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A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer

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

NCT02685306•Peregrine Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+4 more criteria

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
+4 more criteria

Key Dates

Start Date

March 1, 2016

Primary Completion Date

April 1, 2017

Completion Date

September 1, 2017

Last Updated

March 9, 2017

Conditions

Breast CancerTriple Negative Breast NeoplasmsTriple-Negative Breast NeoplasmTriple-Negative Breast CancerTriple Negative Breast CancerER-Negative PR-Negative HER2-Negative Breast NeoplasmsER-Negative PR-Negative HER2-Negative Breast Cancer

Interventions

Bavituximab

BIOLOGICAL

Taxane

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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