Breast CancerPhase 3NCT00668616
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
A Phase 3 study testing Cyclophosphamide, Epirubicin, Paclitaxel and Epirubicin, Paclitaxel, Filgrastim in people with Breast Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cyclophosphamide, Epirubicin, Paclitaxel and Epirubicin, Paclitaxel, Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,034 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2000to Jul 2009
- Phase
- Phase 3
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
- ECOG performance status 0-1
- start of adjuvant therapy not later than 4 weeks after surgery
- hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
- normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
- normal kidney function as defined by: creatine till 1.5 x normal value
- negative pregnancy test for patients before menopause and effective contraception
- written informed consent
Who cannot join
- prior radiation, chemotherapy, hormontherapy and immunotherapy
- patients with more than 3 afflicted lymph nodes
- afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
- bilateral breast cancer or second carcinoma of the breast
- inflammatory breast cancer and/or distant metastases
- existing clinically relevant peripheral neuropathie
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- heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
- patients with active infections and/or not controlled hypercalcemia
- pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
- Conditions
- Breast Cancer
- Being tested
- Cyclophosphamide, Epirubicin, Paclitaxel, Epirubicin, Paclitaxel, Filgrastim
- Keywords
- breast cancer with 1-3 afflicted axillary lymph nodes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Epirubicin, PaclitaxelDrug
4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d
Epirubicin, Paclitaxel, FilgrastimDrug
cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Cyclophosphamide, Epirubicin, Paclitaxel |
| 2 | Experimental | Not described Receives: Drug: Epirubicin, Paclitaxel, Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free time
Measured: every 3-6 months
Secondary outcomes (2)
toxicity
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startMar 2000
- Primary completionJul 2005
- Study completionJul 2009
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Eastern German Society of Gynaecological Oncology
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668616
- Sponsor's protocol ID
- 170200
- Status last verified
- Jul 2010
- First submitted
- 25 Apr 2008
- Last updated
- 29 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)
- ClinicalTrials.gov ID
- NCT00668616
- Acronym / sponsor ID
- 170200
- Conditions
- Breast Cancer
- Keywords
- breast cancer with 1-3 afflicted axillary lymph nodes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- North Eastern German Society of Gynaecological OncologyUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Apr 2008 (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.
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Cyclophosphamide, Epirubicin, Paclitaxel |
| 2 | Experimental | Drug: Epirubicin, Paclitaxel, Filgrastim |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
- ECOG performance status 0-1
- start of adjuvant therapy not later than 4 weeks after surgery
- hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
- normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
Key exclusion criteria (9 listed)
- prior radiation, chemotherapy, hormontherapy and immunotherapy
- patients with more than 3 afflicted lymph nodes
- afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
- bilateral breast cancer or second carcinoma of the breast
- inflammatory breast cancer and/or distant metastases
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 |
|---|---|---|
| Cyclophosphamide, Epirubicin, Paclitaxel4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d | Drug | 1 |
| Epirubicin, Paclitaxel, Filgrastimcycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) | Drug | 2 |
Primary outcome
progression-free time
Time frame: every 3-6 months
2 secondary outcomes
toxicity
overall survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Epirubicin, Paclitaxel and Epirubicin, Paclitaxel, Filgrastim in people with Breast Cancer, run by North Eastern German Society of Gynaecological Oncology at 1 site in Germany.
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 8 inclusion and 9 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 29 Jul 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
progression-free time (time frame: every 3-6 months). 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 29 Jul 2010.