AzTrials
AzTrials

Breast NeoplasmsPhase 2NCT00110695

Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer

A Phase 2 study testing Nanoparticle albumin bound paclitaxel followed by FEC in people with Breast Neoplasms, run by NSABP Foundation Inc at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Nanoparticle albumin bound paclitaxel followed by FEC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Apr 2005to Jul 2008
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

  • Signed consent
  • Diagnosis made by core biopsy or incisional biopsy
  • Histologic confirmation of invasive breast cancer
  • Clinical staging as IIB (cT3N0 only), IIIA (cT3N1 or cT0-3N2), or IIIB (cT4N0-2)
  • ECOG performance 0 or 1
  • At the time of entry: *Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; *platelet count must be greater than or equal to 100,000/mm3; *hemoglobin must be greater than or equal to 10 g/dl; *serum creatinine must be less than or equal to ULN for the lab.
Show all 9Show fewer
  • The following criteria for evidence of adequate hepatic function must be met: *Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and *alkaline phosphatase must be < 2.5 x ULN for the lab; and
  • AST must be less than or equal to 1.5 x ULN for the lab.
  • MUGA scan or echocardiogram within 3 months prior to entry if: *age greater than or equal to 60, or *history of hypertension, or *plan to receive trastuzumab. For any patient who has a MUGA scan or echocardiogram performed for any reason, the baseline LVEF must be greater than or equal to LLN for the facility performing the procedure and there must be no regional wall abnormalities

Who cannot join

  • Clinical stage IIB disease that is cT2N1.
  • Definitive evidence of metastatic disease (M1 by AJCC criteria)
  • Prior history of invasive breast cancer in either breast or ductal carcinoma in situ (DCIS) in the ipsilateral breast treated with radiation therapy (patients with a history of lobular carcinoma in situ [LCIS] are eligible).
  • Any treatment for the currently diagnosed breast cancer prior to study entry including radiation therapy, chemotherapy, and/or hormonal therapy.
  • Pregnancy or lactation at the time of study entry.
  • Prior anthracycline or taxane-containing chemotherapy for any malignancy.
Show all 13Show fewer
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up.
  • Grade 2 or greater peripheral polyneuropathy at the time of entry.
  • Cardiac disease that would preclude the use of anthracyclines or trastuzumab. This includes:
  • myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; angina pectoris that requires the use of anti-anginal medication; any history of documented congestive heart failure; serious cardiac arrhythmia requiring medication; severe conduction abnormality; valvular disease with documented cardiac function compromise; or uncontrolled hypertension defined as blood pressure > 160/100 mm/Hg.
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.) Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  • 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.
  • Use of any investigational agent within the month before enrollment in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NSABP Operations Center

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

Official title: A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer

The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.

Read the detailed description

This is a Phase 2, non-randomized study of neoadjuvant treatment with nanoparticle albumin bound paclitaxel (Abraxane) every week for 12 weeks followed by 5-FU, epirubicin, and cyclophosphamide (FEC) every 3 weeks for 4 cycles in women with locally advanced breast cancer. Patients with HER-2 overexpressing breast cancer may receive trastuzumab concurrently with the chemotherapy at the discretion of the investigator. The primary aim of this study is to determine the pathologic complete response rate (pCR) of this sequential regimen.

Patients who achieve clinical complete response (cCR), clinical partial response (cPR), or have resectable stable disease (SD) will undergo surgery. Surgery will consist of modified radical mastectomy or excision of the primary tumor site with clear surgical margins accompanied by axillary staging. Tumor samples taken prior to initiation of treatment will be analyzed for molecular and genetic changes which will be correlated with tumor response.

Patients must have a histologically confirmed diagnosis of breast cancer without documented evidence of distant metastatic disease. Patients with clinical Stage IIB (T3N0 only), IIIA, or IIIB breast cancer will be potential candidates for this trial.

Being tested
Nanoparticle albumin bound paclitaxel followed by FEC
Keywords
NSABP, Abraxis, Abraxane, Locally advanced breast cancer, Fluorouracil, Epirubicin, Cyclophosphamide, FEC
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Nanoparticle albumin bound paclitaxel followed by FECDrug

    Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. [or if given with trastuzumab 75 mg/m2 IV over 15 min.]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days

Study groups in NCT00110695
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Nanoparticle albumin bound paclitaxel followed by FEC

What is being measured

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

  1. pathologic complete response rate in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane

    Measured: pCR examined in breast tissue taken at surgery

Secondary outcomes (9)

  1. pathologic complete response rate in the breast and axillary nodes (pCR breast and nodes) in all patients

    Measured: pCR examined in breast and lymph node tissue taken at surgery

  2. complete clinical response rate (cCR) of the sequential regimen in patients who present with palpable measurable disease

    Measured: physical exam between the two chemotherapy regimens and at completion of the entire treatment regimen

  3. complete clinical and imaging response rate (ciCR) of the sequential regimen in all patients

    Measured: physical exam and breast imaging at 3-4 weeks after the last chemotherapy treatment

  4. complete clinical response rate (cCR)of Abraxane in patients who present with palpable measurable disease

    Measured: physical exam at completion of the Abraxane portion of the treatment regimen

  5. toxicity of the sequential chemotherapy regimen

    Measured: during treatment and for 3 to 4 weeks after the last chemotherapy cycle

  6. toxicity of the sequential chemotherapy regimen when administered concurrently with trastuzumab

    Measured: during treatment and for 3 to 4 weeks after the last chemotherapy cycle

  7. 2-year progression-free survival

    Measured: from the first dose of study therapy to first date of disease progression or for a maximum of 24 months from study entry

  8. 2-year overall survival (OS)

    Measured: from the first dose of study therapy to date of death or for a maximum of 24 months from study entry

  9. exploration of molecular and genetic correlates of response

    Measured: after specimen procurement and continuing after completion of clinical phase of study

Timeline

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

  1. First posted13 May 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionDec 2006
  4. Study completionJul 2008

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
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110695
Sponsor's protocol ID
NSABP FB-AX-003
Status last verified
Mar 2010
First submitted
12 May 2005
Last updated
26 Mar 2010
Results posted
No
Data monitoring committee
No

Publications

  • Robidoux A, Buyse M, Buzdar A, et al.: Neoadjuvant chemotherapy with sequential weekly nanoparticle albumin-bound paclitaxel (ABI-007, Abraxane®) followed by 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in locally advanced breast cancer (LABC): a phase II trial of the NSABP Foundation research program (FRP). [Abstract] Annual San Antonio Breast Cancer Symposium 3068, 2006.

  • Robidoux A, Buzdar AU, Quinaux E, Jacobs S, Rastogi P, Fourchotte V, Younan RJ, Pajon ER, Shalaby IA, Desai AM, Fehrenbacher L, Geyer CE Jr, Mamounas EP, Wolmark N. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.

    PubMed 20133263

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanoparticle albumin bound paclitaxel followed by FEC in people with Breast Neoplasms, run by NSABP Foundation Inc at 1 site 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 9 inclusion and 13 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 26 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in the breast for patients with locally advanced breast cancer (LABC) who receive Abraxane (time frame: pCR examined in breast tissue taken at surgery). 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 NCT00110695, which also lists 2 linked publications.

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 26 Mar 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in