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Breast CancerPhase 2NCT00398489

Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

A Phase 2 study testing trastuzumab, anastrozole and cyclophosphamide in people with Breast Cancer, run by Technical University of Munich at 5 sites in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide, 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 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab, anastrozole and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
94 participants
Where
5 sitesGermany
Study dates
Oct 2006to not given
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary carcinoma of the breast by core biopsy
  • Solitaire or multifocal disease, defined as tumor manifestations within a quadrant or distance between tumor manifestations measured bilaterally < 4 cm, respectively
  • No multifocal primary tumor, defined as tumor manifestations in different quadrants or distance between tumor manifestations ≥ 4 cm
  • Locally advanced, operable disease
  • Primary tumor ≥ 2 cm by clinical examination or imaging (i.e., mammogram, MRI, or ultrasound)
  • Inflammatory breast cancer with bidimensionally measurable lesion, independent of nodal status, allowed
  • HER2 status meeting 1 of the following criteria:
  • HER2-positive disease
  • 3+ by immunohistochemistry (IHC) and/or positive by fluorescence in situ hybridization (FISH)
  • HER-2 negative disease
  • 0 or 1+ by IHC OR 2+ by IHC and negative by FISH
  • No distant metastases by clinical or imaging diagnosis
  • No prior breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Pre- or post-menopausal
  • ECOG performance status 0-2
  • Platelet count ≥ 100,000/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 10 g/dL
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Bilirubin normal (unless due to clearly documented Gilbert's syndrome)
  • Not pregnant or nursing
  • Negative pregnancy test (for premenopausal women or women with a postmenopausal status for < 1 year)
  • Fertile patients must use effective contraception
  • Adequate organ function for cytotoxic chemotherapy
  • No known hypersensitivity reaction to the study agents or incorporated substances
  • No known allergy or severe reactions to trastuzumab or its constituents (for patients with HER2-positive disease)
  • No preexisting motor or sensory neuropathy ≥ grade 2
  • No other invasive malignancy within the past 5 years that would preclude study compliance or affect the interpretation of study results
  • LVEF ≥ 55% by MUGA or echocardiography
  • No other serious illness or medical condition, including any of the following:
  • New York Heart Association class II-IV congestive heart failure
  • History of documented congestive heart failure
  • Unstable angina pectoris
  • Myocardial infarction within the past 12 months
  • Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
  • Clinically significant valvular heart disease
  • High-risk, uncontrolled arrhythmias
  • Dyspnea at rest due to malignant or other disease
  • Condition that requires supportive oxygen therapy
  • Active serious uncontrolled infections
  • Uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

  • No prior systemic therapy for cancer
  • No prior trastuzumab (Herceptin^®) (for HER2-positive patients)
  • No other concurrent anticancer therapy
  • No other concurrent investigational drugs
  • No concurrent immunosuppressive therapy
  • No concurrent sex hormones
  • No concurrent corticosteroids unless for premedication
  • No concurrent bisphosphonates during active treatment with chemotherapy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites
  • Klinikum Bayreuth

    Bayreuth, D 95448

  • Universitaetsfrauenklinik - Koeln

    Cologne, D-50391

  • Klinikum Deggendorf

    Deggendorf, 94469

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07743

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

Other trials in Germany

About this study

Official title: Evaluation of Response Rate to Pre-Operative Docetaxel + Herceptin Study Part A and Docetaxel Study Part B in Locally Advanced Breast Cancer Patients, Stratified by HER2-Status Trial - PHASE II [(Herceptin Docetaxel Neoadjuvant) HEDON]

RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide, 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 with or without monoclonal antibody therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving docetaxel, epirubicin, and cyclophosphamide with or without trastuzumab works in treating women with locally advanced breast cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) and adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and trastuzumab (Herceptin®) followed by radiotherapy in women with locally advanced, HER2-positive, operable breast cancer.
  • Determine the efficacy of neoadjuvant therapy with docetaxel and adjuvant therapy comprising epirubicin hydrochloride and cyclophosphamide followed by radiotherapy in women with locally advanced, HER2-negative, operable breast cancer.

OUTLINE: This is an open-label, prospective, multicenter study. Patients are stratified according to HER2 status (positive vs negative).

  • Neoadjuvant therapy:
  • Stratum 1 (HER2-positive disease): Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, and 15 and docetaxel IV over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
  • Stratum 2 (HER2-negative disease): Patients receive docetaxel IV alone as in stratum 1.
  • Surgery: All patients undergo surgery in week 19.
  • Adjuvant therapy: Beginning within 2 weeks after surgery, patients receive adjuvant therapy.
  • Stratum 1 (HER2-positive disease): Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, and 15, epirubicin hydrochloride IV over 30 minutes on day 2, and cyclophosphamide IV over 30 minutes on day 2. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV alone every 3 weeks until week 52.
  • Stratum 2 (HER2-negative disease): Patients receive epirubicin hydrochloride and cyclophosphamide as in stratum 1.
  • Radiotherapy: Patients who undergo breast conserving surgery or patients who undergo mastectomy with ypN positive lymph nodes (i.e., > 4 positive lymph nodes) or ypT3 tumor (i.e., tumor size > 4 cm) undergo radiotherapy, beginning in approximately week 31 and continuing until up to week 38.
  • Adjuvant endocrine therapy: Patients with estrogen receptor- or progesterone receptor-positive disease receive adjuvant endocrine therapy beginning in approximately week 31. Premenopausal patients ≤ 40 years of age receive goserelin for 2-3 years and tamoxifen citrate for 5 years.Premenopausal patients > 40 years of age receive tamoxifen citrate for 5 years. Postmenopausal patients receive anastrozole for 5 years years.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
trastuzumab, anastrozole, cyclophosphamide, docetaxel, epirubicin hydrochloride
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer, inflammatory breast cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

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

What is being measured

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

  1. Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer

  2. Rate of pCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer

  3. Tolerability of treatment as measured by the nature and frequency of adverse events in women with HER2-positive or HER2-negative disease

  4. Identification of predictive markers

Secondary outcomes (6)
  1. Rate of breast conserving therapy versus mastectomy in comparison to preoperative evaluation

  2. Correlation of clinical/sonographical response with pathological response, including lymph node status

  3. Rate of clinical complete remission (cCR) after neoadjuvant therapy comprising docetaxel and trastuzumab in women with locally advanced, HER2-positive, operable breast cancer

  4. Rate of cCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer

  5. Disease-free survival after 2.5 and 5 years

  6. Overall-survival after 2.5 and 5 years

Timeline

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

  1. First posted10 Nov 2006 (estimated)
  2. Study startOct 2006

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
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398489
Sponsor's protocol ID
CDR0000516034
Other IDs
KRDI-TUM-HED-324-PAE-0090-I, EU-20634, EUDRACT-2005-000967-24
Status last verified
Sep 2008
First submitted
9 Nov 2006
Last updated
9 Nov 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, anastrozole and cyclophosphamide in people with Breast Cancer, run by Technical University of Munich at 5 sites in Germany.

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: status not confirmed, as of the sponsor's last update on 9 Nov 2010. 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 Germany. 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?

Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Nov 2010.

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