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Breast CancerPhase 2NCT00866905

Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer

A Phase 2 study testing Ixabepilone and Cyclophosphamide in people with Breast Cancer, run by SCRI Development Innovations, LLC at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ixabepilone and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
20 sitesUnited States
Study dates
Apr 2009to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients, age ≥18 years.
  • Histologically confirmed invasive adenocarcinoma of the breast.
  • Primary palpable disease confined to a breast and axilla on
  • physical examination. For patients without clinically suspicious
  • axillary adenopathy, the primary tumor must be larger than 2 cm
  • in diameter by physical exam or imaging studies (clinical T2-T3,
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  • N0-N1, M0). For patients with clinically suspicious axillary
  • adenopathy, the primary breast tumor can be any size (clinical
  • T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
  • Patients without clearly defined palpable breast mass or axillary
  • lymph nodes but radiographically measurable tumor masses are
  • acceptable. Accepted procedures for measuring breast disease
  • are mammography, MRI, and breast ultrasound. This will need to
  • be re-evaluated after 3 cycles and prior to surgery.
  • Eastern Cooperative Oncology Group performance status (ECOG
  • PS) 0-2.
  • No metastatic disease, as documented by complete staging workup
  • 6 weeks prior to initiation of study treatment.
  • No previous treatment for breast cancer.
  • HER2-negative tumor status. HER2-negative is defined as:
  • Immunohistochemical (IHC) 0, IHC 1+ OR
  • IHC 2+ or IHC 3+ must be confirmed as FISH (fluorescence in situ
  • hybridization) negative (defined by ratio <2.2).
  • Adequate hematologic function with:
  • Absolute neutrophil count (ANC) >1500/μL.
  • Platelets ≥100,000/μL.
  • Hemoglobin ≥10 g/dL.
  • Adequate hepatic function with:
  • Serum bilirubin ≤ the institutional upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) ≤2.5 x institutional ULN.
  • Alanine aminotransferase (ALT) ≤2.5 x institutional ULN.
  • Adequate renal function with serum creatinine ≤1.5 x ULN.
  • Estrogen and progesterone receptor status in the primary tumor
  • known or pending at the time of study registration.
  • Knowledge of the investigational nature of the study and ability to
  • provide consent for study participation.
  • For patients who had, or will have sentinel lymph node and/or
  • axillary dissection prior to initiation of study treatment, completion
  • at least 4 weeks prior to starting study treatment and well-healed
  • wound
  • Bilateral, synchronous breast cancer is allowed if one primary
  • tumor meets the inclusion criteria.
  • Sufficient archived breast tumor specimen available at baseline
  • for the Oncotype DX assay.
  • -

Who cannot join

  • Inflammatory breast cancer.
  • Peripheral neuropathy (motor or sensory) ≥ grade 1 by the
  • Common Terminology Criteria for Adverse Events version 3.0
  • (CTCAE v 3.0).
  • Prior radiation that included ≥30% of major bone marrow containing
  • areas (pelvis, lumbar, spine).
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  • Chronic use of cytochrome P450 (CYP) 3A4 inhibitors and use of
  • the following strong CYP3A4 inhibitors: ketoconazole,
  • itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir,
  • telithromycin, ritonavir, amprenavir, indinavir, nelfinavir,
  • delavirdine, and voriconazole. Use of these agents should be
  • discontinued at least 72 hours prior to initiation of study treatment.
  • Chemotherapy within 5 years of starting study treatment except
  • for low doses of agents used for anti-inflammatory indications
  • such as rheumatoid arthritis, psoriasis, and connective tissue
  • disorders. Although such doses and schedules cannot result in
  • myelosuppression, patients must discontinue this therapy while
  • they are receiving study treatment.
  • Known or suspected hypersensitivity to Cremophor®EL
  • (polyoxyethylated castor oil) or a drug formulated in
  • Cremophor®EL such as paclitaxel, or any other agent given in the
  • course of this study.
  • Pregnancy or breast-feeding. A negative serum pregnancy test
  • within 7 days prior to first study treatment (Day 1, Cycle 1) for all
  • women of childbearing potential is required. Patients of
  • childbearing potential must agree to use a birth control method
  • that is approved by their study physician while receiving study
  • treatment and for 3 weeks after their last dose of study treatment.
  • Patients must agree to not breast-feed while receiving study
  • treatment.
  • Concurrent treatment with an ovarian hormonal replacement
  • therapy or with hormonal agents such as raloxifene, tamoxifen or
  • other selective estrogen receptor modulator (SERM). Patients
  • must have discontinued use of such agents prior to beginning
  • study treatment.
  • History of malignancy treated with curative intent within the
  • previous 5 years with the exception of skin cancer, cervical
  • carcinoma in situ, or follicular thyroid cancer. Patients with
  • previous invasive cancers (including breast cancer) are eligible if
  • the treatment was completed more than 5 years prior to initiating
  • current study treatment, and there is no evidence of recurrent
  • disease.
  • Uncontrolled intercurrent illness including (but not limited to)
  • ongoing or active infection.
  • Chronic treatment with corticosteroid unless treatment was begun
  • >6 months prior to study treatment and is at a low dose (≤20 mg
  • methylprednisolone or equivalent).
  • Use of any investigational agent within 30 days of administration
  • of the first dose of study drug.
  • Requirement for radiation therapy concurrent with neoadjuvant
  • study chemotherapy.
  • Concurrent treatment with any anti-cancer therapy other than
  • those agents used in this study.
  • Inability or unwillingness to comply with study procedures
  • including follow-up visits.
  • Mental condition or psychiatric disorder that would prevent patient
  • comprehension of the nature, scope, and possible consequences
  • of the study or that would limit compliance with study
  • requirements.
  • Any other disease(s), metabolic dysfunction, or findings from a
  • physical examination or clinical laboratory test result that would
  • cause reasonable suspicion of a disease or condition that
  • contraindicates the use of study drugs, that may affect the
  • interpretation of the results, or that renders the patient at high risk
  • from treatment complications
  • -

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Aventura Medical Center

    Aventura, Florida, 33180

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • National Capital Clinical Research Consortium

    Bethesda, Maryland, 20817

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Family Cancer Center

    Collierville, Tennessee, 38017

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Mercy Hospital

    Portland, Maine, 04101

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • South Texas Oncology and Hematology

    San Antonio, Texas, 78258

  • Providence Medical Group

    Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical

studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Read the detailed description

In this study, patients with early stage, HER2-negative breast cancer will receive neoadjuvant treatment with ixabepilone and cyclophosphamide given every three weeks for a total of six cycles. Following surgery patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Patients may receive local regional radiation therapy after surgery per institutional guidelines at the investigator's discretion. Baseline tumor tissue and tumor tissue removed at the time of surgery will be tested by Oncotype Detailed Description (DX) assay to determine whether it is predictive of response to this neoadjuvant treatment regimen. This study will be one of the first investigations of the combination of ixabepilone and cyclophosphamide as neoadjuvant treatment for HER2-negative breast cancer. It will examine this treatment regimen for potential advantages gained from substitution of ixabepilone for a taxane and use of non-anthracycline agents.

Conditions
Breast Cancer
Being tested
Ixabepilone, Cyclophosphamide
Keywords
Breast Cancer, Ixabepilone, Ixempra, Cyclophosphamide, Cytoxan, Neoadjuvant Therapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • IxabepiloneDrug

    Also called Systemic therapy, Ixempra

    40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles

  • CyclophosphamideDrug

    Also called Systemic therapy, Cytoxan

    600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles

Study groups in NCT00866905
Study groupRoleWhat they receive
Ixabepilone/CyclophosphamideExperimentalSystemic Therapy followed by surgery and possible radiation therapy
Receives: Drug: Ixabepilone; Drug: Cyclophosphamide

What is being measured

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

  1. Pathologic Complete Response Rate (pCR)

    Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.

    Measured: 6 months

Secondary outcomes (3)

  1. Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain

    Non hematologic treatment-related grade 4 toxicities measured according to CTCAE 3.0

    Measured: 3 months

  2. Overall Survival

    Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause. The percentage of patients who were alive at 3 years, estimated by Kaplan Meier method as the probability of being event free at 3 years is reported here.

    Measured: 36 months

  3. Disease Free Survival

    Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.

    Measured: 36 Months

Timeline

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

  1. First posted23 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2014
  4. Study completionOct 2014

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866905
Sponsor's protocol ID
SCRI BRE 133
Status last verified
Nov 2021
First submitted
19 Mar 2009
Last updated
22 Nov 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixabepilone and Cyclophosphamide in people with Breast Cancer, run by SCRI Development Innovations, LLC at 20 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 45 inclusion and 66 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: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 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?

Yes. Results are posted in the registry (first posted 27 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pathologic Complete Response Rate (pCR) (time frame: 6 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 NCT00866905.

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 22 Nov 2021.

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