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.
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
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.
trastuzumabBiological
anastrozoleDrug
cyclophosphamideDrug
docetaxelDrug
epirubicin hydrochlorideDrug
goserelin acetateDrug
tamoxifen citrateDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer
Rate of pCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer
Tolerability of treatment as measured by the nature and frequency of adverse events in women with HER2-positive or HER2-negative disease
Identification of predictive markers
Secondary outcomes (6)
Rate of breast conserving therapy versus mastectomy in comparison to preoperative evaluation
Correlation of clinical/sonographical response with pathological response, including lymph node status
Rate of clinical complete remission (cCR) after neoadjuvant therapy comprising docetaxel and trastuzumab in women with locally advanced, HER2-positive, operable breast cancer
Rate of cCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer
Disease-free survival after 2.5 and 5 years
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.
- First posted10 Nov 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Paepke, MD, Study chair, Technical University of Munich
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT00398489
- Acronym / sponsor ID
- CDR0000516034
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer, inflammatory breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| anastrozole | Drug | – |
| cyclophosphamide | Drug | – |
| docetaxel | Drug | – |
| epirubicin hydrochloride | Drug | – |
| goserelin acetate | Drug | – |
| tamoxifen citrate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer
Rate of pCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer
Tolerability of treatment as measured by the nature and frequency of adverse events in women with HER2-positive or HER2-negative disease
Identification of predictive markers
6 secondary outcomes
Rate of breast conserving therapy versus mastectomy in comparison to preoperative evaluation
Correlation of clinical/sonographical response with pathological response, including lymph node status
Rate of clinical complete remission (cCR) after neoadjuvant therapy comprising docetaxel and trastuzumab in women with locally advanced, HER2-positive, operable breast cancer
Rate of cCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer
Disease-free survival after 2.5 and 5 years
Overall-survival after 2.5 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Paepke, MD study chair
Technical University of Munich
5 sites in 1 country: see every site and its status.
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.