Breast CancerPhase 3SUCCESS-CNCT00847444
Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention
A Phase 3 study testing Drug-based intervention and Lifestyle-based Intervention in people with Breast Cancer, run by Philip Hepp at 1 site in Germany.
Trial summary
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles… 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?
- Drug-based intervention and Lifestyle-based Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,547 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Sep 2016
- 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
Patients may be included in the study only if they meet all the following criteria:
- Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0
- No evidence of HER2/neu overexpressing (IHC neg or +) or amplifying (FISH neg.) tumor
- Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as at least one criterion of the following: 'pT ≥2, 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
- Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l and platelets ≥ 100 x 109/l
- Bilirubin within 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
- Willingness to participate in a telephone-based lifestyle intervention programme [10.] Intention of regular follow up visits for the duration of the study [11.] Ability to understand the nature of the study and to give written informed consent
Patients will be excluded from the study for any of the following reasons:
- 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 against Docetaxel, Epirubicine, Cyclophosphamide, 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 infroamtion, have to be respected
- Use of any investigational agent within 3 weeks prior to inclusion
- Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured)
- Insulin-requiring diabetes mellitus (non-insulin requiring patients with type 2 diabetes are eligible for the study)
- Serious digestive and/or absorptive problems that exclude adherence to the study diet [10.] Self-reported inability to walk at least one kilometer (at any pace) [11.] Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for exclusion [12.] Psychiatric disorders or conditions that would preclude participation in the study intervention [13.] Patients not sufficiently fluent in German language to understand the nature of this study and any of the interventional measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention Strategies
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40 kg/m² after randomisation with versus without the lifestyle intervention. Patients will be required to have histopathological proof of a HER2/neu negative tumor and: 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 status, 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.
Read the detailed description
Rationale:
- Taxane based chemotherapy will be established as treatment standard in the adjuvant setting of early breast cancer
- 3xFEC100, followed by 3xDoc100 has been established as standard treatment option for node-positive breast cancer
- Anthracycline based regimens do not seem to be superior in Her2/neu-negative patients (Gennari et al., Slamon et al.)
- Dietary intervention can improve outcome in patients with early breast cancer (WINS, Chlebowski et al.)
Primary Endpoints:
- The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide
- The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention
Design:
Prospectively randomized open label Phase III study with 2x2 factorial design
- Conditions
- Breast Cancer
- Being tested
- Drug-based intervention, Lifestyle-based Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-based interventionDrug
Randomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 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 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22
Lifestyle-based InterventionBehavioural
All Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows:
Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| AA | Active comparator | Drug intervention Receives: Drug: Drug-based intervention |
| BA | Active comparator | Lifestyle intervention Receives: Behavioral: Lifestyle-based Intervention |
| BB | No intervention | No individualized lifestyle intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide
Measured: 60 months
Secondary outcomes (1)
The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionSep 2016 (estimated)
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
- 3,547 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Hepp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip Hepp, Ludwig-Maximilians - University of Munich
- Investigators
- Wolfgang Janni, Prof. Dr. med., Study director, Klinikum der Heinrich-Heine-Universität Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847444
- Sponsor's protocol ID
- SUCCESS-C Trial
- Acronym
- SUCCESS-C
- Status last verified
- Apr 2013
- First submitted
- 17 Feb 2009
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as Well as Life Style Intervention Strategies
- ClinicalTrials.gov ID
- NCT00847444
- Acronym / sponsor ID
- SUCCESS-C / SUCCESS-C Trial
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,547 participants (estimated)
- Lead sponsor
- Philip HeppUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Feb 2009 (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, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicine-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(D)-chemotherapy, versus 6 cycles of Docetaxel- Cyclophosphamide (DC)-chemotherapy, and to compare the disease free survival in patients with BMI of 24 - 40 kg/m² after randomisation with versus without the lifestyle intervention. Patients will be required to have histopathological proof of a HER2/neu negative tumor and: 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 status, 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.
Detailed description
Rationale:
- Taxane based chemotherapy will be established as treatment standard in the adjuvant setting of early breast cancer
- 3xFEC100, followed by 3xDoc100 has been established as standard treatment option for node-positive breast cancer
- Anthracycline based regimens do not seem to be superior in Her2/neu-negative patients (Gennari et al., Slamon et al.)
- Dietary intervention can improve outcome in patients with early breast cancer (WINS, Chlebowski et al.)
Primary Endpoints:
- The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide
- The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention
Design:
Prospectively randomized open label Phase III study with 2x2 factorial design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AA | Active comparator | Drug: Drug-based interventionDrug intervention |
| BA | Active comparator | Behavioral: Lifestyle-based InterventionLifestyle intervention |
| BB | No intervention | –No individualized lifestyle intervention program. |
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 |
|---|---|---|
| Drug-based interventionRandomization A AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicine 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 AB: 6 cycles of Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² i.v. body surface area i.v. (DC), administered on day 1, repeated on day 22 | Drug | AA |
| Lifestyle-based InterventionAll Patients with a Body Mass Index (BMI) of 24 - 40 kg/m² at the time of enrollment will be subsequently randomized as follows: Second randomization B BA: Lifestyle intervention program to reduce body weight comprising individual weight loss, diet and physical activity goals in the framework of a 2-year standardized and structured telephone and mail-based intervention. | Behavioural | BA |
Primary outcome
The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide
Time frame: 60 months
1 secondary outcome
The second primary objective of this study is to compare disease free survival after randomisation in patients with vs. without lifestyle intervention
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- SUCCESS-Trial homepageLink 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.
Wolfgang Janni, Prof. Dr. med. study director
Klinikum der Heinrich-Heine-Universität Düsseldorf
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 Drug-based intervention and Lifestyle-based Intervention in people with Breast Cancer, run by Philip Hepp 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?
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 19 Apr 2013. 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?
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?
The first primary objective of this study is to compare disease free survival after randomisation in patients treated with a combination of 5-FU/Epirubicine/Cyclophosphamide followed by Docetaxel vs. Docetaxel/Cyclophosphamide (time frame: 60 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 19 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.