Breast CancerPhase 2NCT02685306
A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer
A Phase 2 study testing Bavituximab and Taxane in people with Breast Cancer and Triple Negative Breast Neoplasms, run by Peregrine Pharmaceuticals.
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 early- stage Triple Negative Breast Cancer followed by Standard- of- Care surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Neoplasms, Triple-Negative Breast Neoplasm
- What is being tested?
- Bavituximab and Taxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2017
- Phase
- Phase 2
- 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 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.
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- 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 1.
- 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).
- 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.
- 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.
- 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
- 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.
Who cannot join
- 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).
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- 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
- 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.
- Investigational therapy within 28 days prior to Day 1.
- Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial.
- 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.
About this study
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
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
Read the 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.
- Conditions
- 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
- Being tested
- Bavituximab, Taxane
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BavituximabBiological
12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
TaxaneDrug
Also called Paclitaxel
12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
| Study group | Role | What they receive |
|---|---|---|
| Taxane | Active comparator | Taxane (Paclitaxel) weekly on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 Receives: Drug: Taxane |
| Bavituximab plus Taxane | Experimental | Bavituximab 3 mg/kg weekly PLUS Taxane (Paclitaxel) on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 Receives: Biological: Bavituximab; Drug: Taxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate of neoadjuvant paclitaxel in combination with bavituximab in patients with early- stage triple- negative breast cancer (TNBC)
Measured: Approximately 24 months
Secondary outcomes (1)
Safety Measures - Adverse Events and Laboratory Evaluations
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Page, MD, Principal investigator, Providence Portland / Robert W. Franz Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685306
- Sponsor's protocol ID
- PPHM 1502
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02685306
- Acronym / sponsor ID
- PPHM 1502
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxane | Active comparator | Drug: TaxaneTaxane (Paclitaxel) weekly on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 |
| Bavituximab plus Taxane | Experimental | Biological: Bavituximab, Drug: TaxaneBavituximab 3 mg/kg weekly PLUS Taxane (Paclitaxel) on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent has been obtained prior to screening.
- Target Population
- Eastern Cooperative Oncology Group Performance Status 0 or 1.
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bavituximab12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 | Biological | Bavituximab plus Taxane |
| TaxaneAlso: Paclitaxel12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78 | Drug | Bavituximab plus Taxane, Taxane |
Primary outcome
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
1 secondary outcome
Safety Measures - Adverse Events and Laboratory Evaluations
Time frame: approximately 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Page, MD principal investigator
Providence Portland / Robert W. Franz Cancer Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bavituximab and Taxane in people with Breast Cancer and Triple Negative Breast Neoplasms, run by Peregrine Pharmaceuticals.
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 14 inclusion and 14 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2017.