL.).
•Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation).

Exclusion Criteria

•Surgically unresectable, inflammatory, or metastatic breast cancer.
•Any prior treatment for current breast cancer including chemotherapy, hormonal therapy, radiation, or other experimental therapy.
•Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
•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.
•Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or arterial thrombosis) occurring within 6 months before screening.
•Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease, active infections).
•Autoimmune disease requiring treatment with chronic systemic immunosuppressive therapy. Prior allotransplantation.
•History of hypersensitivity to any of the excipients of paclitaxel (e.g., Cremaphor).
•Has an active infection requiring systemic therapy.
•Major surgery within 4 weeks prior to Day 1

Arms & Interventions

Taxane

Taxane (Paclitaxel) weekly on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78

Intervention: Taxane

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

Intervention: Bavituximab

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

Intervention: Taxane

Outcomes

Primary Outcomes

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