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Metastatic Breast CancerPhase 2/3NCT02651610

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

A Phase 2/3 study testing Bavituximab and Taxane in people with Metastatic Breast Cancer, run by Peregrine Pharmaceuticals at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Bavituximab and Taxane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Dec 2015to Jun 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent obtained prior to screening.
  • Females or males at least 18 years of age.
  • Histologically or cytologically documented metastatic HER2-negative breast cancer.
  • Measurable disease per RECIST 1.1 (Phase II); evaluable disease (Phase III)
  • ECOG performance status of 0 or 1.
  • Adequate hematologic function: absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL.
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  • Adequate renal function: serum creatinine ≤1.8 mg/dL or calculated creatinine clearance >50 mL/min using the Cockcroft-Gault equation.
  • 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.
  • 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).
  • 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).
  • 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).

Who cannot join

  • HER2-positive breast cancer.
  • Less than 6 months since last dose of prior adjuvant non-taxane regimen.
  • Less than 12 months since last dose of prior adjuvant taxane-containing regimen.
  • Any chemotherapy regimen for MBC within 3 weeks before Day 1.
  • Known history of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia).
  • Bleeding:
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  • 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.
  • Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening.
  • Grade 2 or higher peripheral neuropathy (eg, numbness, tingling, and/or pain in distal extremities).
  • Radiotherapy within 1 week preceding Day 1; ongoing acute toxicity from prior radiotherapy.
  • 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).
  • Major surgery within 4 weeks of Day 1.
  • Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease, active infections).
  • Autoimmune disease, being treated with immunosuppressive drugs (eg, methotrexate or biological agents), or other conditions requiring immunosuppressive therapy (eg, prior allotransplantation).
  • History of hypersensitivity to bavituximab, docetaxel, paclitaxel, or to any of their excipients.
  • Symptomatic coronary artery disease, cerebrovascular accident or transient ischemic attack, myocardial infarction, arterial embolism, or unstable angina pectoris within 6 months of screening.
  • Currently pregnant, nursing, or planning a pregnancy during the study.
  • Investigational therapy within 28 days prior to Day 1.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Peregrine Pharmaceuticals Investigational Site

    Bakersfield, California, 93309

  • Peregrine Pharmaceuticals Investigational Site

    Tinley Park, Illinois, 60487

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Bavituximab, Taxane
Keywords
PPHM 1401, bavituximab, Peregrine, Breast Cancer, HER-2 Negative, HER2 Negative
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BavituximabBiological

    Biological: bavituximab

  • TaxaneDrug

    Also called Paclitaxel, Taxotere, Docetaxel, Docecad

    Drug: Taxane Other names: Paclitaxel. Taxotere, Taxotere, Docecad, Taxol

Study groups in NCT02651610
Study groupRoleWhat they receive
TaxaneActive comparatorDocetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
Receives: Drug: 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
Receives: Biological: Bavituximab; Drug: Taxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Measured: 24 months

Secondary outcomes (5)

  1. Safety Measures - Adverse Events and Laboratory Evaluations

    Measured: 24 months

  2. Efficacy: Disease Control Rate (DCR)

    Measured: 24 Months

  3. Efficacy: Duration of Response (DOR)

    Measured: 24 Months

  4. Efficacy: Progression Free Survival (PFS)

    Measured: 24 Months

  5. Efficacy: Overall Survival

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651610
Sponsor's protocol ID
PPHM 1401
Other IDs
2015-003780-11, 2015
Status last verified
Jul 2017
First submitted
29 Dec 2015
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bavituximab and Taxane in people with Metastatic Breast Cancer, run by Peregrine Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02651610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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