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Breast CancerPhase 2NCT00629499

Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

A Phase 2 study testing nab paclitaxel, Cyclophosphamide and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 10 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

This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
nab paclitaxel, Cyclophosphamide and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
10 sitesUnited States
Study dates
Apr 2008to Sep 2010
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed invasive adenocarcinoma of the breast or inflammatory breast cancer, with an interval between definitive breast surgery and study registration of <60 days.
  • Definitive surgical treatment must be either mastectomy or breast-conserving therapy with axillary lymph node dissection for operable breast cancer (pT1 4 [including inflammatory breast cancer], pN0 3, and M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
  • Patients with ≥1 axillary lymph node containing metastatic adenocarcinoma measuring >0.2 mm, OR lymph node-negative patients with high-risk features
  • Patients with HER2/neu positive or negative tumors (HER2 positivity must be documented by FISH positivity or IHC 3+).
  • Patients who are to receive trastuzumab must have normal cardiac function (MUGA [cardiac ejection fraction >50%, or greater than or equal to the institutional lower limit of normal], or echocardiogram [ECHO] within institutional normal limits).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
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  • Patients who are either chemotherapy naïve, or who have received prior chemotherapy >5 years ago.
  • Patients with previous invasive cancers (including breast cancer) eligible only if treated >5 years prior to entering this study, and show no evidence of recurrent disease.
  • Adequate bone marrow function
  • Adequate liver function,
  • Adequate renal function,
  • Patients of childbearing potential must use an effective method of contraception that is acceptable to their study physician from the time of signing informed consent until at least 3 months after the last dose of protocol treatment, and must have a negative pre study serum pregnancy test.
  • Pre-existing peripheral neuropathy must be less than or equal to grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria.
  • MammoSite® brachytherapy radiation accepted when performed immediately following surgery and prior to receiving chemotherapy.
  • Patients with bilateral, synchronous breast cancer, provided that one primary tumor meets the inclusion criteria.

Who cannot join

  • Patients who are pregnant or breastfeeding.
  • M1 metastatic disease.
  • Patients requiring neoadjuvant chemotherapy.
  • Life expectancy of greater than 6 months.
  • History of cardiac disease, with a New York Heart Association (NYHA) Class II or greater CHF
  • Myocardial infarction (MI) or unstable angina in the past 12 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment, any history of stroke or transient ischemic attack at any time, clinically significant peripheral vascular disease, or evidence of a bleeding diathesis or coagulopathy.
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  • Any investigational agent within 30 days of receiving the first dose of study drug.
  • Treatment with prior trastuzumab or bevacizumab therapy.
  • Concurrent treatment with any other anti-cancer therapy is not permitted.
  • History of significant psychiatric disorders.
  • History of active, uncontrolled infection.
  • A serious, non-healing wound, ulcer, or bone fracture.
  • Any other diseases, metabolic dysfunction, findings from a physical examination, or clinical laboratory test results that give reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results or that renders the patient at high risk from treatment complications.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Mercy Hospital

    Portland, Maine, 04101

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)

This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.

Read the detailed description

Given the favorable activity demonstrated in a trial using the taxane docetaxel in combination with cyclophosphamide, we propose a Phase II trial of 4 cycles of weekly nab paclitaxel combined with cyclophosphamide. The favorable toxicity profile for weekly nab paclitaxel, in addition to its demonstrated superiority over standard paclitaxel in early-stage breast cancer, makes it an ideal taxane to evaluate in this setting. In this study, nab paclitaxel will be administered once weekly, in combination with q3wk cyclophosphamide. By using this combination therapy method, the goal of this study is to maximize the opportunity to demonstrate improved tolerability of adjuvant nab paclitaxel using a weekly dosing schedule in combination with q3wk cyclophosphamide.

In this study, patients who demonstrate FISH or IHC3+ HER2 positivity and adequate cardiac function will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Trastuzumab will be administered IV using an 8 mg/kg loading dose on Day 1 of the treatment period. If no toxicity occurs, subsequent doses of trastuzumab will be administered IV as a 6 mg/kg dose approximately every 21 days for a total of 52 weeks (thus, maintenance therapy with trastuzumab will continue after the 12-week period of combination therapy with nab paclitaxel/cyclophosphamide/trastuzumab has ended).

Conditions
Breast Cancer
Keywords
Early Stage Breast Cancer, Her2-positive, nab paclitaxel, cyclophosphamide, trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • nab paclitaxelDrug

    Also called Abraxane

    100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)

  • CyclophosphamideDrug

    Also called Cytoxan

    600 mg/m2 of IV cyclophosphamide

  • TrastuzumabDrug

    Also called Herceptin

    8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.

Study groups in NCT00629499
Study groupRoleWhat they receive
InterventionExperimental100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
Receives: Drug: nab paclitaxel; Drug: Cyclophosphamide; Drug: Trastuzumab

What is being measured

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

  1. Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel

    Measured: 18 Months

Secondary outcomes (2)

  1. Disease-free Survival

    Number of participants that are disease free at 18th month

    Measured: 18 Months

  2. Overall Survival

    Number of participants that are alive at 18th month

    Measured: 18 Months

Timeline

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

  1. First posted6 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionOct 2008
  4. Study completionSep 2010

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00629499
Sponsor's protocol ID
SCRI BRE 116
Status last verified
Nov 2021
First submitted
26 Feb 2008
Last updated
24 Nov 2021
Data monitoring committee
No

Publications

  • Yardley D, Burris H 3rd, Peacock N, Raefsky E, Melnik M, Inhorn R, Shipley D, Hainsworth J. A pilot study of adjuvant nanoparticle albumin-bound (nab) paclitaxel and cyclophosphamide, with trastuzumab in HER2-positive patients, in the treatment of early-stage breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):471-5. doi: 10.1007/s10549-010-1047-0. Epub 2010 Jul 24.

    PubMed 20658263

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab paclitaxel, Cyclophosphamide and Trastuzumab in people with Breast Cancer, run by SCRI Development Innovations, LLC at 10 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 15 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 24 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 10 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 20 Dec 2012). 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?

Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel (time frame: 18 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 NCT00629499, which also lists 1 linked publication.

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 24 Nov 2021.

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