Breast CancerPhase 3NCT00670878
Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer
A Phase 3 study testing 3 x FEC 3 x DOC / Gemcitabine and 3 x FEC 3 x DOC in people with Breast Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This is an open-label, multicenter randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of Docetaxel (D)-chemotherapy versus 3 cycles of… 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?
- 3 x FEC 3 x DOC / Gemcitabine and 3 x FEC 3 x DOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 799 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Oct 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, M0
- Evidence of HER2-neu overexpressing (IHC +++) or amplifying (FISH +) tumor
- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as at least two criteria of the following: 'pT³2, histopathological grade 3, age £ 35, negative hormone receptor'
- Complete resection of the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
- Females >= 18 years of age
- Performance Status <2 on ECOG-Scale
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- Adequate bone marrow reserve: leucocytes ³ 3.0 x 109/l and platelets ³ 100 x 109/l
- Bilirubin within one fold of the reference laboratory's normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory's normal range for patients
- Intention of regular follow up visits for the duration of the study
- Ability to understand the nature of the study and to give written informed consent
- Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index < 1, e.g. , intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
Who cannot join
- Inflammatory breast cancer
- Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
- A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrhythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
- Any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide, gemcitabine or any other medication included in the study protocol. The contraindication, warning notices and measures of precaution of the products, as notified in the product information, have to be respected
- Instable diabetes mellitus, out of sufficient medical control
- Use of any investigational agent within 3 weeks prior to inclusion
- Patients in pregnancy or breast feeding (in premenopausal women contraception has to be assured)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Frauenklinik der Universität München Campus Innenstadt
Munich, 80337
About this study
Official title: Prospectively Randomized Phase III Trial, Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer
This is an open-label, multicenter randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of Docetaxel (D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide (FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)- chemotherapy. Patients will be required to have HER2-neu positive disease and histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>=2 or histopathological grade 3, or age <= 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.
- Conditions
- Breast Cancer
- Being tested
- 3 x FEC 3 x DOC / Gemcitabine, 3 x FEC 3 x DOC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 x FEC 3 x DOC / GemcitabineDrug
3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22
3 x FEC 3 x DOCDrug
3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: 3 x FEC 3 x DOC / Gemcitabine |
| B | Active comparator | Not described Receives: Drug: 3 x FEC 3 x DOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 5 y
Secondary outcomes (7)
Overall survival time after randomization
Measured: 5 Y
Distant disease free survival
Measured: 5 Y
Toxicity
Measured: 5 Y
Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire
Measured: 5 Y
Skeletal related events
Measured: 5 Y
Incidence of secondary primaries
Measured: 5 Y
Endpoints of adjunct translational research program
Measured: 5 Y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2011
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 799 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Hepp, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670878
- Sponsor's protocol ID
- SUCCESS-B
- Status last verified
- Mar 2012
- First submitted
- 30 Apr 2008
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Randomized Phase III Trial, Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00670878
- Acronym / sponsor ID
- SUCCESS-B
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 799 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2011 (actual)
- First posted
- 2 May 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.
This is an open-label, multicenter randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of Docetaxel (D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide (FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)- chemotherapy. Patients will be required to have HER2-neu positive disease and histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>=2 or histopathological grade 3, or age <= 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 3 x FEC 3 x DOC / Gemcitabine |
| B | Active comparator | Drug: 3 x FEC 3 x DOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, M0
- Evidence of HER2-neu overexpressing (IHC +++) or amplifying (FISH +) tumor
- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as at least two criteria of the following: 'pT³2, histopathological grade 3, age £ 35, negative hormone receptor'
- Complete resection of the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
- Females >= 18 years of age
Key exclusion criteria (8 listed)
- Inflammatory breast cancer
- Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
- A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrhythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
- Any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide, gemcitabine or any other medication included in the study protocol. The contraindication, warning notices and measures of precaution of the products, as notified in the product information, have to be respected
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 |
|---|---|---|
| 3 x FEC 3 x DOC / Gemcitabine3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22 | Drug | A |
| 3 x FEC 3 x DOC3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22 | Drug | B |
Primary outcome
Disease free survival
Time frame: 5 y
7 secondary outcomes
Overall survival time after randomization
Time frame: 5 Y
Distant disease free survival
Time frame: 5 Y
Toxicity
Time frame: 5 Y
Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire
Time frame: 5 Y
Skeletal related events
Time frame: 5 Y
Incidence of secondary primaries
Time frame: 5 Y
Endpoints of adjunct translational research program
Time frame: 5 Y
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 3 Apr 2012.
- Related InfoLink provided by the sponsor.
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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 3 x FEC 3 x DOC / Gemcitabine and 3 x FEC 3 x DOC in people with Breast Cancer, run by Ludwig-Maximilians - University of Munich 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 11 inclusion and 8 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 3 Apr 2012. 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?
Disease free survival (time frame: 5 y). 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 3 Apr 2012.