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AzTrials

Breast CancerPhase 2NCT00777673

Preoperative Chemotherapy in Triple Negative Invasive Breast Cancer That Can be Removed by Surgery.

A Phase 2 study testing Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim in people with Breast Cancer, run by University of Tennessee Cancer Institute at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. 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?
Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim
Type of treatment
Injection or infusion
How many people
60 participants
Where
3 sitesUnited States
Study dates
Oct 2008to Oct 2013
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be female and ≥ 18 years of age.
  • ECOG performance status 0 or 1
  • Diagnosis of invasive adenocarcinoma of the breast must be made by a core needle biopsy. ER, PR and HER2 must be available on the initial diagnostic biopsy and must be negative. HER2 negativity is defined as 0 or 1+ staining on IHC or documented non amplification by FISH. Patients with 2+ staining on IHC must be non amplified by FISH. Patients with tumors determined to be 3+ on IHC or amplified for HER2 by FISH are ineligible.
  • Primary breast tumor must be ≥ 2cm and meet RECIST criteria for palpable measurable disease. Two synchronous tumors in the same breast are allowed, but one of them must be ≥ 2 cm and clinically palpable at baseline.
  • Patients must agree to submission of two additional core biopsy specimens for correlative studies.
  • A baseline cardiac ejection fraction ≥ lower limit of normal (LLN) for the imaging facility must be obtained within 21 days of study entry.
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  • EKG with no acute or significant abnormalities, obtained within 21 days of study entry.
  • Adequate hematologic, renal and hepatic function (ANC ≥ 1,500, platelet count ≥100,000, hemoglobin > 10, serum creatinine ≤ upper limit of nor (ULN) for the institution, total bilirubin ≤ 1.5 mg/dL, and AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2 x ULN) obtained within 21 days of study entry.
  • Urine protein/urine creatinine (UPC) ratio must be < 1.0. Patients discovered to have a UPC > 1.0 at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible.
  • Patients with reproductive potential must use an effective method of contraception to avoid pregnancy for the duration of the trial.
  • If female of child bearing potential, pregnancy test must be documented as negative.

Who cannot join

  • Patients with documented metastatic disease are ineligible.
  • Patients with tumors clinically staged as T4, including inflammatory cancer are ineligible.
  • Patients with ipsilateral cN2b or cN3 disease are ineligible. (cN1 or cN2a disease are eligible)
  • Patients who have had any prior chemotherapy, radiation therapy, hormonal or biologic therapy for the currently diagnosed breast cancer prior to study entry are ineligible.
  • Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.)
  • Patients with any major surgery, open biopsy or significant traumatic injury within 28 days prior to study entry or anticipation of major surgery during the study other than their definitive breast surgery are ineligible.
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  • Patients with surgical axillary staging prior to study entry are ineligible. FNA of clinically palpable nodes is permissible. Although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permissible.
  • Patients must not have a significant history of cardiac disease (congestive heart failure New York Heart association (NYHA) Grade II or greater, uncontrolled hypertension {defined as BP > 150/90 on antihypertensive therapy. Patients with hypertension that is well controlled on medication are eligible.} unstable angina, myocardial infarction or ventricular arrhythmias requiring medications within 12 months prior to study entry. Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Patients with a prior history of TIA, CVA or other arterial thrombotic events prior to study entry are ineligible.
  • Patients with significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease are ineligible.
  • Patients with any significant non traumatic bleeding within 6 months prior to study entry are ineligible.
  • Patients with serious or non healing wound, skin ulcers or incompletely healed bone fractures are ineligible.
  • Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment are ineligible.
  • Patient with known bleeding diathesis or coagulopathy are ineligible. Patients on a stable dose of warfarin with a therapeutic INR between 2 and 3 are eligible.
  • Patients with sensory or motor neuropathy ≥ grade 2 (NCI Common toxicity criteria adverse events version 3.0) are ineligible.
  • No prior malignancy is allowed with the exception of treated basal or squamous cell carcinomas of the skin, cervical cancer in situ, or any other cancer provided that the patient has been disease free for ≥ 5 years.
  • Other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with any of the treatment regimens or would prevent required follow-up.
  • Patients with known infection with HIV, HBV or HCV are ineligible.
  • Patients with psychosocial conditions that preclude medical follow up and compliance with the treatment protocol are ineligible.
  • Patients with known hypersensitivity to any of the study drugs are ineligible.
  • Administration of any investigational agents within 30 days before study entry.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38104

  • The West Clinic

    Memphis, Tennessee, 38120

Other trials in United States

About this study

Official title: Neoadjuvant Weekly Nab-paclitaxel (Abraxane®) Plus Carboplatin Followed By Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently To Chemotherapy For Palpable And Operable Triple Negative Invasive Breast Cancer

The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.

Conditions
Breast Cancer
Being tested
Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim
Keywords
Breast Cancer, Triple Negative, Neoadjuvant, Neoadjuvant therapy, ER, PR and 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.

  • Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-FilgrastimDrug

    Eligible patients will receive:

    • nab-paclitaxel IV on days 1, 8, and 15. Treatment will be repeated every 28 days 28 days for 4 courses.
    • Carboplatin IV on day 1. Treatment will be repeated every 28 days for 4 courses.
    • Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 4 courses.

    After completion of the above regimen, patients will receive:

    • Doxorubicin IV on day 1. Treatment will be repeated every 14 days for 4 courses.
    • Cyclophosphamide IV on day 1. Treatment will be repeated every 14 days for 4 courses.
    • Bevacizumab IV on day 1. Treatment will be repeated every 14 days for 2 courses.

    Patients will then proceed with:

    • Surgery including axillary staging

    A minimum of 4 weeks post operatively, patient will receive:

    • Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses.

What is being measured

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

  1. Pathological complete response (pCR) in the breast

    Measured: No interim efficacy analysis is planned. It is anticipated that the definitive analysis would be performed approximately 3 years after initiation of accrual (2 years to accrue 60 patients plus one additional year of follow up)

Secondary outcomes (1)

  1. Rate of near pCR/pCR of breast, axillary Ns & non axillary SNs cRR with nab-paclitaxel + carbo with bev cRR post neoadj Tx Rate of breast conserving surgery Safety & tolerability Disease free survival Identify gene(s) that may predict pCR to Tx

    Measured: Approximately 3 years from study initiation

Timeline

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

  1. First posted22 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2013 (estimated)
  4. Study completionOct 2013 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00777673
Sponsor's protocol ID
BRE 01-08
Status last verified
Jan 2013
First submitted
20 Oct 2008
Last updated
4 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim in people with Breast Cancer, run by University of Tennessee Cancer Institute at 3 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 22 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: status not confirmed, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Results are not available in the source record.

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) in the breast (time frame: No interim efficacy analysis is planned. It is anticipated that the definitive analysis would be performed approximately 3 years after initiation of accrual (2 years to accrue 60 patients plus one additional year of follow up)). 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 NCT00777673.

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 4 Jan 2013.

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