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Breast CancerPhase 2NCT00379015

Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

A Phase 2 study testing trastuzumab, cyclophosphamide and docetaxel in people with Breast Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 5 sites in Japan.

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

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 20 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab, cyclophosphamide and docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
5 sitesJapan
Study dates
Jan 2006to Mar 2016
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 20 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of primary breast cancer
  • Stage IIIB, IIIC, or IV disease
  • No inflammatory disease
  • HER2 over-expressing tumor as assessed by immunohistochemistry and/or fluorescent in situ hybridization
  • Hormone receptor status known

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Performance status 0-1
  • WBC ≤ 10,000/mm³
  • Absolute neutrophil count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.5 g/dL
  • SGOT/SGPT ≤ 60 IU/L
  • Bilirubin ≤ 1.5 mg/dL
  • Creatinine ≤ 1.5 mg/dL
  • LVEF ≥ 55%
  • No signs of pneumonitis

PRIOR CONCURRENT THERAPY:

  • No prior surgery except for biopsy
  • No prior or concurrent chemotherapy and/or hormonal therapy
  • No prior or concurrent biological therapy
  • No prior or concurrent radiotherapy except postoperative radiotherapy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • National Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0288

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Keio University Hospital

    Tokyo, Tokyo, 160-8582

  • Teikyo University School of Medicine

    Tokyo, Tokyo, 173-8605

Other trials in Japan

About this study

Official title: Neoadjuvant Epirubicin/Cyclophosphamide Followed by Docetaxel Combined With Trastuzumab for the Patients With HER-Positive Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB, stage IIIC, or stage IV primary breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the pathological complete response in women with HER2-positive stage IIIB-IV breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®).

Secondary

  • Determine the clinical response in patients treated with this regimen.
  • Determine the recurrence-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses.

Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
trastuzumab, cyclophosphamide, docetaxel, epirubicin hydrochloride, conventional surgery
Keywords
stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT00379015
Study groupRoleWhat they receive
HER2 over-expressing primary breast cancer groupExperimentalPatients receive epirubicin hydrochloride and cyclophosphamide in week 1-3. Treatment with epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with docetaxel and trastuzumab repeats every 3 weeks for 4 courses. Patients then undergo appropriate surgery. After surgery, patients with hormone receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment continues for 40 weeks.
Receives: Biological: trastuzumab; Drug: cyclophosphamide; Drug: docetaxel; Drug: epirubicin hydrochloride; Procedure: conventional surgery; Procedure: neoadjuvant therapy

What is being measured

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

  1. Pathological complete response

    Pathological complete response is assessed in surgical resected specimens of primary tumor from patients who underwent a primary radical surgery in this study.

    Measured: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab

Secondary outcomes (5)

  1. Clinical response

    Clinical response is assessed as overall response in target lesion of primary tumor from 7 days after the last administration of neoadjuvant therapy of Trastuzumab until surgery.

    Measured: From 7 days after the last adoministration of neosdjuvant therapy of Trastuzumab until surgery.

  2. Pathological response of axillary lymph nodes

    Pathological response of axillary lymph nodes is assessed in surgical specimens of primary tumor from patients who underwent a primary radical surgery in this study.

    Measured: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab.

  3. Recurrence-free survival

    Recurrence-free survival is defined as time from date of enrollment until date of recurrence or death from any cause, whichever comes first.

    Measured: 8 years

  4. Overall survival

    Overall survival is defined as time from date of enrollment until date of death from any cause.

    Measured: 8 years

  5. Adverse event

    Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.

    Measured: 70 months

Timeline

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

  1. First posted21 Sep 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2016
  4. Study completionMar 2016

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379015
Sponsor's protocol ID
CDR0000496448
Other IDs
TUSM-BRI-BC04-01
Status last verified
Sep 2016
First submitted
19 Sep 2006
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, cyclophosphamide and docetaxel in people with Breast Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. 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?

Pathological complete response (time frame: Whitin the first 7-28 days after the last administration of neoadjuvant therapy of trastuzumab). 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 NCT00379015.

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 28 Sep 2016.

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